Trial Outcomes & Findings for Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV (NCT NCT00244712)
NCT ID: NCT00244712
Last Updated: 2010-06-08
Results Overview
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA \<50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 copies/mL and \>=100,000 copies/mL).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
688 participants
Primary outcome timeframe
Week 48
Results posted on
2010-06-08
Participant Flow
Participants were recruited at 76 study sites in the US and 2 study sites in Puerto Rico between 26 July 2005 and 16 June 2006.
After screening, participants who had never received treatment for HIV-1 infection and had a viral load greater than or equal to 1,000 copies per milliliter of blood and any amount of CD4+ T-cells were equally randomized to 1 of 2 treatment groups.
Participant milestones
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Overall Study
STARTED
|
343
|
345
|
|
Overall Study
COMPLETED
|
234
|
221
|
|
Overall Study
NOT COMPLETED
|
109
|
124
|
Reasons for withdrawal
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
20
|
21
|
|
Overall Study
Protocol-Defined Virologic Failure
|
8
|
6
|
|
Overall Study
Lack of Compliance
|
10
|
11
|
|
Overall Study
Lost to Follow-up
|
45
|
52
|
|
Overall Study
Withdrawal by Subject
|
13
|
23
|
|
Overall Study
Protocol Violation, disease progression
|
13
|
11
|
Baseline Characteristics
Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV
Baseline characteristics by cohort
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=343 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=345 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
Total
n=688 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Baseline HIV-1 RNA Level
<100,000 copies/mL
|
188 participants
n=5 Participants
|
205 participants
n=7 Participants
|
393 participants
n=5 Participants
|
|
Baseline HIV-1 RNA Level
100,000 - <250,000 copies/mL
|
68 participants
n=5 Participants
|
75 participants
n=7 Participants
|
143 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
177 participants
n=5 Participants
|
174 participants
n=7 Participants
|
351 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
36 participants
n=5 Participants
|
36 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
73 participants
n=5 Participants
|
62 participants
n=7 Participants
|
135 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
270 participants
n=5 Participants
|
282 participants
n=7 Participants
|
552 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing Information
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Baseline CD4+ Cell Count Level
<50 cells per cmm
|
61 participants
n=5 Participants
|
70 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Baseline CD4+ Cell Count Level
50 - <200 cells per cmm
|
99 participants
n=5 Participants
|
110 participants
n=7 Participants
|
209 participants
n=5 Participants
|
|
Baseline CD4+ Cell Count Level
>= 200 cells per cmm
|
183 participants
n=5 Participants
|
165 participants
n=7 Participants
|
348 participants
n=5 Participants
|
|
Age Continuous
|
38.0 years
STANDARD_DEVIATION 9.80 • n=5 Participants
|
38.7 years
STANDARD_DEVIATION 9.55 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
287 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
563 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
122 participants
n=5 Participants
|
124 participants
n=7 Participants
|
246 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Baseline HIV-1 RNA Level
250,000 - <500,000 copies/mL
|
37 participants
n=5 Participants
|
33 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Baseline HIV-1 RNA Level
>=500,000 copies/mL
|
50 participants
n=5 Participants
|
32 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Centers for Disease Control (CDC) Classification
A: Asymptomatic HIV infection
|
229 participants
n=5 Participants
|
240 participants
n=7 Participants
|
469 participants
n=5 Participants
|
|
Centers for Disease Control (CDC) Classification
B: Symptomatic HIV infection
|
59 participants
n=5 Participants
|
48 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Centers for Disease Control (CDC) Classification
C: AIDS
|
55 participants
n=5 Participants
|
57 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Hepatitis B Infection
Reactive
|
19 participants
n=5 Participants
|
9 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Hepatitis B Infection
Non-Reactive
|
324 participants
n=5 Participants
|
334 participants
n=7 Participants
|
658 participants
n=5 Participants
|
|
Hepatitis B Infection
Missing
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Hepatitis C Infection
Reactive
|
27 participants
n=5 Participants
|
24 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Hepatitis C Infection
Non-Reactive
|
316 participants
n=5 Participants
|
319 participants
n=7 Participants
|
635 participants
n=5 Participants
|
|
Hepatitis C Infection
Missing
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Baseline CD4+ Cell Count
|
214 cells per cmm
n=5 Participants
|
193 cells per cmm
n=7 Participants
|
202 cells per cmm
n=5 Participants
|
|
Baseline HIV-1 RNA
|
4.903 log10 copies/mL
n=5 Participants
|
4.844 log10 copies/mL
n=7 Participants
|
4.876 log10 copies/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA \>=50 copies/mL.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA \<50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 copies/mL and \>=100,000 copies/mL).
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=343 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=345 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
|
67.5 percentage of participants
|
67.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48Population: The Intent-To-Treat-Exposed (ITT-E) population which included all patients that had received at least one dose of study medication. The secondary analysis methods were time to loss of virologic response (TLOVR), Observed (Obs), and missing/discontinuation=failure (M/D=F) analyses.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL).
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=343 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=345 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
TLOVR
|
62.6 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Obs
|
84.3 percentage of participants
|
86.8 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
M/D=F
|
64.3 percentage of participants
|
62.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 96Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL).
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=343 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=345 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
M=F, Switch Included
|
59.9 percentage of participants
|
58.0 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
TLOVR
|
52.1 percentage of participants
|
51.0 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Obs
|
86.9 percentage of participants
|
91.3 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
M/D=F
|
56.4 percentage of participants
|
54.5 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \<100,000 copies/mL.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=188 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=205 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
M=F, Switch Included, Week 48
|
71 percentage of participants
|
69 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
TLOVR, Week 48
|
67 percentage of participants
|
62 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Obs, Week 48
|
89 percentage of participants
|
88 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
MD=F, Week 48
|
68 percentage of participants
|
62 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
M=F, Switch Included, Week 96
|
63 percentage of participants
|
58 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
TLOVR, Week 96
|
57 percentage of participants
|
52 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Obs, Week 96
|
89 percentage of participants
|
94 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
MD=F, Week 96
|
59 percentage of participants
|
54 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were M=F, switch included, TLOVR, Observed, and M/D=F
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA \<50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \>=100,000 copies/mL.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=155 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=140 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
M=F, Switch Included, Week 48
|
63 percentage of participants
|
65 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
TLOVR, Week 48
|
57 percentage of participants
|
60 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Obs, Week 48
|
78 percentage of participants
|
86 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
M/D=F, Week 48
|
59 percentage of participants
|
62 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
M=F, Switch Included, Week 96
|
56 percentage of participants
|
58 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
TLOVR, Week 96
|
46 percentage of participants
|
51 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Obs, Week 96
|
84 percentage of participants
|
88 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
M/D=F, Week 96
|
54 percentage of participants
|
55 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (\<100,000 copies/mL and \>=100,000 copies/mL).
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=343 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=345 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
M=F, Switch Included, Week 48
|
75.2 percentage of participants
|
71.3 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
TLOVR, Week 48
|
70.9 percentage of participants
|
66.4 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
Obs, Week 48
|
93.8 percentage of participants
|
92.2 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
M/D=F, Week 48
|
71.4 percentage of participants
|
66.2 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
M=F, Switch Included, Week 96
|
63.9 percentage of participants
|
61.2 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
TLOVR, Week 96
|
58.4 percentage of participants
|
56.3 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
Obs, Week 96
|
92.8 percentage of participants
|
96.3 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
M/D=F, Week 96
|
60.1 percentage of participants
|
56.9 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \<100,000 copies/mL.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=188 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=205 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
M=F, Switch Included, Week 48
|
76 percentage of participants
|
71 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
TLOVR, Week 48
|
72 percentage of participants
|
66 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Obs, Week 48
|
94 percentage of participants
|
91 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
M/D=F, Week 48
|
72 percentage of participants
|
65 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
M=F, Switch Included, Week 96
|
65 percentage of participants
|
60 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
TLOVR, Week 96
|
60 percentage of participants
|
55 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Obs, Week 96
|
92 percentage of participants
|
97 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
M/D=F, Week 96
|
61 percentage of participants
|
56 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: The Intent-To-Treat-Exposed (ITT-E) population. The secondary analysis methods were missing=failure (M=F), switch included, TLOVR, Observed, and M/D=F
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA \<400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA \>=100,000 copies/mL.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=155 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=140 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
M=F, Switch Included, Week 48
|
75 percentage of participants
|
71 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
TLOVR, Week 48
|
70 percentage of participants
|
67 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Obs, Week 48
|
94 percentage of participants
|
94 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
M/D=F, Week 48
|
71 percentage of participants
|
68 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
M=F, Switch Included, Week 96
|
63 percentage of participants
|
63 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
TLOVR, Week 96
|
56 percentage of participants
|
58 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Obs, Week 96
|
93 percentage of participants
|
96 percentage of participants
|
|
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
M/D=F, Week 96
|
59 percentage of participants
|
58 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=236 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=219 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Median Change From Baseline in HIV-1 RNA at Week 48 and 96
Week 48
|
-3.142 log10 copies/mL
Interval -4.847 to 0.97
|
-3.131 log10 copies/mL
Interval -4.874 to 2.53
|
|
Median Change From Baseline in HIV-1 RNA at Week 48 and 96
Week 96
|
-3.114 log10 copies/mL
Interval -5.304 to 0.819
|
-3.165 log10 copies/mL
Interval -4.874 to 0.139
|
SECONDARY outcome
Timeframe: Weeks 48 and 96Population: The Intent-To-Treat-Exposed (ITT-E) population, observed analysis.
A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=234 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=218 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
Week 48
|
201.0 cells per cmm
Interval -170.0 to 903.0
|
173.0 cells per cmm
Interval -190.0 to 921.0
|
|
Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
Week 96
|
250.0 cells per cmm
Interval -226.0 to 1033.0
|
246.5 cells per cmm
Interval -116.0 to 793.0
|
SECONDARY outcome
Timeframe: Baseline to Week 96Population: The Intent-To-Treat-Exposed (ITT-E) population
The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA \<200 copies/mL or HIV-1 RNA rebound \>= 200 copies/mL on two consecutive occasions.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=343 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=345 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
Protocol-defined virologic failure
|
49 participants
|
48 participants
|
|
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
Fail to confirm HIV-1 RNA <200 copies/mL by wk 24
|
21 participants
|
24 participants
|
|
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
Confirmed HIV-1 RNA rebound to >= 200 copies/mL
|
28 participants
|
24 participants
|
|
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
Suspected HIV-1 RNA rebound to >= 200 copies/mL
|
12 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline and time of virologic failure (up to Week 96)Population: Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=45 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=41 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
No. with paired genotypes at baseline and wk 96
|
45 participants
|
41 participants
|
|
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
Participants with treatment-emergent mutations
|
18 participants
|
22 participants
|
|
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
NRTI-associated mutations
|
11 participants
|
17 participants
|
|
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
NNRTI-associated mutations
|
4 participants
|
3 participants
|
|
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
PI-associated mutations
|
11 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline and time of virologic failure (up to Week 96)Population: Participants in the Intent-To-Treat-Exposed (ITT-E) population who met the confirmed virologic failure criteria and had the M184 mutations.
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=11 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=17 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V)
|
11 participants
|
17 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno susceptibility to lamivudine/M184V
|
4 participants
|
9 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced phen susceptibility to lamivudine/M184M/V
|
3 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno susceptibility to lamivudine/M184M/I
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno susceptibility to lamivudine/M184A/V
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno susceptibility to lamivudine/M184I
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno suscept. to lamivudine/M184M/I/V
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno suscept. to emtricitabine/M184V
|
4 participants
|
9 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno suscept. to emtricitabine/M184M/V
|
3 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno suscept. to emtricitabine/M184M/I
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno suscept. to emtricitabine/M184A/V
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno suscept. to emtricitabine/M184I
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Reduced pheno suscept. to emtricitabine/M184M/I/V
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through 96 weeksPopulation: The Safety population which included all randomized participants who received at least one dose of study medication.
The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.
Outcome measures
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
n=343 Participants
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
n=345 Participants
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Severe or Grade 3
|
4 participants
|
1 participants
|
|
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Participants (Par.) with suspected ABC HSR
|
14 participants
|
3 participants
|
|
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Mild or Grade 1
|
1 participants
|
0 participants
|
|
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Moderate or Grade 2
|
8 participants
|
2 participants
|
|
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Not Applicable
|
1 participants
|
0 participants
|
|
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Par. with proximal renal tubule dysfunction
|
0 participants
|
5 participants
|
Adverse Events
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
Serious events: 42 serious events
Other events: 182 other events
Deaths: 0 deaths
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
Serious events: 45 serious events
Other events: 182 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.87%
3/343
|
1.2%
4/345
|
|
Infections and infestations
Gastroenteritis
|
0.29%
1/343
|
0.29%
1/345
|
|
Infections and infestations
Meningitis cryptococcal
|
0.29%
1/343
|
0.29%
1/345
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/343
|
0.58%
2/345
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.29%
1/343
|
0.29%
1/345
|
|
Infections and infestations
Staphylococcal infection
|
0.29%
1/343
|
0.29%
1/345
|
|
Infections and infestations
Abscess
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Abscess limb
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Bronchitis
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Cellulitis
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Cryptococcal fungaemia
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Gastroenteritis viral
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Kidney infection
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Meningitis viral
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Perianal abscess
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Sepsis
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/343
|
0.29%
1/345
|
|
Infections and infestations
Tonsilitis streptococcal
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Tuberculosis
|
0.29%
1/343
|
0.00%
0/345
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/343
|
0.29%
1/345
|
|
Immune system disorders
Drug hypersensitivity
|
3.5%
12/343
|
0.87%
3/345
|
|
Immune system disorders
Hypersensitivity
|
0.58%
2/343
|
0.00%
0/345
|
|
Immune system disorders
Immune reconstitution syndrome
|
0.58%
2/343
|
0.00%
0/345
|
|
Gastrointestinal disorders
Haematemesis
|
0.29%
1/343
|
0.29%
1/345
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/343
|
0.58%
2/345
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/343
|
0.29%
1/345
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/343
|
0.29%
1/345
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/343
|
0.29%
1/345
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.29%
1/343
|
0.00%
0/345
|
|
Gastrointestinal disorders
Proctitis
|
0.29%
1/343
|
0.00%
0/345
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/343
|
0.29%
1/345
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.58%
2/343
|
0.00%
0/345
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumor
|
0.00%
0/343
|
0.29%
1/345
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/343
|
0.29%
1/345
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.29%
1/343
|
0.00%
0/345
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/343
|
0.29%
1/345
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.29%
1/343
|
0.00%
0/345
|
|
Nervous system disorders
Transient ischaemic attack
|
0.29%
1/343
|
0.29%
1/345
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/343
|
0.29%
1/345
|
|
Nervous system disorders
Brain mass
|
0.29%
1/343
|
0.00%
0/345
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/343
|
0.29%
1/345
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/343
|
0.29%
1/345
|
|
Nervous system disorders
Migraine
|
0.00%
0/343
|
0.29%
1/345
|
|
Nervous system disorders
Syncope
|
0.00%
0/343
|
0.29%
1/345
|
|
General disorders
Chest pain
|
0.58%
2/343
|
0.00%
0/345
|
|
General disorders
Pyrexia
|
0.29%
1/343
|
0.29%
1/345
|
|
General disorders
Death
|
0.00%
0/343
|
0.29%
1/345
|
|
General disorders
Gait disturbance
|
0.29%
1/343
|
0.00%
0/345
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/343
|
0.29%
1/345
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.29%
1/343
|
0.58%
2/345
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.29%
1/343
|
0.00%
0/345
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/343
|
0.00%
0/345
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/343
|
0.29%
1/345
|
|
Psychiatric disorders
Dependence
|
0.00%
0/343
|
0.29%
1/345
|
|
Psychiatric disorders
Depression
|
0.29%
1/343
|
0.00%
0/345
|
|
Psychiatric disorders
Major depression
|
0.00%
0/343
|
0.29%
1/345
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/343
|
0.29%
1/345
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/343
|
0.29%
1/345
|
|
Blood and lymphatic system disorders
Anaemia
|
0.58%
2/343
|
0.58%
2/345
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.29%
1/343
|
0.29%
1/345
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/343
|
0.29%
1/345
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/343
|
0.29%
1/345
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.29%
1/343
|
0.00%
0/345
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/343
|
0.29%
1/345
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/343
|
0.29%
1/345
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/343
|
0.29%
1/345
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.29%
1/343
|
0.00%
0/345
|
|
Hepatobiliary disorders
Hepatitic cirrhosis
|
0.00%
0/343
|
0.29%
1/345
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/343
|
0.29%
1/345
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.29%
1/343
|
0.00%
0/345
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/343
|
0.29%
1/345
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/343
|
0.29%
1/345
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/343
|
0.29%
1/345
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/343
|
0.58%
2/345
|
|
Vascular disorders
Hypertension
|
0.00%
0/343
|
0.29%
1/345
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/343
|
0.29%
1/345
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
1/343
|
0.00%
0/345
|
|
Injury, poisoning and procedural complications
Head injury
|
0.29%
1/343
|
0.00%
0/345
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/343
|
0.29%
1/345
|
|
Endocrine disorders
Adrenal insufficiency
|
0.29%
1/343
|
0.00%
0/345
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/343
|
0.29%
1/345
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/343
|
0.29%
1/345
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/343
|
0.00%
0/345
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/343
|
0.29%
1/345
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/343
|
0.29%
1/345
|
|
Surgical and medical procedures
Debridement
|
0.29%
1/343
|
0.00%
0/345
|
Other adverse events
| Measure |
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)
1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
|
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV
1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
24.8%
85/343
|
23.2%
80/345
|
|
Gastrointestinal disorders
Nausea
|
9.6%
33/343
|
8.1%
28/345
|
|
Investigations
Blood triglycerides increased
|
9.0%
31/343
|
7.5%
26/345
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
25/343
|
9.0%
31/345
|
|
Investigations
Glomerular filtration rate decreased
|
6.1%
21/343
|
8.1%
28/345
|
|
Psychiatric disorders
Depression
|
7.3%
25/343
|
6.7%
23/345
|
|
Nervous system disorders
Headache
|
7.3%
25/343
|
6.7%
23/345
|
|
Investigations
Blood cholesterol increased
|
7.9%
27/343
|
5.8%
20/345
|
|
Infections and infestations
Sinusitis
|
5.5%
19/343
|
7.0%
24/345
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
21/343
|
4.3%
15/345
|
|
General disorders
Fatigue
|
6.1%
21/343
|
3.8%
13/345
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER