Trial Outcomes & Findings for Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults (NCT NCT00118898)
NCT ID: NCT00118898
Last Updated: 2018-10-12
Results Overview
Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or \>=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1864 participants
Primary outcome timeframe
Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Results posted on
2018-10-12
Participant Flow
Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between September 21, 2005 (date first subject was randomized) and November 20, 2007 (date last subject was randomized).
1864 were randomized. Results reported for 1857 eligible participants; 7 were subsequently found ineligible and excluded from all analyses.
Participant milestones
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
464
|
465
|
465
|
463
|
|
Overall Study
Initiated Treatment
|
461
|
461
|
464
|
462
|
|
Overall Study
COMPLETED
|
343
|
324
|
342
|
322
|
|
Overall Study
NOT COMPLETED
|
121
|
141
|
123
|
141
|
Reasons for withdrawal
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Overall Study
Death
|
6
|
11
|
6
|
8
|
|
Overall Study
Lost to Follow-up
|
26
|
34
|
33
|
33
|
|
Overall Study
Withdrawal by Subject
|
10
|
5
|
8
|
8
|
|
Overall Study
Site Closure
|
33
|
31
|
28
|
37
|
|
Overall Study
Severe debilitation
|
1
|
4
|
6
|
4
|
|
Overall Study
Not compliant with requirements
|
11
|
13
|
11
|
11
|
|
Overall Study
Not able to get to clinic
|
34
|
43
|
31
|
40
|
Baseline Characteristics
Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
Baseline characteristics by cohort
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
Total
n=1857 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
461 Participants
n=5 Participants
|
454 Participants
n=7 Participants
|
461 Participants
n=5 Participants
|
458 Participants
n=4 Participants
|
1834 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
38.9 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
38.4 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
322 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
393 Participants
n=5 Participants
|
367 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
388 Participants
n=4 Participants
|
1535 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
197 participants
n=5 Participants
|
174 participants
n=7 Participants
|
186 participants
n=5 Participants
|
189 participants
n=4 Participants
|
746 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black Non-Hispanic
|
151 participants
n=5 Participants
|
164 participants
n=7 Participants
|
147 participants
n=5 Participants
|
153 participants
n=4 Participants
|
615 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic (Regardless of Race)
|
104 participants
n=5 Participants
|
106 participants
n=7 Participants
|
111 participants
n=5 Participants
|
108 participants
n=4 Participants
|
429 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian, Pacific Islander
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
7 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native American, Alaskan Native
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
451 participants
n=5 Participants
|
452 participants
n=7 Participants
|
452 participants
n=5 Participants
|
450 participants
n=4 Participants
|
1805 participants
n=21 Participants
|
|
Region of Enrollment
Puerto Rico
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
13 participants
n=4 Participants
|
52 participants
n=21 Participants
|
|
Baseline HIV-1 RNA
|
4.7 log10 copies/mL
STANDARD_DEVIATION 0.7 • n=5 Participants
|
4.7 log10 copies/mL
STANDARD_DEVIATION 0.7 • n=7 Participants
|
4.7 log10 copies/mL
STANDARD_DEVIATION 0.7 • n=5 Participants
|
4.7 log10 copies/mL
STANDARD_DEVIATION 0.7 • n=4 Participants
|
4.7 log10 copies/mL
STANDARD_DEVIATION 0.7 • n=21 Participants
|
|
Screening HIV-1 RNA
<100,000 copies/mL
|
265 participants
n=5 Participants
|
266 participants
n=7 Participants
|
265 participants
n=5 Participants
|
264 participants
n=4 Participants
|
1060 participants
n=21 Participants
|
|
Screening HIV-1 RNA
>=100,000 copies/mL
|
199 participants
n=5 Participants
|
199 participants
n=7 Participants
|
200 participants
n=5 Participants
|
199 participants
n=4 Participants
|
797 participants
n=21 Participants
|
|
Baseline CD4+ count
|
233.5 cells/mm3
n=5 Participants
|
225 cells/mm3
n=7 Participants
|
224 cells/mm3
n=5 Participants
|
236 cells/mm3
n=4 Participants
|
229.5 cells/mm3
n=21 Participants
|
PRIMARY outcome
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for detailsPopulation: Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.
Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or \>=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Time From Randomization to Virologic Failure
5th percentile time to virologic failure
|
36 Weeks
Interval 24.0 to 60.0
|
24 Weeks
Interval 16.0 to 24.0
|
24 Weeks
Interval 24.0 to 48.0
|
24 Weeks
Interval 16.0 to 24.0
|
|
Time From Randomization to Virologic Failure
10th percentile time to virologic failure
|
96 Weeks
Interval 72.0 to 132.0
|
36 Weeks
Interval 24.0 to 60.0
|
84 Weeks
Interval 48.0 to 156.0
|
36 Weeks
Interval 24.0 to 60.0
|
PRIMARY outcome
Timeframe: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.Population: As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Time From Treatment Dispensation to a Grade 3/4 Safety Event
5th percentile time to a grade 3/4 safety event
|
2.6 Weeks
Interval 1.6 to 4.3
|
1.3 Weeks
Interval 1.0 to 1.3
|
3.0 Weeks
Interval 1.3 to 4.9
|
1.3 Weeks
Interval 1.0 to 1.7
|
|
Time From Treatment Dispensation to a Grade 3/4 Safety Event
10th percentile time to a grade 3/4 safety event
|
7.9 Weeks
Interval 4.3 to 13.0
|
2.0 Weeks
Interval 1.3 to 3.9
|
8.1 Weeks
Interval 5.1 to 17.9
|
3.9 Weeks
Interval 1.9 to 7.1
|
|
Time From Treatment Dispensation to a Grade 3/4 Safety Event
25th percentile time to a grade 3/4 safety event
|
59.3 Weeks
Interval 41.7 to 91.7
|
16.0 Weeks
Interval 8.3 to 22.0
|
81.4 Weeks
Interval 47.9 to 111.3
|
44.4 Weeks
Interval 24.3 to 52.1
|
PRIMARY outcome
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for detailsPopulation: Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Time From Treatment Dispensation to Treatment Modification
5th percentile time to treatment modification
|
3.4 Weeks
Interval 1.6 to 7.1
|
1.4 Weeks
Interval 1.3 to 1.6
|
7.9 Weeks
Interval 2.1 to 14.0
|
1.6 Weeks
Interval 1.3 to 2.4
|
|
Time From Treatment Dispensation to Treatment Modification
10th percentile time to treatment modification
|
15.0 Weeks
Interval 7.6 to 23.7
|
2.1 Weeks
Interval 1.6 to 4.1
|
24.9 Weeks
Interval 14.4 to 38.1
|
5.0 Weeks
Interval 2.6 to 12.6
|
|
Time From Treatment Dispensation to Treatment Modification
25th percentile time to treatment modification
|
83.7 Weeks
Interval 63.0 to 119.6
|
27.4 Weeks
Interval 21.7 to 34.9
|
108.9 Weeks
Interval 85.1 to 144.1
|
43.6 Weeks
Interval 30.3 to 56.0
|
SECONDARY outcome
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for detailsPopulation: Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks and before 24 weeks or \>=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
5th percentile time to regimen failure
|
4 Weeks
Interval 4.0 to 4.0
|
4 Weeks
Interval 4.0 to 4.0
|
4 Weeks
Interval 4.0 to 16.0
|
4 Weeks
Interval 4.0 to 4.0
|
|
Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
10th percentile time to regimen failure
|
16 Weeks
Interval 4.0 to 16.0
|
4 Weeks
Interval 4.0 to 4.0
|
16 Weeks
Interval 16.0 to 24.0
|
4 Weeks
Interval 4.0 to 16.0
|
|
Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
25th percentile time to regimen failure
|
72 Weeks
Interval 48.0 to 96.0
|
24 Weeks
Interval 16.0 to 36.0
|
84 Weeks
Interval 60.0 to 108.0
|
36 Weeks
Interval 24.0 to 36.0
|
SECONDARY outcome
Timeframe: At Weeks 48 and 96Population: Intention to treat: All participants with RNA data were included, complete-case approach.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Number of Participants with RNA data at Week 48
|
415 Participants
|
400 Participants
|
416 Participants
|
411 Participants
|
|
The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Number with HIV-1 RNA <50 copies/ml at Week 48
|
372 Participants
|
346 Participants
|
348 Participants
|
322 Participants
|
|
The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Number of Participants with RNA data at Week 96
|
379 Participants
|
361 Participants
|
384 Participants
|
374 Participants
|
|
The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Number with HIV-1 RNA <50 copies/ml at Week 96
|
345 Participants
|
328 Participants
|
345 Participants
|
317 Participants
|
SECONDARY outcome
Timeframe: At Weeks 48 and 96Population: Intention to treat: All participants with RNA data were included, complete-case approach.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
Number of Participants with RNA data at Week 48
|
415 Participants
|
400 Participants
|
416 Participants
|
411 Participants
|
|
Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
Number with HIV-1 RNA <200 copies/ml at Week 48
|
398 Participants
|
377 Participants
|
391 Participants
|
372 Participants
|
|
Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
Number of Participants with RNA data at Week 96
|
379 Participants
|
361 Participants
|
384 Participants
|
374 Participants
|
|
Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
Number with HIV-1 RNA <200 copies/ml at Week 96
|
362 Participants
|
342 Participants
|
368 Participants
|
346 Participants
|
SECONDARY outcome
Timeframe: At Weeks 48 and 96Population: Intention to treat: All participants with CD4 data were included, complete-case approach.
Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Change in CD4 Count (Cells/mm3) From Baseline
Week 48
|
163 Cells/mm3
Interval 96.5 to 250.0
|
188 Cells/mm3
Interval 102.5 to 277.5
|
175 Cells/mm3
Interval 108.0 to 290.0
|
177.5 Cells/mm3
Interval 106.0 to 275.5
|
|
Change in CD4 Count (Cells/mm3) From Baseline
Week 96
|
220.5 Cells/mm3
Interval 134.5 to 323.5
|
250.5 Cells/mm3
Interval 158.0 to 364.3
|
251.5 Cells/mm3
Interval 165.5 to 362.5
|
250.3 Cells/mm3
Interval 153.0 to 350.0
|
SECONDARY outcome
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for detailsPopulation: Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.
Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Number of Participants With Virologic Failure and Emergence of Major Resistance
|
27 participants
|
41 participants
|
5 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for detailsPopulation: Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.
AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details. http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.
Death
|
6 Participants
|
11 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.
AIDS-defining illness
|
14 Participants
|
25 Participants
|
20 Participants
|
23 Participants
|
|
Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.
HIV-1 relatated event
|
56 Participants
|
61 Participants
|
57 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: At Weeks 48 and 96Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.
Only fasting results are included. The protocol did not require that samples be collected fasting.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Change in Fasting Total Cholesterol Level From Baseline
Week 48
|
22 mg/dL
Interval 2.0 to 43.0
|
35 mg/dL
Interval 15.5 to 58.0
|
11 mg/dL
Interval -9.0 to 36.0
|
30 mg/dL
Interval 9.0 to 54.0
|
|
Change in Fasting Total Cholesterol Level From Baseline
Week 96
|
23 mg/dL
Interval 2.0 to 41.0
|
33 mg/dL
Interval 10.0 to 60.0
|
14 mg/dL
Interval -6.0 to 39.0
|
25 mg/dL
Interval 7.0 to 50.0
|
SECONDARY outcome
Timeframe: At Weeks 48 and 96Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.
Only fasting results are included. The protocol did not require that samples be collected fasting.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
Week 48
|
8 mg/dL
Interval 3.0 to 15.0
|
10 mg/dL
Interval 4.0 to 18.0
|
5 mg/dL
Interval -2.0 to 10.0
|
8 mg/dL
Interval 1.0 to 16.0
|
|
Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
Week 96
|
9 mg/dL
Interval 2.0 to 16.0
|
11 mg/dL
Interval 3.5 to 18.5
|
4 mg/dL
Interval -1.0 to 11.0
|
7 mg/dL
Interval 1.0 to 15.0
|
SECONDARY outcome
Timeframe: At Weeks 48 and 96Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.
Only fasting results are included. The protocol did not require that samples be collected fasting.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline
Week 96
|
13.5 mg/dL
Interval -5.5 to 31.0
|
18 mg/dL
Interval 0.0 to 45.0
|
10 mg/dL
Interval -9.5 to 34.0
|
18 mg/dL
Interval 2.0 to 43.0
|
|
Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline
Week 48
|
14 mg/dL
Interval -4.5 to 30.5
|
23 mg/dL
Interval 3.0 to 47.0
|
8 mg/dL
Interval -11.0 to 30.0
|
20 mg/dL
Interval -1.0 to 42.0
|
SECONDARY outcome
Timeframe: At Weeks 48 and 96Population: Intention to treat: All participants with fasting lipids data were included, complete-case approach.
Only fasting results are included. The protocol did not require that samples be collected fasting.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Change in Fasting Triglyceride Level From Baseline
Week 48
|
10 mg/dL
Interval -29.0 to 44.0
|
15 mg/dL
Interval -20.0 to 65.0
|
14 mg/dL
Interval -18.0 to 52.0
|
24 mg/dL
Interval -12.0 to 80.0
|
|
Change in Fasting Triglyceride Level From Baseline
Week 96
|
9 mg/dL
Interval -27.0 to 48.0
|
14 mg/dL
Interval -22.0 to 54.0
|
11 mg/dL
Interval -21.0 to 47.0
|
33 mg/dL
Interval -9.0 to 78.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Follow-up time was variable, median follow-up was 138 weeksPopulation: Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.
Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Amount of Study Follow-up
|
141.4 Weeks
Interval 108.0 to 169.0
|
133.3 Weeks
Interval 101.3 to 168.0
|
141.6 Weeks
Interval 105.9 to 168.1
|
137.3 Weeks
Interval 106.0 to 169.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for detailsPopulation: Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks and before 24 weeks or \>=200 copies/mL at or after 24 weeks.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Number of Participants With Virologic Failure
|
57 participants
|
72 participants
|
57 participants
|
83 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At week 48 and 96Population: Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks and before 24 weeks or \>=200 copies/mL at or after 24 weeks.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=465 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=465 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=463 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Cumulative Probability of Not Experiencing Virologic Failure
Week 48
|
94 percentage of participants
Interval 91.0 to 96.0
|
88 percentage of participants
Interval 85.0 to 91.0
|
92 percentage of participants
Interval 89.0 to 94.0
|
88 percentage of participants
Interval 84.0 to 90.0
|
|
Cumulative Probability of Not Experiencing Virologic Failure
Week 96
|
90 percentage of participants
Interval 87.0 to 92.0
|
85 percentage of participants
Interval 82.0 to 88.0
|
89 percentage of participants
Interval 86.0 to 92.0
|
83 percentage of participants
Interval 79.0 to 87.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeksPopulation: As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Number of Participants With a Grade 3/4 Safety Event
|
145 participants
|
182 participants
|
137 participants
|
156 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At week 48 and 96Population: As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
Week 48
|
78 percentage of participants
Interval 73.0 to 81.0
|
64 percentage of participants
Interval 60.0 to 69.0
|
79 percentage of participants
Interval 75.0 to 82.0
|
73 percentage of participants
Interval 68.0 to 77.0
|
|
Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
Week 96
|
70 percentage of participants
Interval 65.0 to 74.0
|
58 percentage of participants
Interval 53.0 to 63.0
|
73 percentage of participants
Interval 68.0 to 77.0
|
66 percentage of participants
Interval 61.0 to 70.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for detailsPopulation: Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Number of Participants With Treatment Modification
|
152 participants
|
239 participants
|
138 participants
|
216 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At week 48 and 96Population: Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Cumulative Probability of Not Experiencing Treatment Modification
Week 48
|
80 percentage of participants
Interval 76.0 to 84.0
|
67 percentage of participants
Interval 63.0 to 71.0
|
86 percentage of participants
Interval 82.0 to 89.0
|
73 percentage of participants
Interval 69.0 to 77.0
|
|
Cumulative Probability of Not Experiencing Treatment Modification
Week 96
|
73 percentage of participants
Interval 69.0 to 77.0
|
56 percentage of participants
Interval 52.0 to 61.0
|
77 percentage of participants
Interval 73.0 to 81.0
|
62 percentage of participants
Interval 58.0 to 66.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for detailsPopulation: Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks and before 24 weeks or \>=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Number of Participants With Regimen Failure
|
162 participants
|
246 participants
|
157 participants
|
233 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At week 48 and 96Population: Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level \>= 1000 copies/mL at or after 16 weeks and before 24 weeks or \>=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Outcome measures
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 Participants
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 Participants
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 Participants
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 Participants
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Cumulative Probability of Not Experiencing Regimen Failure
Week 48
|
79 percentage of participants
Interval 75.0 to 82.0
|
64 percentage of participants
Interval 59.0 to 68.0
|
80 percentage of participants
Interval 76.0 to 84.0
|
66 percentage of participants
Interval 62.0 to 70.0
|
|
Cumulative Probability of Not Experiencing Regimen Failure
Week 96
|
70 percentage of participants
Interval 66.0 to 74.0
|
54 percentage of participants
Interval 49.0 to 58.0
|
73 percentage of participants
Interval 69.0 to 77.0
|
57 percentage of participants
Interval 52.0 to 61.0
|
Adverse Events
EFV, FTC/TDF, and Placebo ABC/3TC
Serious events: 48 serious events
Other events: 434 other events
Deaths: 0 deaths
EFV, Placebo FTC/TDF, and ABC/3TC
Serious events: 62 serious events
Other events: 433 other events
Deaths: 0 deaths
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
Serious events: 58 serious events
Other events: 453 other events
Deaths: 0 deaths
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
Serious events: 71 serious events
Other events: 461 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 participants at risk
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 participants at risk
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 participants at risk
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 participants at risk
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Convulsion
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Cardiac disorders
Coronary artery disease
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Death
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.1%
5/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Accidental death
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Cardiac disorders
Acute myocardial infarction
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Adverse drug reaction
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Alanine aminotransferase increased
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Altered state of consciousness
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Blood and lymphatic system disorders
Anaemia
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.0%
14/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.1%
5/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood creatinine increased
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood triglycerides
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood triglycerides increased
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.87%
4/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Blood and lymphatic system disorders
Burkitt's lymphoma
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Cardio-respiratory arrest
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Cardiac disorders
Cardiovascular disorder
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Cellulitis
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Cerebrovascular accident
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Chest pain
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Hepatobiliary disorders
Cholecystitis
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Depression
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Dizziness
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Immune system disorders
Drug hypersensitivity
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.1%
5/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.5%
7/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
HIV infection
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Headache
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
2.8%
13/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.0%
14/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Pain
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Immune system disorders
Hypersensitivity
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory carcinoma of the breast
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Lipase increased
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Liver function test abnormal
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Lung infection pseudomonal
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Malaise
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Meningitis cryptococcal
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Mental status changes
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Cardiac disorders
Myocardial infarction
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Injury, poisoning and procedural complications
Narcotic intoxication
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Injury, poisoning and procedural complications
Overdose
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Personality change
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Infections and infestations
Pneumonia
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Pyrexia
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Suicidal ideation
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Suicide attempt
|
0.65%
3/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Transaminases increased
|
0.43%
2/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.00%
0/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.22%
1/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
Other adverse events
| Measure |
EFV, FTC/TDF, and Placebo ABC/3TC
n=461 participants at risk
Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
EFV, Placebo FTC/TDF, and ABC/3TC
n=461 participants at risk
Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC
n=464 participants at risk
Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
|
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC
n=462 participants at risk
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|---|---|---|---|---|
|
Psychiatric disorders
Abnormal dreams
|
4.3%
20/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.6%
26/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.43%
2/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
0.65%
3/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Alanine aminotransferase increased
|
14.5%
67/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
15.2%
70/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
11.4%
53/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
11.3%
52/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
73/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
14.5%
67/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
13.6%
63/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
13.2%
61/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood bilirubin increased
|
10.2%
47/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
12.4%
57/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
88.8%
412/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
93.1%
430/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood cholesterol
|
11.1%
51/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
15.2%
70/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
8.6%
40/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
12.8%
59/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood cholesterol abnormal
|
47.7%
220/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
61.2%
282/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
38.6%
179/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
57.8%
267/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood creatinine increased
|
4.6%
21/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.9%
27/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
9.1%
42/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.9%
32/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood glucose abnormal
|
39.9%
184/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
42.3%
195/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
38.8%
180/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
43.7%
202/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood phosphorus decreased
|
7.8%
36/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.9%
32/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.2%
29/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.3%
29/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood glucose decreased
|
7.4%
34/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.2%
24/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.6%
26/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.1%
28/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood sodium decreased
|
8.2%
38/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
9.8%
45/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
10.3%
48/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
7.6%
35/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Blood triglycerides
|
5.4%
25/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
10.6%
49/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.9%
18/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
10.0%
46/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
16/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.0%
23/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.2%
15/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.8%
27/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Depression
|
8.9%
41/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
8.7%
40/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
7.3%
34/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
9.1%
42/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Diarrhoea
|
11.7%
54/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
16.9%
78/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
13.1%
61/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
17.5%
81/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Dizziness
|
9.1%
42/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
11.5%
53/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.4%
16/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.9%
9/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Immune system disorders
Drug hypersensitivity
|
4.8%
22/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
10.6%
49/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.2%
29/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.5%
30/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Fatigue
|
8.9%
41/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
10.6%
49/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.2%
24/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
7.6%
35/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Haemoglobin decreased
|
4.1%
19/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.9%
27/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.9%
18/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.2%
24/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Nervous system disorders
Headache
|
8.0%
37/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
8.9%
41/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.2%
29/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
9.1%
42/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Vascular disorders
Hypertension
|
6.3%
29/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.9%
27/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.0%
14/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.8%
27/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Psychiatric disorders
Insomnia
|
6.1%
28/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
7.2%
33/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.7%
8/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
4.3%
20/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Low density lipoprotein
|
8.7%
40/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
11.9%
55/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.8%
27/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
9.1%
42/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Low density lipoprotein abnormal
|
40.8%
188/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
49.5%
228/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
33.6%
156/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
44.4%
205/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Nausea
|
12.6%
58/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
16.7%
77/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
11.0%
51/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
18.6%
86/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Neutrophil count decreased
|
17.1%
79/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
19.1%
88/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
14.9%
69/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
15.4%
71/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
12/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.4%
25/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.9%
9/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.4%
25/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
Platelet count decreased
|
6.1%
28/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.9%
27/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.4%
25/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.4%
25/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
General disorders
Pyrexia
|
4.3%
20/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
11.3%
52/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
7.8%
36/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
10.8%
50/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
17/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.6%
26/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
3.9%
18/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.4%
25/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
2.2%
10/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
6.3%
29/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
1.9%
9/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
4.3%
20/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
24/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
9.3%
43/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
5.2%
24/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
8.2%
38/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
|
Investigations
White blood cell count decreased
|
9.3%
43/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
10.2%
47/461 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
8.0%
37/464 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
7.8%
36/462 • From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea \& other Grade\>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events \& diseases. All Creatinine, bilirubin, fasting lipid \& glucose, and other Grade\>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
|
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
Restriction type: LTE60