Trial Outcomes & Findings for A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure (NCT NCT01641367)
NCT ID: NCT01641367
Last Updated: 2019-03-15
Results Overview
The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive). The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA\>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA \>200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
545 participants
Primary outcome timeframe
48 weeks after the date of entry
Results posted on
2019-03-15
Participant Flow
Participants were enrolled between 22FEB2013 and 21DEC2015 at non-US based clinical research sites.
Participant milestones
| Measure |
Experimental: Cohort A
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
Cell Phone Intervention (CPI) + Standard of Care (SOC)
The CPI was a simple interactive system (Short Message Service \[SMS\] Reminder and Flashback System) to identify non-adherence soon after it occurred and, in response, a site-based culturally relevant algorithm for managing barriers to adherence. Reminders were sent daily for the first 8 weeks on study, then three times per week for the next 8 weeks, and then weekly through to 48 weeks after study entry. Participants were expected to respond ("flashback") to each reminder. Failure to respond, triggered the system to alert the site to contact the participant. Sites were instructed to contact the participant if they missed any three flashbacks over two weeks during the daily messaging period, any two missed flashbacks over two weeks of the three times a week messaging period, and any two missed flashbacks over two weeks during the weekly messaging period. Additionally, sites were instructed to continue the local standard of care practices for managing adherence barriers.
|
Standard of Care (SOC)
Sites were instructed to continue the local standard of care practices for managing adherence barriers.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts
STARTED
|
287
|
74
|
72
|
8
|
70
|
34
|
0
|
0
|
|
Cohorts
Followed 72 Weeks on Step 1/2
|
211
|
60
|
60
|
6
|
52
|
30
|
0
|
0
|
|
Cohorts
COMPLETED
|
253
|
73
|
68
|
8
|
67
|
33
|
0
|
0
|
|
Cohorts
NOT COMPLETED
|
34
|
1
|
4
|
0
|
3
|
1
|
0
|
0
|
|
Randomized Adherence Intervention
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
257
|
264
|
|
Randomized Adherence Intervention
Followed 72 Weeks on Step 1/2
|
0
|
0
|
0
|
0
|
0
|
0
|
196
|
202
|
|
Randomized Adherence Intervention
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
238
|
240
|
|
Randomized Adherence Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
24
|
Reasons for withdrawal
| Measure |
Experimental: Cohort A
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
Cell Phone Intervention (CPI) + Standard of Care (SOC)
The CPI was a simple interactive system (Short Message Service \[SMS\] Reminder and Flashback System) to identify non-adherence soon after it occurred and, in response, a site-based culturally relevant algorithm for managing barriers to adherence. Reminders were sent daily for the first 8 weeks on study, then three times per week for the next 8 weeks, and then weekly through to 48 weeks after study entry. Participants were expected to respond ("flashback") to each reminder. Failure to respond, triggered the system to alert the site to contact the participant. Sites were instructed to contact the participant if they missed any three flashbacks over two weeks during the daily messaging period, any two missed flashbacks over two weeks of the three times a week messaging period, and any two missed flashbacks over two weeks during the weekly messaging period. Additionally, sites were instructed to continue the local standard of care practices for managing adherence barriers.
|
Standard of Care (SOC)
Sites were instructed to continue the local standard of care practices for managing adherence barriers.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts
Death
|
18
|
1
|
2
|
0
|
1
|
1
|
0
|
0
|
|
Cohorts
Lost to Follow-up
|
16
|
0
|
2
|
0
|
2
|
0
|
0
|
0
|
|
Randomized Adherence Intervention
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
12
|
|
Randomized Adherence Intervention
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
12
|
Baseline Characteristics
A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure
Baseline characteristics by cohort
| Measure |
Experimental: Cohort A
n=287 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=74 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=70 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
n=34 Participants
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
Total
n=545 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 11 • n=5 Participants
|
42 years
STANDARD_DEVIATION 10 • n=7 Participants
|
42 years
STANDARD_DEVIATION 9 • n=5 Participants
|
40 years
STANDARD_DEVIATION 10 • n=4 Participants
|
42 years
STANDARD_DEVIATION 10 • n=21 Participants
|
42 years
STANDARD_DEVIATION 10 • n=8 Participants
|
41 years
STANDARD_DEVIATION 10 • n=8 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
258 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
287 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
63 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
241 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
454 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
146 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
195 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
353 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
31 Participants
n=8 Participants
|
|
Region of Enrollment
Brazil
|
25 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
49 Participants
n=8 Participants
|
|
Region of Enrollment
Haiti
|
34 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Region of Enrollment
India
|
55 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
128 Participants
n=8 Participants
|
|
Region of Enrollment
Kenya
|
32 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
59 Participants
n=8 Participants
|
|
Region of Enrollment
Malawi
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Region of Enrollment
Peru
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
58 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
84 Participants
n=8 Participants
|
|
Region of Enrollment
Thailand
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Region of Enrollment
Uganda
|
34 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
81 Participants
n=8 Participants
|
|
Region of Enrollment
Zimbabwe
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Plasma HIV-1 RNA, categorical
< 40 copies/mL
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Plasma HIV-1 RNA, categorical
40 - < 200 copies/mL
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Plasma HIV-1 RNA, categorical
200 - < 1000 copies/mL
|
32 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
52 Participants
n=8 Participants
|
|
Plasma HIV-1 RNA, categorical
1000 - < 10,000 copies/mL
|
59 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
121 Participants
n=8 Participants
|
|
Plasma HIV-1 RNA, categorical
10,000 - < 100,000 copies/mL
|
106 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
175 Participants
n=8 Participants
|
|
Plasma HIV-1 RNA, categorical
100,000 - < 1,000,000 copies/mL
|
60 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
146 Participants
n=8 Participants
|
|
Plasma HIV-1 RNA, categorical
1,000,000 - < 10,000,000 copies/mL
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Plasma HIV-1 RNA, categorical
>= 10,000,000 copies/mL
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
CD4+ T-Cell Count, categorical
< 50 cells/mm^3
|
50 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
95 Participants
n=8 Participants
|
|
CD4+ T-Cell Count, categorical
50 - < 200 cells/mm^3
|
108 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
202 Participants
n=8 Participants
|
|
CD4+ T-Cell Count, categorical
200 - < 350 cells/mm^3
|
79 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
148 Participants
n=8 Participants
|
|
CD4+ T-Cell Count, categorical
350 - < 500 cells/mm^3
|
30 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
63 Participants
n=8 Participants
|
|
CD4+ T-Cell Count, categorical
>= 500 cells/mm^3
|
20 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
IV drug history, categorical
Never
|
286 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
544 Participants
n=8 Participants
|
|
IV drug history, categorical
Previously
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Hepatitis B Surface Antigen Result, categorical
Positive
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Hepatitis B Surface Antigen Result, categorical
Negative
|
273 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
515 Participants
n=8 Participants
|
|
Hepatitis B Surface Antigen Result, categorical
Indeterminate
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 48 weeks after the date of entryPopulation: All enrolled participants
The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive). The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA\>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA \>200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided.
Outcome measures
| Measure |
Overall Study
n=545 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=287 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=74 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=70 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
n=34 Participants
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks
|
0.64 proportion of participants
Interval 0.6 to 0.68
|
0.44 proportion of participants
Interval 0.38 to 0.49
|
0.88 proportion of participants
Interval 0.8 to 0.95
|
0.88 proportion of participants
Interval 0.8 to 0.95
|
1.00 proportion of participants
Interval 0.63 to 1.0
|
0.90 proportion of participants
Interval 0.83 to 0.97
|
0.74 proportion of participants
Interval 0.59 to 0.88
|
SECONDARY outcome
Timeframe: 24 weeks after the date of entryPopulation: All enrolled participants
The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive). The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA\>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA \>200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided.
Outcome measures
| Measure |
Overall Study
n=545 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=287 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=74 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=70 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
n=34 Participants
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks
|
0.64 proportion of participants
Interval 0.6 to 0.68
|
0.43 proportion of participants
Interval 0.37 to 0.48
|
0.89 proportion of participants
Interval 0.82 to 0.96
|
0.88 proportion of participants
Interval 0.8 to 0.95
|
1.00 proportion of participants
Interval 0.63 to 1.0
|
0.90 proportion of participants
Interval 0.83 to 0.97
|
0.74 proportion of participants
Interval 0.59 to 0.88
|
SECONDARY outcome
Timeframe: 72 weeks after the date of entryPopulation: All participants with results expected at week 72
The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive). The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA\>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA \>200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided.
Outcome measures
| Measure |
Overall Study
n=448 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=234 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=61 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=62 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=6 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=54 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
n=31 Participants
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks
|
0.64 proportion of participants
Interval 0.6 to 0.69
|
0.44 proportion of participants
Interval 0.37 to 0.5
|
0.92 proportion of participants
Interval 0.85 to 0.99
|
0.87 proportion of participants
Interval 0.79 to 0.95
|
1.00 proportion of participants
Interval 0.54 to 1.0
|
0.85 proportion of participants
Interval 0.76 to 0.95
|
0.77 proportion of participants
Interval 0.63 to 0.92
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-upPopulation: all enrolled participants
All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Number of Weeks of Follow-up
|
72 weeks
Interval 60.0 to 96.0
|
96 weeks
Interval 72.0 to 132.0
|
84 weeks
Interval 72.0 to 126.0
|
96 weeks
Interval 66.0 to 120.0
|
72 weeks
Interval 60.0 to 96.0
|
96 weeks
Interval 84.0 to 144.0
|
—
|
SECONDARY outcome
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All enrolled participants
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure \[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
10th percentile
|
24 weeks
Interval 24.0 to 24.0
|
NA weeks
Interval 24.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 90%
|
144 weeks
Interval 48.0 to
Not estimable as the upper limit for survival function at all weeks is above 90%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
120 weeks
Interval 24.0 to
Not estimable as the upper limit for survival function at all weeks is above 90%
|
24 weeks
Interval 24.0 to
Not estimable as the upper limit for survival function at all weeks is above 90%
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
25th percentile
|
24 weeks
Interval 24.0 to 24.0
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 144.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 75%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 120.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 75%
|
NA weeks
Interval 24.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 75%
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
50th percentile
|
60 weeks
Interval 48.0 to 96.0
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Interval 120.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
1st percentile
|
24 weeks
Interval 24.0 to 24.0
|
24 weeks
Interval 24.0 to 24.0
|
24 weeks
Interval 24.0 to 72.0
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
24 weeks
Interval 24.0 to 48.0
|
24 weeks
Interval 24.0 to 24.0
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
5th percentile
|
24 weeks
Interval 24.0 to 24.0
|
48 weeks
Interval 24.0 to
Not estimable as the upper limit for survival function at all weeks is above 95%
|
72 weeks
Interval 24.0 to
Not estimable as the upper limit for survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
48 weeks
Interval 24.0 to
Not estimable as the upper limit for survival function at all weeks is above 95%
|
24 weeks
Interval 24.0 to 48.0
|
—
|
SECONDARY outcome
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All enrolled participants
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure \[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
|
145 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: From week 24 to Week 48Population: All enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure \[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Confirmed Virologic Failure by Week 48
|
48.9 percentage of participants
Interval 42.8 to 54.7
|
8.2 percentage of participants
Interval 3.3 to 16.0
|
2.9 percentage of participants
Interval 0.1 to 9.0
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
5.8 percentage of participants
Interval 1.9 to 13.1
|
18.6 percentage of participants
Interval 7.4 to 33.8
|
—
|
SECONDARY outcome
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All enrolled participants
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure \[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
1st percentile
|
24 weeks
Interval 24.0 to 24.0
|
24 weeks
Interval 24.0 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
24 weeks
Interval 24.0 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
48 weeks
Interval 48.0 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
24 weeks
Interval 24.0 to 24.0
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
5th percentile
|
24 weeks
Interval 24.0 to 24.0
|
NA weeks
Interval 24.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 95%
|
NA weeks
Interval 24.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 48.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 95%
|
24 weeks
Interval 24.0 to 48.0
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
10th percentile
|
24 weeks
Interval 24.0 to 48.0
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 72.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 90%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 48.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 90%
|
24 weeks
Interval 24.0 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
25th percentile
|
144 weeks
Interval 72.0 to
Not estimable as the upper limit for the survival function at all weeks is above 75%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 24.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
—
|
SECONDARY outcome
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All enrolled participants
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure\[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
|
48 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: From week 24 to Week 48Population: All enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure\[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48
|
16.6 percentage of participants
Interval 12.3 to 21.5
|
1.4 percentage of participants
Interval 0.1 to 6.6
|
1.4 percentage of participants
Interval 0.1 to 6.7
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
1.5 percentage of participants
Interval 0.1 to 7.1
|
15.4 percentage of participants
Interval 5.5 to 29.9
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: all enrolled participants
Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to Death
1st percentile
|
11.3 weeks
Interval 4.0 to 17.7
|
3.1 weeks
Interval 3.1 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
44.6 weeks
Interval 44.6 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
77.9 weeks
Interval 77.9 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
2.4 weeks
Interval 2.4 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
—
|
|
Time From Study Entry/Randomization to Death
5th percentile
|
62.4 weeks
Interval 17.7 to 110.1
|
NA weeks
Interval 3.1 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 44.6 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 77.9 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 2.4 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
—
|
|
Time From Study Entry/Randomization to Death
10th percentile
|
NA weeks
Interval 82.1 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 51.4 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 77.9 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 2.4 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: all enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants Experiencing Death by Week 48
|
3.9 percentage of participants
Interval 2.0 to 6.6
|
1.4 percentage of participants
Interval 0.1 to 6.5
|
1.4 percentage of participants
Interval 0.1 to 6.7
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
2.9 percentage of participants
Interval 0.2 to 13.2
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: all enrolled participants
Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
1st percentile
|
4.0 weeks
Interval 4.0 to 11.3
|
3.1 weeks
Interval 3.1 to 34.0
|
16.3 weeks
Interval 16.3 to 44.6
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
3.3 weeks
Interval 3.3 to 26.6
|
2.4 weeks
Interval 2.4 to 24.0
|
—
|
|
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
5th percentile
|
27.6 weeks
Interval 11.3 to 42.9
|
36.0 weeks
Interval 3.1 to 84.0
|
50.3 weeks
Interval 16.3 to 120.0
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
36.0 weeks
Interval 3.3 to 119.1
|
24.0 weeks
Interval 2.4 to 72.0
|
—
|
|
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
10th percentile
|
57.9 weeks
Interval 37.3 to 79.7
|
84.0 weeks
Interval 4.6 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
120.0 weeks
Interval 36.0 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
77.9 weeks
Interval 3.6 to 142.4
|
48.4 weeks
Interval 2.4 to 84.0
|
—
|
|
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
25th percentile
|
NA weeks
Interval 118.6 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 88.7 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 120.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 75%
|
142.4 weeks
Interval 119.1 to
Not estimable as the upper limit for the survival function at all weeks is above 75%
|
96.3 weeks
Interval 48.4 to
Not estimable as the upper limit for the survival function at all weeks is above 75%
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: all enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48
|
8.8 percentage of participants
Interval 5.9 to 12.4
|
5.4 percentage of participants
Interval 1.7 to 12.2
|
4.2 percentage of participants
Interval 1.1 to 10.7
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
5.8 percentage of participants
Interval 1.8 to 13.0
|
5.9 percentage of participants
Interval 1.0 to 17.4
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: all enrolled participants
Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization.
1st percentile
|
2.4 weeks
Interval 1.0 to 5.9
|
2.3 weeks
Interval 2.3 to 10.9
|
3.0 weeks
Interval 3.0 to 25.6
|
16.4 weeks
Interval 16.4 to 16.4
|
2.0 weeks
Interval 2.0 to 3.3
|
2.3 weeks
Interval 2.3 to 5.6
|
—
|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization.
5th percentile
|
13.4 weeks
Interval 5.9 to 25.1
|
20.3 weeks
Interval 2.3 to 100.1
|
28.0 weeks
Interval 3.0 to 49.7
|
16.4 weeks
Interval 16.4 to
Not estimable as the upper limit for the survival function at all weeks is above 95%
|
7.7 weeks
Interval 2.0 to 84.9
|
5.6 weeks
Interval 2.3 to 96.1
|
—
|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization.
10th percentile
|
32.6 weeks
Interval 22.9 to 61.1
|
80.7 weeks
Interval 9.1 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
49.7 weeks
Interval 6.1 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
16.4 weeks
Interval 16.4 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
77.9 weeks
Interval 2.0 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
96.1 weeks
Interval 2.3 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
—
|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization.
25th percentile
|
120.1 weeks
Interval 97.3 to
Not estimable as the upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 100.1 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 90.7 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 16.4 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 84.9 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 96.1 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
—
|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization.
50th percentile
|
168.9 weeks
Interval 168.9 to
Not estimable as the upper limit for the survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Interval 16.4 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: all enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Death or Hospitalization by Week 48
|
12.3 percentage of participants
Interval 8.8 to 16.4
|
8.1 percentage of participants
Interval 3.3 to 15.8
|
9.7 percentage of participants
Interval 4.2 to 17.9
|
12.5 percentage of participants
Interval 0.5 to 44.5
|
5.7 percentage of participants
Interval 1.8 to 12.9
|
5.9 percentage of participants
Interval 1.0 to 17.4
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: all enrolled participants
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
25th percentile
|
58.6 weeks
Interval 48.1 to 84.0
|
NA weeks
Interval 117.6 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
165.6 weeks
Interval 43.0 to
Not estimable as the upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 4.4 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 58.6 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
98.9 weeks
Interval 47.6 to
Not estimable as the upper limit for the survival function at all weeks is above 75%
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
1st percentile
|
1.0 weeks
Interval 0.0 to 4.1
|
3.1 weeks
Interval 3.1 to 28.9
|
4.4 weeks
Interval 4.4 to 9.4
|
4.4 weeks
Interval 4.4 to 4.4
|
0.1 weeks
Interval 0.1 to 3.7
|
2.4 weeks
Interval 2.4 to 5.1
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
5th percentile
|
8.4 weeks
Interval 4.1 to 18.9
|
33.4 weeks
Interval 3.1 to 59.0
|
36.0 weeks
Interval 4.4 to 38.6
|
4.4 weeks
Interval 4.4 to
Not estimable as the upper limit for the survival function at all weeks is above 95%
|
4.1 weeks
Interval 0.1 to 29.7
|
5.1 weeks
Interval 2.4 to 48.6
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
10th percentile
|
25.3 weeks
Interval 10.6 to 34.3
|
59.0 weeks
Interval 15.0 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
38.6 weeks
Interval 6.4 to 44.6
|
4.4 weeks
Interval 4.4 to
Not estimable as the upper limit for the survival function at all weeks is above 90%
|
29.7 weeks
Interval 3.1 to 61.4
|
47.6 weeks
Interval 2.4 to 55.0
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
50th percentile
|
NA weeks
Interval 120.7 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Interval 165.6 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Interval 4.4 to
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 50%
|
NA weeks
Interval 98.9 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 50%
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: all enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Treatment Modification or Discontinuation by Week 48
|
19.9 percentage of participants
Interval 15.5 to 24.7
|
6.8 percentage of participants
Interval 2.5 to 14.0
|
19.4 percentage of participants
Interval 11.2 to 29.3
|
12.5 percentage of participants
Interval 0.5 to 44.5
|
14.3 percentage of participants
Interval 7.3 to 23.6
|
11.8 percentage of participants
Interval 3.6 to 25.1
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: all enrolled participants
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity
10th percentile
|
NA weeks
Interval 106.1 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 41.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 134.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 3.1 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity
1st percentile
|
2.1 weeks
Interval 0.4 to 32.3
|
15.0 weeks
Interval 15.0 to 49.1
|
6.4 weeks
Interval 6.4 to 134.0
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
0.1 weeks
Interval 0.1 to 3.7
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity
5th percentile
|
106.1 weeks
Interval 32.3 to
Not estimable as the upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 15.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
134.0 weeks
Interval 6.4 to
Not estimable as the upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 0.1 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: all enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48
|
3.2 percentage of participants
Interval 1.6 to 5.8
|
2.7 percentage of participants
Interval 0.5 to 8.6
|
1.4 percentage of participants
Interval 0.1 to 6.7
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
4.3 percentage of participants
Interval 1.1 to 11.0
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: all enrolled participants
Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)
1st percentile
|
NA weeks
Interval 9.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
25.0 weeks
Interval 25.0 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
13.0 weeks
Interval 13.0 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
—
|
|
Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)
5th percentile
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 25.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 13.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: all enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
|
0.7 percentage of participants
Interval 0.1 to 2.4
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
1.4 percentage of participants
Interval 0.1 to 6.7
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
3.0 percentage of participants
Interval 0.2 to 13.6
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: all enrolled participants
Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time to First Dose Modification Due to Grade 3 or 4 Toxicity
1st percentile
|
45.7 weeks
Interval 5.9 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
63.3 weeks
Interval 63.3 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 99%
|
—
|
|
Time to First Dose Modification Due to Grade 3 or 4 Toxicity
5th percentile
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 63.3 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
—
|
SECONDARY outcome
Timeframe: From study entry to week 48Population: all enrolled participants
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48
|
1.0 percentage of participants
Interval 0.3 to 2.8
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48, and 72Population: all enrolled participants with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in CD4+ T-cell Count
Change from baseline at week 24
|
39 cells/mm^3
Standard Deviation 105
|
109 cells/mm^3
Standard Deviation 133
|
116 cells/mm^3
Standard Deviation 130
|
142 cells/mm^3
Standard Deviation 99
|
100 cells/mm^3
Standard Deviation 121
|
90 cells/mm^3
Standard Deviation 131
|
—
|
|
Change From Baseline in CD4+ T-cell Count
Change from baseline at week 48
|
65 cells/mm^3
Standard Deviation 138
|
157 cells/mm^3
Standard Deviation 162
|
158 cells/mm^3
Standard Deviation 172
|
86 cells/mm^3
Standard Deviation 166
|
160 cells/mm^3
Standard Deviation 140
|
135 cells/mm^3
Standard Deviation 214
|
—
|
|
Change From Baseline in CD4+ T-cell Count
Change from baseline at week 72
|
87 cells/mm^3
Standard Deviation 165
|
182 cells/mm^3
Standard Deviation 153
|
197 cells/mm^3
Standard Deviation 199
|
238 cells/mm^3
Standard Deviation 86
|
185 cells/mm^3
Standard Deviation 151
|
165 cells/mm^3
Standard Deviation 270
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48 and 72Population: all enrolled participants with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of Total Cholesterol
Change from baseline at week 48
|
4.4 mg/dL
Standard Deviation 36.0
|
19.7 mg/dL
Standard Deviation 41.1
|
40.4 mg/dL
Standard Deviation 46.9
|
9.9 mg/dL
Standard Deviation 21.6
|
20.0 mg/dL
Standard Deviation 34.6
|
19.1 mg/dL
Standard Deviation 32.0
|
—
|
|
Change From Baseline in Fasting Values of Total Cholesterol
Change from baseline at week 24
|
5.7 mg/dL
Standard Deviation 33.0
|
16.7 mg/dL
Standard Deviation 41.8
|
32.5 mg/dL
Standard Deviation 43.3
|
12.4 mg/dL
Standard Deviation 27.5
|
16.5 mg/dL
Standard Deviation 36.5
|
7.9 mg/dL
Standard Deviation 43.5
|
—
|
|
Change From Baseline in Fasting Values of Total Cholesterol
Change from baseline at week 72
|
7.6 mg/dL
Standard Deviation 33.4
|
22.6 mg/dL
Standard Deviation 47.8
|
40.4 mg/dL
Standard Deviation 51.0
|
28.2 mg/dL
Standard Deviation 42.9
|
22.1 mg/dL
Standard Deviation 35.5
|
24.5 mg/dL
Standard Deviation 33.9
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48 and 72Population: all enrolled participants with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)\]
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
Change from baseline at week 24
|
2.8 mg/dL
Standard Deviation 14.7
|
3.2 mg/dL
Standard Deviation 11.7
|
11.4 mg/dL
Standard Deviation 16.8
|
2.1 mg/dL
Standard Deviation 4.3
|
1.0 mg/dL
Standard Deviation 13.2
|
-2.2 mg/dL
Standard Deviation 11.3
|
—
|
|
Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
Change from baseline at week 48
|
3.5 mg/dL
Standard Deviation 13.9
|
5.3 mg/dL
Standard Deviation 10.3
|
13.4 mg/dL
Standard Deviation 13.8
|
3.8 mg/dL
Standard Deviation 2.9
|
2.3 mg/dL
Standard Deviation 12.2
|
1.8 mg/dL
Standard Deviation 12.2
|
—
|
|
Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
Change from baseline at week 72
|
4.7 mg/dL
Standard Deviation 14.1
|
4.4 mg/dL
Standard Deviation 11.4
|
15.7 mg/dL
Standard Deviation 15.1
|
4.6 mg/dL
Standard Deviation 3.6
|
5.8 mg/dL
Standard Deviation 13.2
|
3.4 mg/dL
Standard Deviation 12.8
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48 and 72Population: all enrolled participants with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
Change from baseline at week 48
|
3.4 mg/dL
Standard Deviation 28.5
|
16.3 mg/dL
Standard Deviation 32.8
|
28.2 mg/dL
Standard Deviation 38.1
|
0.3 mg/dL
Standard Deviation 17.0
|
15.3 mg/dL
Standard Deviation 25.7
|
14.4 mg/dL
Standard Deviation 25.2
|
—
|
|
Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
Change from baseline at week 72
|
3.9 mg/dL
Standard Deviation 26.6
|
22.4 mg/dL
Standard Deviation 38.6
|
27.8 mg/dL
Standard Deviation 40.1
|
16.6 mg/dL
Standard Deviation 37.2
|
13.6 mg/dL
Standard Deviation 25.8
|
19.7 mg/dL
Standard Deviation 27.4
|
—
|
|
Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
Change from baseline at week 24
|
1.3 mg/dL
Standard Deviation 25.2
|
13.3 mg/dL
Standard Deviation 34.4
|
21.5 mg/dL
Standard Deviation 31.6
|
-0.5 mg/dL
Standard Deviation 11.3
|
12.2 mg/dL
Standard Deviation 25.4
|
9.9 mg/dL
Standard Deviation 26.9
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48 and 72Population: all enrolled participants with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of Triglycerides
Change from baseline at week 24
|
15.4 mg/dL
Standard Deviation 75.7
|
-3.6 mg/dL
Standard Deviation 84.9
|
27.6 mg/dL
Standard Deviation 112.5
|
36.0 mg/dL
Standard Deviation 48.1
|
15.4 mg/dL
Standard Deviation 84.4
|
28.9 mg/dL
Standard Deviation 65.5
|
—
|
|
Change From Baseline in Fasting Values of Triglycerides
Change from baseline at week 48
|
12.2 mg/dL
Standard Deviation 70.8
|
-11.5 mg/dL
Standard Deviation 136.7
|
19.9 mg/dL
Standard Deviation 84.1
|
22.2 mg/dL
Standard Deviation 57.2
|
9.9 mg/dL
Standard Deviation 65.9
|
24.4 mg/dL
Standard Deviation 90.1
|
—
|
|
Change From Baseline in Fasting Values of Triglycerides
Change from baseline at week 72
|
17.5 mg/dL
Standard Deviation 79.1
|
-31.3 mg/dL
Standard Deviation 122.3
|
18.9 mg/dL
Standard Deviation 99.4
|
20.7 mg/dL
Standard Deviation 56.3
|
11.8 mg/dL
Standard Deviation 83.9
|
6.7 mg/dL
Standard Deviation 71.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48 and 72Population: all enrolled participants with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)
Outcome measures
| Measure |
Overall Study
n=287 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=74 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=72 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=8 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=70 Participants
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=34 Participants
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of Glucose
Change from baseline at week 24
|
1.9 mg/dL
Standard Deviation 25.0
|
8.8 mg/dL
Standard Deviation 18.9
|
6.1 mg/dL
Standard Deviation 22.3
|
6.6 mg/dL
Standard Deviation 8.3
|
2.1 mg/dL
Standard Deviation 19.9
|
3.2 mg/dL
Standard Deviation 19.1
|
—
|
|
Change From Baseline in Fasting Values of Glucose
Change from baseline at week 72
|
3.0 mg/dL
Standard Deviation 29.7
|
6.8 mg/dL
Standard Deviation 23.8
|
-5.2 mg/dL
Standard Deviation 79.1
|
4.3 mg/dL
Standard Deviation 7.6
|
-0.9 mg/dL
Standard Deviation 17.9
|
7.8 mg/dL
Standard Deviation 13.7
|
—
|
|
Change From Baseline in Fasting Values of Glucose
Change from baseline at week 48
|
2.1 mg/dL
Standard Deviation 19.8
|
9.3 mg/dL
Standard Deviation 28.5
|
6.2 mg/dL
Standard Deviation 20.1
|
1.7 mg/dL
Standard Deviation 6.9
|
3.0 mg/dL
Standard Deviation 16.7
|
4.2 mg/dL
Standard Deviation 13.7
|
—
|
SECONDARY outcome
Timeframe: 48 weeks after the date of entryPopulation: All participants randomized to either CPI+SOC or SOC
The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive). The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA\>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA \>200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]
|
0.66 proportion of participants
Interval 0.6 to 0.72
|
0.62 proportion of participants
Interval 0.56 to 0.68
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeks after the date of entryPopulation: All participants randomized to either CPI+SOC or SOC
The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive). The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA\>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA \>200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]
|
0.68 proportion of participants
Interval 0.62 to 0.73
|
0.61 proportion of participants
Interval 0.55 to 0.67
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 72 weeks after the date of entryPopulation: All participants randomized to either CPI+SOC or SOC with results expected at week 72
The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive). The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA\>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA \>200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL.
Outcome measures
| Measure |
Overall Study
n=210 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=217 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]
|
0.69 proportion of participants
Interval 0.62 to 0.75
|
0.62 proportion of participants
Interval 0.55 to 0.68
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-upPopulation: All participants randomized to either CPI+SOC or SOC
All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Number of Weeks of Follow-up [CPI+SOC v SOC]
|
72 weeks
Interval 72.0 to 108.0
|
72 weeks
Interval 72.0 to 108.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure \[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
1st percentile
|
24 weeks
Interval 24.0 to 24.0
|
24 weeks
Interval 24.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
5th percentile
|
24 weeks
Interval 24.0 to 24.0
|
24 weeks
Interval 24.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
10th percentile
|
24 weeks
Interval 24.0 to 24.0
|
24 weeks
Interval 24.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
25th percentile
|
60 weeks
Interval 48.0 to
Not estimable as the upper limit for survival function at all weeks is above 75%
|
24 weeks
Interval 24.0 to 48.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
50th percentile
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for survival function at all weeks is above 50%
|
NA weeks
Interval 144.0 to
Not estimable as the estimate and upper limit for survival function at all weeks is above 50%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure \[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
|
66 Participants
|
89 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 24 to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure \[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]
|
24.9 percentage of participants
Interval 19.6 to 30.4
|
32.2 percentage of participants
Interval 26.6 to 37.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure \[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
1st percentile
|
24 weeks
Interval 24.0 to 24.0
|
24 weeks
Interval 24.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
5th percentile
|
24 weeks
Interval 24.0 to 48.0
|
24 weeks
Interval 24.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
10th percentile
|
NA weeks
Interval 24.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
48 weeks
Interval 24.0 to 144.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
25th percentile
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 144.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure\[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
|
20 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From week 24 to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure\[specimens on separate dates\] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7\*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]
|
7.8 percentage of participants
Interval 4.9 to 11.7
|
12.1 percentage of participants
Interval 8.4 to 16.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to Death [CPI+SOC v SOC]
1st percentile
|
11.3 weeks
Interval 3.1 to 27.4
|
15.9 weeks
Interval 2.4 to 51.4
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to Death [CPI+SOC v SOC]
5th percentile
|
NA weeks
Interval 27.4 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
82.1 weeks
Interval 51.4 to
Not estimable as the upper limit for the survival function at all weeks is above 95%
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to Death [CPI+SOC v SOC]
10th percentile
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 90%
|
NA weeks
Interval 110.1 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 90%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]
|
3.9 percentage of participants
Interval 2.0 to 6.8
|
1.5 percentage of participants
Interval 0.5 to 3.6
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
1st percentile
|
4.0 weeks
Interval 3.1 to 4.0
|
4.0 weeks
Interval 2.4 to 12.0
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
5th percentile
|
27.6 weeks
Interval 4.0 to 42.9
|
42.3 weeks
Interval 12.4 to 58.9
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
10th percentile
|
60.6 weeks
Interval 36.0 to 84.0
|
77.9 weeks
Interval 48.0 to 91.6
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
25th percentile
|
NA weeks
Interval 142.4 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 112.7 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]
|
8.2 percentage of participants
Interval 5.3 to 12.0
|
6.5 percentage of participants
Interval 3.9 to 9.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
1st percentile
|
2.3 weeks
Interval 2.0 to 4.0
|
2.3 weeks
Interval 1.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
5th percentile
|
11.3 weeks
Interval 4.0 to 25.1
|
20.3 weeks
Interval 8.7 to 32.4
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
10th percentile
|
44.6 weeks
Interval 20.6 to 90.7
|
45.3 weeks
Interval 25.6 to 77.9
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
25th percentile
|
168.9 weeks
Interval 119.6 to
Not estimable as the upper limit for the survival function at all weeks is above 75%
|
NA weeks
Interval 107.3 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 75%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]
|
10.6 percentage of participants
Interval 7.2 to 14.7
|
10.6 percentage of participants
Interval 7.3 to 14.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
1st percentile
|
1.0 weeks
Interval 0.0 to 3.7
|
2.4 weeks
Interval 0.1 to 5.9
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
5th percentile
|
5.1 weeks
Interval 3.7 to 9.3
|
22.3 weeks
Interval 9.0 to 31.9
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
10th percentile
|
23.6 weeks
Interval 6.9 to 36.0
|
38.9 weeks
Interval 26.0 to 47.0
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
25th percentile
|
84.0 weeks
Interval 48.7 to 148.3
|
111.1 weeks
Interval 72.4 to
Not estimable as the upper limit for the survival function at all weeks is above 75%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]
|
19.1 percentage of participants
Interval 14.5 to 24.1
|
13.6 percentage of participants
Interval 9.8 to 18.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]
1st percentile
|
3.1 weeks
Interval 0.4 to 5.0
|
9.0 weeks
Interval 0.1 to 41.0
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]
5th percentile
|
NA weeks
Interval 5.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 41.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]
|
2.8 percentage of participants
Interval 1.2 to 5.3
|
2.3 percentage of participants
Interval 1.0 to 4.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]
1st percentile
|
NA weeks
Interval 9.0 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 99%
|
25.0 weeks
Interval 13.0 to
Not estimable as the upper limit for the survival function at all weeks is above 99%
|
—
|
—
|
—
|
—
|
—
|
|
Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]
5th percentile
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]
|
0.4 percentage of participants
Interval 0.03 to 2.1
|
1.1 percentage of participants
Interval 0.3 to 3.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeksPopulation: All participants randomized to either CPI+SOC or SOC
Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]
1st percentile
|
45.7 weeks
Interval 5.9 to
Not estimable as the upper limit for the survival function at all weeks is above 95%
|
NA weeks
Interval 63.3 to
Not estimable as the estimate and upper limit for the survival function at all weeks is above 95%
|
—
|
—
|
—
|
—
|
—
|
|
Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]
5th percentile
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
NA weeks
Not estimable as the estimate, lower limit and upper limit for the survival function at all weeks is above 95%
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to Week 48Population: All participants randomized to either CPI+SOC or SOC
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]
|
1.2 percentage of participants
Interval 0.3 to 3.2
|
0 percentage of participants
Not estimated due to lack of events in group by week 48
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48, and 72Population: All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]
Change from baseline at week 24
|
72 cells/mm^3
Standard Deviation 125
|
74 cells/mm^3
Standard Deviation 118
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]
Change from baseline at week 48
|
112 cells/mm^3
Standard Deviation 162
|
107 cells/mm^3
Standard Deviation 157
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]
Change from baseline at week 72
|
145 cells/mm^3
Standard Deviation 195
|
134 cells/mm^3
Standard Deviation 170
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48, and 72Population: All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]
Change from baseline at week 24
|
10.1 mg/dL
Standard Deviation 37.4
|
14.4 mg/dL
Standard Deviation 38.8
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]
Change from baseline at week 48
|
15.1 mg/dL
Standard Deviation 39.1
|
14.1 mg/dL
Standard Deviation 40.6
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]
Change from baseline at week 72
|
17.4 mg/dL
Standard Deviation 41.8
|
18.7 mg/dL
Standard Deviation 40.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48, and 72Population: All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Change from baseline at week 24
|
2.9 mg/dL
Standard Deviation 13.0
|
3.6 mg/dL
Standard Deviation 16.1
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Change from baseline at week 48
|
5.6 mg/dL
Standard Deviation 12.6
|
3.7 mg/dL
Standard Deviation 14.3
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Change from baseline at week 72
|
6.0 mg/dL
Standard Deviation 13.7
|
6.6 mg/dL
Standard Deviation 14.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48, and 72Population: All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Change from baseline at week 24
|
5.5 mg/dL
Standard Deviation 29.9
|
9.5 mg/dL
Standard Deviation 27.0
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Change from baseline at week 48
|
12.0 mg/dL
Standard Deviation 31.9
|
10.1 mg/dL
Standard Deviation 30.0
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Change from baseline at week 72
|
11.9 mg/dL
Standard Deviation 33.3
|
12.8 mg/dL
Standard Deviation 31.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48, and 72Population: All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]
Change from baseline at week 24
|
15.3 mg/dL
Standard Deviation 86.9
|
18.7 mg/dL
Standard Deviation 80.4
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]
Change from baseline at week 48
|
2.2 mg/dL
Standard Deviation 89.4
|
19.6 mg/dL
Standard Deviation 81.1
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]
Change from baseline at week 72
|
13.7 mg/dL
Standard Deviation 103.4
|
7.1 mg/dL
Standard Deviation 73.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 24, 48, and 72Population: All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.
Outcome measures
| Measure |
Overall Study
n=257 Participants
Entire enrolled population spanning all arms and interventions.
|
Experimental: Cohort A
n=264 Participants
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
Change from baseline at week 48
|
3.6 mg/dL
Standard Deviation 16.5
|
5.1 mg/dL
Standard Deviation 23.1
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
Change from baseline at week 24
|
3.7 mg/dL
Standard Deviation 26.1
|
3.7 mg/dL
Standard Deviation 18.2
|
—
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
Change from baseline at week 72
|
3.6 mg/dL
Standard Deviation 29.0
|
1.5 mg/dL
Standard Deviation 45.9
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Experimental: Cohort A
Serious events: 61 serious events
Other events: 283 other events
Deaths: 18 deaths
Experimental: Sub-cohort B1
Serious events: 8 serious events
Other events: 72 other events
Deaths: 1 deaths
Experimental: Sub-cohort B2
Serious events: 13 serious events
Other events: 69 other events
Deaths: 2 deaths
Experimental: Sub-cohort B3
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Experimental: Cohort C
Serious events: 9 serious events
Other events: 69 other events
Deaths: 1 deaths
Experimental: Cohort D
Serious events: 6 serious events
Other events: 33 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental: Cohort A
n=287 participants at risk
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=74 participants at risk
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=72 participants at risk
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=8 participants at risk
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=70 participants at risk
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
n=34 participants at risk
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Eye disorders
Ulcerative keratitis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
General disorders
Death
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Immune system disorders
Immunosuppression
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Amoebiasis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Appendicitis perforated
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Atypical pneumonia
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Bacteraemia
|
1.4%
4/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Dengue fever
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Disseminated tuberculosis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Encephalitis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Gastroenteritis
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
HIV-associated neurocognitive disorder
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Herpes zoster
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Leptospirosis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Malaria
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Meningitis
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Meningitis cryptococcal
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Meningitis pneumococcal
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Neurocryptococcosis
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Oesophageal candidiasis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Otitis media acute
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Peritonitis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Pneumonia
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Pneumonia bacterial
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Pneumonia haemophilus
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Pyelonephritis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Scrub typhus
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Sepsis
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Septic shock
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Urinary tract infection
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Wound infection
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Weight decreased
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
White blood cell count decreased
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Metabolism and nutrition disorders
Cachexia
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Dizziness
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Dystonia
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Facial paralysis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Seizure
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Syncope
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Tension headache
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.7%
5/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Renal and urinary disorders
Renal impairment
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic interstitial pneumonia
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Vascular disorders
Jugular vein thrombosis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
Other adverse events
| Measure |
Experimental: Cohort A
n=287 participants at risk
Under Protocol version 1.0:
No resistance to NRTIs, PIs, or NNRTI
• Continue current second-line regimen; NRTIs could be modified
Changed under LOA#2 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure • Continue second-line regimen which may include LPV/RTV; NRTIs could be modified
Changed under LOA#3 to:
No LPV/RTV resistance and susceptible to at least one NRTI, regardless of NNRTI resistance or prior RAL exposure
• Continue PI backbone; NRTIs could be modified. If on a RAL-containing regimen, RAL must be discontinued.
|
Experimental: Sub-cohort B1
n=74 participants at risk
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • Best available NRTIs, RAL, \& DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• Best available NRTIs, RAL, \& DRV/RTV
|
Experimental: Sub-cohort B2
n=72 participants at risk
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and without active hepatitis B infection at screening • ETR, RAL, and DRV/RTV
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (and without active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (and without active hepatitis B infection at screening)
• ETR, RAL, and DRV/RTV
|
Experimental: Sub-cohort B3
n=8 participants at risk
Under Protocol version 1.0:
Susceptible to DRV/RTV and ETR with or without resistance to NRTIs (and may have resistance to other PIs) and with active hepatitis B infection at screening • RAL, DRV/RTV, and FTC/TDF or TDF+3TC
Changed under LOA#2 to:
Resistance to LPV/RTV but susceptible to DRV/RTV and ETR and with no prior RAL exposure and regardless of NRTI resistance (with active hepatitis B infection at screening) OR Resistance to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and ETR and with no prior RAL exposure (with active hepatitis B infection at screening)
• RAL, DRV/RTV, and FTC/TDF or TDF+3TC
|
Experimental: Cohort C
n=70 participants at risk
Under Protocol version 1.0:
Resistance to NRTIs and ETR or resistance to ETR alone (and may have resistance to PIs other than DRV) • Best available NRTIs, RAL, and DRV/RTV
Changed under LOA#2:
Resistance to LPV/RTV and ETR but susceptible to DRV/RTV and with no prior RAL exposure and regardless of NRTI resistance OR Resistance to ETR and to all NRTIs (i.e. susceptible to none) but susceptible to DRV/RTV and with no prior RAL exposure
• Best available NRTIs, RAL, and DRV/RTV
|
Experimental: Cohort D
n=34 participants at risk
Under Protocol version 1.0:
Multiple NRTI resistance and/or DRV/RTV resistance or prior RAL exposure:
• Best available regimen, including study-provided and any locally available drugs
Changed under LOA#2:
Not eligible for Cohort A, B, or C:
• Best available regimen, including study-provided and any locally available drugs
Updated under protocol v2.0:
• Best available ART regimen, including study-provided and any locally available non-experimental drugs
|
|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Eye disorders
Eye pain
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Abdominal pain
|
6.3%
18/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.1%
3/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
6.9%
5/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
7/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.2%
3/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
22/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.1%
6/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
9.7%
7/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Peptic ulcer
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
23/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.2%
3/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.3%
3/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
General disorders
Chest pain
|
3.5%
10/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
General disorders
Chills
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
General disorders
Fatigue
|
1.7%
5/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
General disorders
Oedema peripheral
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
General disorders
Pain
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.1%
3/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
General disorders
Pyrexia
|
18.5%
53/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
10.8%
8/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
11.1%
8/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.0%
2/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
11.4%
8/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
26.5%
9/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Acarodermatitis
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Acute sinusitis
|
2.1%
6/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Bacteraemia
|
1.4%
4/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Bacterial vaginosis
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Body tinea
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Chronic hepatitis B
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Gastroenteritis
|
1.7%
5/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Helminthic infection
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Herpes zoster
|
3.1%
9/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.1%
3/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.2%
3/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.7%
4/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Influenza
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Nasopharyngitis
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Oral candidiasis
|
6.6%
19/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Pneumonia bacterial
|
3.8%
11/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Purulent discharge
|
1.4%
4/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
19/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
9.7%
7/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.0%
2/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.6%
6/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Urinary tract infection
|
5.2%
15/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
9.5%
7/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.4%
7/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
41/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
16.2%
12/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.3%
6/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
15.7%
11/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
17.6%
6/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Aspartate aminotransferase increased
|
23.7%
68/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
18.9%
14/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
18.1%
13/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.0%
2/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.7%
18/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
23.5%
8/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood alkaline phosphatase abnormal
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood alkaline phosphatase increased
|
23.7%
68/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
27.0%
20/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
22.2%
16/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
37.1%
26/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
20.6%
7/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood bicarbonate decreased
|
32.8%
94/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
29.7%
22/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
31.9%
23/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
37.5%
3/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
38.6%
27/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
41.2%
14/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood bilirubin increased
|
36.9%
106/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.7%
19/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
16.7%
12/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
37.5%
3/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
31.4%
22/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
17.6%
6/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood cholesterol increased
|
22.6%
65/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
55.4%
41/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
55.6%
40/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
37.5%
3/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
44.3%
31/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
47.1%
16/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood creatinine increased
|
12.9%
37/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
13.5%
10/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
11.1%
8/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.9%
9/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
11.8%
4/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood glucose decreased
|
11.1%
32/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.1%
6/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
13.9%
10/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
10.0%
7/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood glucose increased
|
25.1%
72/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
20.3%
15/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
30.6%
22/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
30.0%
21/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
32.4%
11/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood phosphorus decreased
|
26.1%
75/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
33.8%
25/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
29.2%
21/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
28.6%
20/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
35.3%
12/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood potassium decreased
|
11.8%
34/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
16.2%
12/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.7%
4/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
14.7%
5/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood potassium increased
|
4.9%
14/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
7.1%
5/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood pressure increased
|
2.1%
6/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood sodium decreased
|
50.5%
145/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
59.5%
44/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
44.4%
32/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
100.0%
8/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
60.0%
42/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
47.1%
16/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood sodium increased
|
14.6%
42/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
9.7%
7/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.7%
4/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Blood triglycerides increased
|
2.8%
8/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.1%
6/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
6.9%
5/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.3%
3/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Haemoglobin decreased
|
13.9%
40/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
10.8%
8/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
9/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.0%
2/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.6%
6/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
20.6%
7/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Low density lipoprotein increased
|
22.6%
65/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
56.8%
42/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
51.4%
37/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.0%
2/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
45.7%
32/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
47.1%
16/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Neutrophil count decreased
|
22.3%
64/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
28.4%
21/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
27.8%
20/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.0%
2/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
21.4%
15/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
26.5%
9/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Platelet count decreased
|
8.0%
23/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
6.8%
5/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
11.4%
8/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
Weight decreased
|
8.7%
25/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.2%
3/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Investigations
White blood cell count decreased
|
7.7%
22/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
14.9%
11/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
6.9%
5/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
10.0%
7/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
14.7%
5/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
17/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.1%
3/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
8/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.2%
3/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
5/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
6.9%
5/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
6/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
7/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Headache
|
9.4%
27/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.1%
6/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
13.9%
10/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.0%
2/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.3%
3/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.1%
3/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Nervous system disorders
Seizure
|
1.7%
5/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Renal and urinary disorders
Dysuria
|
4.5%
13/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
6.8%
5/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Renal and urinary disorders
Pollakiuria
|
1.7%
5/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.35%
1/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.7%
5/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
6.8%
5/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.7%
5/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
50/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
9.5%
7/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
19.4%
14/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
25.0%
2/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.9%
9/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
23.5%
8/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
14/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
1/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.8%
8/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.6%
4/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
14.7%
5/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
5.9%
17/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.3%
18/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
11.1%
8/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
7.1%
5/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.1%
9/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.9%
2/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
3/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
9/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.2%
9/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.2%
3/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.3%
3/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.70%
2/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.4%
4/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
4.2%
3/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
5.9%
2/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.8%
11/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.8%
2/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
11.8%
4/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
12.5%
1/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
|
Vascular disorders
Hypertension
|
2.8%
8/287 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
2.7%
2/74 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/72 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
0.00%
0/8 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
1.4%
1/70 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
8.8%
3/34 • From enrollment to the end of step 1/2 follow up. Participants were followed in Steps 1 and 2 until 48 weeks after the last participant was enrolled to Step 1. Median follow-up time was 72 weeks, maximum of 204 weeks.
Version 2.0 of the DAIDS EAE Manual was used for this study. At entry, signs, symptoms and laboratory values regardless of grade that occurred \<30 days before entry were reported. Post-entry, signs/symptoms and laboratory values grade ≥3, or caused a change in treatment/ART regardless of grade, were reported. Diagnoses identified on the study-specific list, or caused a change in treatment, were recorded at all visits. Used DAIDS AE Grading Table, Version 1.0, December 2004 (clarified AUG09)
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place