Trial Outcomes & Findings for Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects (NCT NCT00197145)
NCT ID: NCT00197145
Last Updated: 2018-11-02
Results Overview
Assessment for plasma HIV-1 RNA was done at Week 24 and also planned at Week 48 by polymerase chain reaction (PCR) analysis. Data is reported for number of participants with plasma HIV-1 RNA \<400 copies/mL at Week 24. Data was not collected for Week 48 due to early termination of the study.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
24 participants
Primary outcome timeframe
Week 24
Results posted on
2018-11-02
Participant Flow
The study was planned on 406 male or female participants infected with Human immunodeficiency type 1 (HIV-1) virus, aged 18 years or older, across 15 centres in the United States and at 1 site in Canada from 21 July 2005 to 11 September 2007. Study was early terminated prior to the completion of enrollment.
A total of 24 participants comprised All Randomized Subject Population who were randomized in a ratio of 1:1 to GW873140 (aplaviroc \[APL\])+optimized background therapy (OBT) and placebo+OBT. Intent-to Treat (ITT) Population was n=24, used for all analysis.
Participant milestones
| Measure |
APL + OBT
Participants were administered APL tablets orally as 400 milligram (mg) twice daily (BID) for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was ritonavir (RTV)- boosted protease inhibitor (PI). Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. Fixed dose combination tablets (FDC) was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (lopinavir \[LPV\]/RTV) was counted as one drug.
|
Placebo + OBT
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was ritonavir (RTV)- boosted protease inhibitor (PI). Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. Fixed dose combination tablets (FDC) was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (lopinavir \[LPV\]/RTV) was counted as one drug.
|
|---|---|---|
|
Period 1: Randomized Treatment Phase
STARTED
|
13
|
11
|
|
Period 1: Randomized Treatment Phase
COMPLETED
|
0
|
0
|
|
Period 1: Randomized Treatment Phase
NOT COMPLETED
|
13
|
11
|
|
Period 2 : Open Label Phase
STARTED
|
10
|
0
|
|
Period 2 : Open Label Phase
COMPLETED
|
0
|
0
|
|
Period 2 : Open Label Phase
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
| Measure |
APL + OBT
Participants were administered APL tablets orally as 400 milligram (mg) twice daily (BID) for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was ritonavir (RTV)- boosted protease inhibitor (PI). Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. Fixed dose combination tablets (FDC) was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (lopinavir \[LPV\]/RTV) was counted as one drug.
|
Placebo + OBT
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was ritonavir (RTV)- boosted protease inhibitor (PI). Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. Fixed dose combination tablets (FDC) was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (lopinavir \[LPV\]/RTV) was counted as one drug.
|
|---|---|---|
|
Period 1: Randomized Treatment Phase
Withdrawal by Subject
|
1
|
1
|
|
Period 1: Randomized Treatment Phase
Sponsor terminated study
|
10
|
8
|
|
Period 1: Randomized Treatment Phase
Other
|
2
|
2
|
|
Period 2 : Open Label Phase
Insufficient viral load response
|
1
|
0
|
|
Period 2 : Open Label Phase
Protocol defined virological failure
|
3
|
0
|
|
Period 2 : Open Label Phase
Availability of alternative ART
|
2
|
0
|
|
Period 2 : Open Label Phase
Were ongoing till data freeze
|
3
|
0
|
|
Period 2 : Open Label Phase
Other
|
1
|
0
|
Baseline Characteristics
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects
Baseline characteristics by cohort
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 Years
STANDARD_DEVIATION 7.03 • n=5 Participants
|
44.5 Years
STANDARD_DEVIATION 5.68 • n=7 Participants
|
45.8 Years
STANDARD_DEVIATION 6.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intent to Treat (ITT) Population comprised of all participants randomized with evidence of receiving at least one dose of study medication. The analysis was an observed analysis and only participants with data available at the indicated timepoints were included.
Assessment for plasma HIV-1 RNA was done at Week 24 and also planned at Week 48 by polymerase chain reaction (PCR) analysis. Data is reported for number of participants with plasma HIV-1 RNA \<400 copies/mL at Week 24. Data was not collected for Week 48 due to early termination of the study.
Outcome measures
| Measure |
APL + OBT
n=7 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Week 40Population: ITT Population. Only those participants available at the specified time points were analyzed.
The area under the plasma HIV-1 RNA curve (AUC) was computed using the trapezoidal rule for all assessments (scheduled and unscheduled) at their actual time points. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values. Participants without a Baseline assessment was removed from the analysis. The AAUCMB was computed by the AUC divided by the duration of the profile (i.e., the number of days on randomized therapy) minus the Baseline measurement. Data is reported up to Week 40 only due to early termination of the study.
Outcome measures
| Measure |
APL + OBT
n=11 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=7 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Average Area Under the Curve Minus Baseline (AAUCMB) of Plasma HIV-1 RNA Through the Entire Study Period
|
-2.03 Log10 copies/mL
Standard Deviation 0.990
|
-1.14 Log10 copies/mL
Standard Deviation 0.766
|
PRIMARY outcome
Timeframe: Day 1 up to Week 12 Follow-up of the Randomized Treatment phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phasePopulation: ITT Population. Data were not collected for this outcome measure due to early termination of the study.
The plasma HIV-1 RNA polymerase chain reaction (PCR) assessments were planned at pre-Baseline (between 1 and 14 days prior to Day 1), up to Week 12 Follow- up of the Randomized Phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phase, however the study was early terminated at Week 40. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Population: ITT Population. The analysis was an observed analysis and only participants with data available at the indicated timepoints were included.
Assessment for plasma HIV-1 RNA was done at Week 24 and also planned at Week 48 by PCR analysis. Data is reported for number of participants with plasma HIV-1 RNA \<50 copies/mL at Week 24. Data was not collected for Week 48 due to early termination of the study.
Outcome measures
| Measure |
APL + OBT
n=7 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Follow-up (Week 52)Population: ITT Population.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, hypersensitivity reaction to abacavir. AEs were classified as potentially drug-related, based on the investigator's judgment.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation
Any AE
|
11 Participants
|
5 Participants
|
|
Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation
Any SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation
Any Death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation
Drug-related AE
|
7 Participants
|
2 Participants
|
|
Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation
Any AE Leading to Treatment Discontinuation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 40Population: ITT Population.
The participants with treatment emergent toxicities of laboratory abnormalities for chemistry data is reported . Participants with toxicities were categorized according to the division of AIDS (DAIDS) toxicity grading scale. Scale ranges from grade 1(mild)=symptoms causing no or minimal interference with usual social \& functional activities, grade 2 (moderate)=symptoms causing greater than minimal interference with usual social \& functional activities, grade 3 (severe)=symptoms causing inability to perform usual social \& functional activities and grade 4 (potentially life threatening)=symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Scale ranges from 1-4, where higher grade reflects greater severity of symptoms. Baseline was defined as assessments done at Day 1. Only those parameters for which at least one value of toxicity grade was reported are summarized.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Alanine Amino Transferase (ALT), Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
ALT, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Albumin, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Alkaline Phosphatase (ALP), Grade 1
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
CK, Grade 3
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Lipase, Grade 1
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Sodium, Grade 1
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Total Bilirubin, Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Triglycerides, Grade 2
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Glucose, Grade 1
|
3 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Glucose, Grade 2
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Glucose, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Low Density lipoprotein (LDL) Cholesterol, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Lipase, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Potassium, Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Total Bilirubin, Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Total Bilirubin, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Triglycerides, Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Aspartate Amino Transferase (AST), Grade 1
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
AST, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Carbon Dioxide content/Bicarbonate (CO2), Grade 1
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Cholesterol, Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Cholesterol, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Creatine Kinase (CK), Grade 1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
CK, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline
Creatinine, Grade 1
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase
ALT, Week 12
|
-7.231 International unit per liter (IU/L)
Standard Deviation 28.5048
|
9.250 International unit per liter (IU/L)
Standard Deviation 18.8569
|
|
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase
ALT, Week 24
|
-5.429 International unit per liter (IU/L)
Standard Deviation 19.4324
|
—
|
|
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase
ALP, Week 12
|
-7.154 International unit per liter (IU/L)
Standard Deviation 24.1069
|
25.750 International unit per liter (IU/L)
Standard Deviation 18.9275
|
|
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase
ALP, Week 24
|
-3.571 International unit per liter (IU/L)
Standard Deviation 19.4753
|
—
|
|
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase
AST, Week 12
|
-4.231 International unit per liter (IU/L)
Standard Deviation 15.9330
|
4.750 International unit per liter (IU/L)
Standard Deviation 8.4212
|
|
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase
AST, Week 24
|
-3.857 International unit per liter (IU/L)
Standard Deviation 13.5699
|
—
|
|
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase
CK, Week 12
|
-3.462 International unit per liter (IU/L)
Standard Deviation 185.5095
|
37.250 International unit per liter (IU/L)
Standard Deviation 78.9910
|
|
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase
CK, Week 24
|
102.714 International unit per liter (IU/L)
Standard Deviation 553.4250
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Cholesterol, Week 24
|
-0.539 Millimole (MMOL)/L
Standard Deviation 0.8367
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
LDL, Week 12
|
-0.552 Millimole (MMOL)/L
Standard Deviation 0.5635
|
-0.500 Millimole (MMOL)/L
Standard Deviation NA
SD was not generated as only 1 participant was assessed during this time point.
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Triglycerides, Week 12
|
1.194 Millimole (MMOL)/L
Standard Deviation 1.3095
|
-0.240 Millimole (MMOL)/L
Standard Deviation NA
SD was not generated as only 1 participant was assessed during this time point.
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
CO2 content/bicarbonate, Week 12
|
0.154 Millimole (MMOL)/L
Standard Deviation 2.5445
|
-1.250 Millimole (MMOL)/L
Standard Deviation 4.1932
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
CO2 content/bicarbonate, Week 24
|
2.429 Millimole (MMOL)/L
Standard Deviation 3.6450
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Chloride, Week 12
|
0.462 Millimole (MMOL)/L
Standard Deviation 3.4306
|
-2.500 Millimole (MMOL)/L
Standard Deviation 2.6458
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Chloride, Week 24
|
0.857 Millimole (MMOL)/L
Standard Deviation 2.7946
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Cholesterol, Week 12
|
-0.200 Millimole (MMOL)/L
Standard Deviation 0.7095
|
-0.700 Millimole (MMOL)/L
Standard Deviation NA
SD was not generated as only 1 participant was assessed during this time point.
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Glucose, Week 12
|
0.415 Millimole (MMOL)/L
Standard Deviation 3.2246
|
1.150 Millimole (MMOL)/L
Standard Deviation 1.3964
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Glucose, Week 24
|
-0.357 Millimole (MMOL)/L
Standard Deviation 1.8063
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
HDL, Week 12
|
-0.036 Millimole (MMOL)/L
Standard Deviation 0.2340
|
-0.100 Millimole (MMOL)/L
Standard Deviation NA
SD was not generated as only 1 participant was assessed during this time point.
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
HDL, Week 24
|
0.026 Millimole (MMOL)/L
Standard Deviation 0.2028
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
LDL, Week 24
|
-0.597 Millimole (MMOL)/L
Standard Deviation 0.6607
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Potassium, Week 12
|
0.038 Millimole (MMOL)/L
Standard Deviation 0.3906
|
-0.225 Millimole (MMOL)/L
Standard Deviation 0.3304
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Potassium, Week 24
|
-0.114 Millimole (MMOL)/L
Standard Deviation 0.1952
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Sodium, Week 12
|
-0.846 Millimole (MMOL)/L
Standard Deviation 1.5730
|
-2.500 Millimole (MMOL)/L
Standard Deviation 3.6968
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Sodium, Week 24
|
0.714 Millimole (MMOL)/L
Standard Deviation 1.9760
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Triglycerides, Week 24
|
0.071 Millimole (MMOL)/L
Standard Deviation 0.7076
|
—
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Urea, Week 12
|
-0.162 Millimole (MMOL)/L
Standard Deviation 2.3835
|
0.375 Millimole (MMOL)/L
Standard Deviation 2.9545
|
|
Change From Baseline in Chemistry Parameters of CO2 Content/Bicarbonate, Chloride, Cholesterol, Glucose, High DL Cholesterol, LDL Cholesterol, Triglycerides, Potassium, Urea and Sodium During the Randomized Treatment Phase
Urea, Week 24
|
-0.343 Millimole (MMOL)/L
Standard Deviation 2.3572
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase
Creatinine, Week 12
|
-1.385 Micromole (UMOL)/L
Standard Deviation 11.3397
|
13.000 Micromole (UMOL)/L
Standard Deviation 11.1056
|
|
Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase
Creatinine, Week 24
|
-2.714 Micromole (UMOL)/L
Standard Deviation 12.7504
|
—
|
|
Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase
Total Bilirubin, Week 12
|
0.769 Micromole (UMOL)/L
Standard Deviation 18.8244
|
-0.500 Micromole (UMOL)/L
Standard Deviation 6.8069
|
|
Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase
Total Bilirubin, Week 24
|
8.286 Micromole (UMOL)/L
Standard Deviation 31.0790
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase
Week 12
|
1.385 Gram (g)/L
Standard Deviation 2.6627
|
3.750 Gram (g)/L
Standard Deviation 2.5000
|
|
Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase
Week 24
|
2.000 Gram (g)/L
Standard Deviation 3.5590
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase
Week 12
|
6.636 U/L
Standard Deviation 8.4531
|
0.000 U/L
Standard Deviation 4.2426
|
|
Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase
Week 24
|
12.571 U/L
Standard Deviation 20.3867
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Platelet Count, Week 12
|
47.846 Giga cells (GI)/L
Standard Deviation 38.5202
|
-3.500 Giga cells (GI)/L
Standard Deviation 33.2340
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Basophils, Week 12
|
-0.003 Giga cells (GI)/L
Standard Deviation 0.0085
|
-0.005 Giga cells (GI)/L
Standard Deviation 0.0212
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Basophils, Week 24
|
-0.000 Giga cells (GI)/L
Standard Deviation 0.0153
|
—
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Eosinophils, Week 12
|
-0.027 Giga cells (GI)/L
Standard Deviation 0.1013
|
0.090 Giga cells (GI)/L
Standard Deviation 0.1697
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Eosinophils, Week 24
|
-0.010 Giga cells (GI)/L
Standard Deviation 0.0876
|
—
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Lymphocytes, Week 12
|
0.573 Giga cells (GI)/L
Standard Deviation 0.4762
|
0.050 Giga cells (GI)/L
Standard Deviation 0.2970
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Lymphocytes, Week 24
|
0.373 Giga cells (GI)/L
Standard Deviation 0.7915
|
—
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Monocytes, Week 12
|
0.041 Giga cells (GI)/L
Standard Deviation 0.1398
|
-0.095 Giga cells (GI)/L
Standard Deviation 0.2758
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Monocytes, Week 24
|
0.079 Giga cells (GI)/L
Standard Deviation 0.0756
|
—
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Platelet Count, Week 24
|
70.143 Giga cells (GI)/L
Standard Deviation 51.2199
|
—
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Total Neutrophils, Week 12
|
0.963 Giga cells (GI)/L
Standard Deviation 1.0130
|
-0.935 Giga cells (GI)/L
Standard Deviation 0.3889
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
Total Neutrophils, Week 24
|
0.861 Giga cells (GI)/L
Standard Deviation 0.9786
|
—
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
WBC Count, Week 12
|
1.546 Giga cells (GI)/L
Standard Deviation 1.1125
|
-0.900 Giga cells (GI)/L
Standard Deviation 1.1314
|
|
Change From Baseline in Haematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Count During the Randomized Treatment Phase
WBC Count, Week 24
|
1.300 Giga cells (GI)/L
Standard Deviation 1.1015
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Haematology Parameter of Mean Corpuscle Volume (MCV) During the Randomized Treatment Phase
Week 12
|
-3.000 Femtoliter (FL)
Standard Deviation 7.7567
|
-1.500 Femtoliter (FL)
Standard Deviation 4.9497
|
|
Change From Baseline in Haematology Parameter of Mean Corpuscle Volume (MCV) During the Randomized Treatment Phase
Week 24
|
-3.429 Femtoliter (FL)
Standard Deviation 9.5019
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Haematology Parameter of Hematocrit During the Randomized Treatment Phase.
Week 12
|
0.010 Percentage of red blood cells
Standard Deviation 0.0354
|
0.026 Percentage of red blood cells
Standard Deviation 0.0099
|
|
Change From Baseline in Haematology Parameter of Hematocrit During the Randomized Treatment Phase.
Week 24
|
-0.022 Percentage of red blood cells
Standard Deviation 0.0344
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
Assessment was performed at Day 1, Week 12 and Week 24. Baseline was defined as the assessments done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase
Week 12
|
4.923 g/L
Standard Deviation 9.9621
|
6.500 g/L
Standard Deviation 4.9497
|
|
Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase
Week 24
|
-4.000 g/L
Standard Deviation 10.2144
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 4 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
12-lead ECG assessments were obtained at Day 1 (triplicate measurements), Week 4 and Week 24. The assessments were done using an ECG machine that automatically calculated the heart rate. Baseline was defined as the mean of the triplicate assessment done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 4 and 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Electrocardiograph (ECG) Parameter of Heart Rate (HR) During the Randomized Treatment Phase
Week 4
|
5.6 Beats per minute (Bpm)
Standard Deviation 12.74
|
4.3 Beats per minute (Bpm)
Standard Deviation 11.54
|
|
Change From Baseline in Electrocardiograph (ECG) Parameter of Heart Rate (HR) During the Randomized Treatment Phase
Week 24
|
-3.9 Beats per minute (Bpm)
Standard Deviation 8.11
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 4 and Week 24Population: ITT Population. Only those participants available at the specified time points were analyzed.
12-lead ECG assessments were obtained at Day 1 (triplicate measurements), Week 4 and Week 24. The assessments were done using an ECG machine that automatically measured RR, PR, QRS, uncorrected QT, QTc (Bazette) and QTc (Fridericia) intervals. Baseline was defined as the mean of the triplicate assessment done at Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 4 and Week 24) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
QTc Interval (Bazette), Week 4
|
-4.5 Millisecond (msec)
Standard Deviation 27.68
|
15.4 Millisecond (msec)
Standard Deviation 14.64
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
QRS Duration, Week 4
|
3.2 Millisecond (msec)
Standard Deviation 7.08
|
0.4 Millisecond (msec)
Standard Deviation 7.13
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
RR Interval, Week 4
|
-69.8 Millisecond (msec)
Standard Deviation 112.21
|
-52.1 Millisecond (msec)
Standard Deviation 128.19
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
RR Interval, Week 24
|
52.2 Millisecond (msec)
Standard Deviation 73.16
|
—
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
Uncorrected QT Interval, Week 4
|
-18.3 Millisecond (msec)
Standard Deviation 30.87
|
1.2 Millisecond (msec)
Standard Deviation 28.81
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
Uncorrected QT Interval, Week 24
|
2.5 Millisecond (msec)
Standard Deviation 12.49
|
—
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
QTc Interval (Fridericia), Week 4
|
-9.3 Millisecond (msec)
Standard Deviation 26.05
|
10.2 Millisecond (msec)
Standard Deviation 14.06
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
QTc Interval (Fridericia), Week 24
|
-5.2 Millisecond (msec)
Standard Deviation 13.00
|
—
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
QTc Interval (Bazette), Week 24
|
-8.8 Millisecond (msec)
Standard Deviation 17.47
|
—
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
PR Interval, Week 4
|
-8.2 Millisecond (msec)
Standard Deviation 16.24
|
0.2 Millisecond (msec)
Standard Deviation 15.98
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
PR Interval, Week 24
|
2.5 Millisecond (msec)
Standard Deviation 10.07
|
—
|
|
Change From Baseline in ECG Parameter of RR Interval, Uncorrected QT Interval, QTc Interval (Fridericia), QTc Interval (Bazette), PR Interval and QRS Duration During the Randomized Treatment Phase
QRS Duration, Week 24
|
-1.3 Millisecond (msec)
Standard Deviation 7.68
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 12, Week 24 and Week 40Population: ITT Population. Only those participants available at the specified time points were analyzed.
The CD4 cell count is an indication of the strength of the immune system. The assessment of CD4 cell count was done by flow cytometry. Baseline was defined as the mean of the Baseline (Day 1) and pre-treatment visit values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Week 12, 24 and 40) values.
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase
Week 12
|
55.909 Cells/Cubic millimeter (mm^3)
Standard Deviation 53.8878
|
80.500 Cells/Cubic millimeter (mm^3)
Standard Deviation 177.4838
|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase
Week 24
|
27.000 Cells/Cubic millimeter (mm^3)
Standard Deviation 104.1441
|
—
|
|
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase
Week 40
|
153.000 Cells/Cubic millimeter (mm^3)
Standard Deviation 57.6888
|
—
|
SECONDARY outcome
Timeframe: Up to Week 12 Follow-up of the Randomized phase, up to Week 12 Follow-up of the Open Labeled Non-Randomized phase and every 6 months Follow-up of off study drug/on study phasePopulation: ITT Population. Data were not collected for this outcome measure due to early termination of the study.
The time to CDC class C AIDS-defining event or death was planned to be assessed as per the CDC 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Follow-up (Week 52)Population: Virologic Failure Population was defined as the number of participants with protocol defined virologic failure criteria.
Assessment for the development of antiretroviral resistance was performed at each visit up to Follow-up. The genotypic analysis of viral resistance associated mutations was done using protease and reverse transcriptase enzymes. The number of participants with treatment emergent changes in reverse transcriptase and protease genotypic mutations were reported.
Outcome measures
| Measure |
APL + OBT
n=6 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=3 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Number of Participants With Development of Antiretroviral Resistance to GW873140 400 mg BID and Other Antiretroviral Drugs
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: ITT Population.
The IC50 is a measure of the effectiveness of a substance in inhibiting a specific biological or biochemical function. IC50 was collected for abacavir (ABC), atazanavir (ATV), delavirdine (DLV), didanosine (DDI), efavirenz (EFV), emtricitabine, enfuvirtide , fosamprenavir (AMP), GW873140 (APL), indinavir (IDV), indinavir rooted with ritonavir (IDV/r), lamivudine, lopinavir rooted with ritonavir (LPV/r), nelfinavir (NFV), nevirapine (NVP), ritonavir (RTV), saquinavir (SQV), stavudine, tenofovir (TFV), tipranavir rooted with ritonavir (TPV/r), zidovudine (ZDV). Data is categorized for number of participants with each IC50 concentration of the individual drugs at Baseline (Day 1).
Outcome measures
| Measure |
APL + OBT
n=13 Participants
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 Participants
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
EFV >= 2.5
|
11 Participants
|
9 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
Enfuvirtide < 2.5
|
2 Participants
|
7 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
APL < 2.5
|
12 Participants
|
9 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
Lamivudine >= 3.5
|
13 Participants
|
7 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
LPV/r >= 10
|
10 Participants
|
5 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
NVP >= 2.5
|
12 Participants
|
9 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
RTV < 2.5
|
1 Participants
|
3 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
SQV >= 1.7
|
12 Participants
|
8 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
ABC < 4.5
|
0 Participants
|
4 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
ABC >= 4.5
|
13 Participants
|
7 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
ATV < 2.3
|
1 Participants
|
3 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
ATV >= 2.3
|
12 Participants
|
8 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
ATV/r < 5.2
|
1 Participants
|
5 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
ATV/r >= 5.2
|
12 Participants
|
6 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
DLV < 2.5
|
3 Participants
|
4 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
DLV >= 2.5
|
10 Participants
|
7 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
DDI < 1.3
|
0 Participants
|
5 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
DDI >= 1.3
|
13 Participants
|
6 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
EFV < 2.5
|
2 Participants
|
2 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
Emtricitabine < 3.5
|
0 Participants
|
3 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
Emtricitabine >= 3.5
|
13 Participants
|
8 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
Enfuvirtide >= 2.5
|
9 Participants
|
2 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
AMP < 2
|
1 Participants
|
4 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
AMP >= 2
|
12 Participants
|
7 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
APL >= 2.5
|
0 Participants
|
0 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
IDV < 2.1
|
1 Participants
|
3 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
IDV >= 2.1
|
12 Participants
|
8 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
IDV/r < 10
|
2 Participants
|
7 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
IDV/r >= 10
|
11 Participants
|
4 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
Lamivudine < 3.5
|
0 Participants
|
4 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
LPV/r < 10
|
3 Participants
|
6 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
NFV < 2.5
|
1 Participants
|
3 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
NFV >= 2.5
|
12 Participants
|
8 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
NVP < 2.5
|
1 Participants
|
2 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
RTV >= 2.5
|
12 Participants
|
8 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
SQV < 1.7
|
1 Participants
|
3 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
Stavudine < 1.7
|
1 Participants
|
5 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
Stavudine >= 1.7
|
12 Participants
|
6 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
TFV < 1.4
|
4 Participants
|
4 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
TFV >= 1.4
|
9 Participants
|
7 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
TPV/r < 4
|
7 Participants
|
7 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
TPV/r >= 4
|
6 Participants
|
3 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
ZDV < 1.9
|
1 Participants
|
3 Participants
|
|
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline
ZDV >= 1.9
|
12 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)Population: The PK Population was defined as all participants who received GW873140 and underwent plasma PK sampling during the study. Participants for whom plasma a PK sample was obtained and assayed were planned to be included in analyses of the PK population. Data were not collected for this outcome measure due to early termination of the study.
AUC (0- tau) GW873140 was defined as the area under the plasma concentration-time curve from time 0 to tau. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24. It was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)Population: PK Population. Data were not collected for this outcome measure due to early termination of the study.
Cmax is defined as the first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)Population: PK Population. Data were not collected for this outcome measure due to early termination of the study.
Tmax is defined as the time at which Cmax is observed, determined directly from the raw concentration-time data. Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4 (pre-dose [0 hour], 1, 2, 3, 4, 6, 8, 10 hour post-evening dose), Week 12 (pre-dose [0 hour] and 2-4 hour post-morning dose) and Week 24 (pre-dose and 2-4 hour post-morning dose)Population: PK Population. Data were not collected for this outcome measure due to early termination of the study.
Blood samples for evaluation of GW873140 plasma PK was planned to be collected from all participants at Week 4, 12, and 24. Intensive PK sampling was planned to be conducted with the enrolled participants. All participants who were not part of the intensive PK group was planned to be part of the limited PK sample group. Participants were supposed to complete a diary card with the date and time of investigational product administration of the last dose prior to clinic visits on Weeks 4, 12, and 24.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 48 of Randomized Treatment phase and up to Switch + 24 Weeks of the Open Labeled phasePopulation: ITT Population. Data for this outcome measure were not collected due to early termination of the study.
Adherence to investigational product was planned to be evaluated using pill counts of unused investigational product (blinded GW873140 or placebo, open-label GW873140 for open label phase). This assessment was planned to be conducted at each time the participant received a new (refill) supply of study medication.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Upto Week 48Population: ITT Population. Data for this outcome measure were not collected due to early termination of the study.
The HIV Symptom Index Questionnaire was planned to be used to evaluate how bothersome certain symptoms were during the conduct of this clinical study. The participant self-report instrument had 20 items, each of which asked about a specific symptom or group of related symptoms that participants might have had during the past 4 weeks and the degree to which the participant is bothered by the symptom. The symptom index comprised 32 common and HIV-specific symptoms scored in terms of presence/absence (1, 0) and severity on a 4-point scale (0 = not at all to 3 =quite a bit). Higher score represented greater severity of symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 48Population: ITT Population. Data for this outcome measure were not collected due to early termination of the study.
The EuroQol is a standardized instrument for use as a measure of health related quality of life. It consists of two pages comprising the EuroQoL 5 Dimension 5 level (EQ-5D5) descriptive system and the EQ visual analogue scale (VAS). The EQ-5D5 comprises of five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety). Each dimension comprises five levels of response (no problems, mild problems, moderate problems, moderate to extreme problems, and extreme problems). The EQ VAS records the respondents self-rated health status on a vertical graduated (0 to 100) VAS. Higher score represented greater severity of diseases.
Outcome measures
Outcome data not reported
Adverse Events
APL + OBT
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo + OBT
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
APL + OBT
n=13 participants at risk
Participants were administered APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
Placebo + OBT
n=11 participants at risk
Participants were administered matching placebo to APL tablets orally as 400 mg BID for 48 Weeks. Each dose was to be given with food. The OBT regimen was chosen by the investigator prior to randomization, based on the participant's prior treatment history, screening genotypic and phenotypic resistance testing results, and any prior resistance testing results if available. The drugs in the OBT regimen was chosen from the locally available ART and consisted between three and six drugs, one of which was RTV-boosted PI. Low-dose RTV did not count as one of the OBT regimen drugs and RTV doses of \>400 mg/day were not permitted. FDC was counted according to the number of compounds making up the FDC (e.g., combivir counted as two drugs \[lamivudine and zidovudine\], trizivir counted as three drugs, etc.). Kaletra (LPV/RTV) was counted as one drug.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
53.8%
7/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
18.2%
2/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Rectal lesion
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Gastrointestinal disorders
Stomach discomfort
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
General disorders
Fatigue
|
15.4%
2/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
General disorders
Pyrexia
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
General disorders
Chills
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
General disorders
Hernia
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
General disorders
Influenza like illness
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
General disorders
Injection site pain
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
General disorders
Injection site reaction
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
General disorders
Pain
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Acarodermatitis
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Eye infection
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Otitis media
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Nervous system disorders
Headache
|
23.1%
3/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Nervous system disorders
Migraine
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Nervous system disorders
Paraesthesia
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Psychiatric disorders
Restlessness
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
9.1%
1/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.7%
1/13 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
0.00%
0/11 • AE's were collected up to Follow-up (Week 52)
ITT Population was used.
|
Additional Information
GSK Response Center
ViiV Healthcare
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