Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Compare the Efficacy and Safety of GW873140 400mg BID in Combination With a Ritonavir-containing Optimized Background Therapy (OBT) Regimen Versus Placebo Plus OBT Over 48 Weeks.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00197145

Enrollment

Registered

2005-09-20

Start date

2005-07-21

Completion date

2007-09-11

Last updated

2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus I

Keywords

HIV-1 GW873140 CCR5 antagonist experienced

Brief summary

The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5-tropic virus

Interventions

DRUGGW873140

400 mg twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HIV-infected. * Screening viral load at least 5000copies/mL. * R5-tropic only virus at screening. * Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI). * Stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening. * Able to receive a ritonavir-boosted protease inhibitor during treatment studies. * Women of childbearing potential must use specific forms of contraception.

Exclusion criteria

* Acute laboratory abnormalities. * History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility. * R5/X4-tropic, X4-tropic only, or non-phenotypeable virus at screening. * Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study. * Pregnancy or breastfeeding women. * Recent participation in an experimental drug trial. * Prior use of a CCR5 or CXCR4 antagonist. * Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness. * Current use of certain medications may exclude participation in this study. * Additional qualifying criteria and laboratory test requirements to be assessed by study physician.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48	Week 24	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.
Average Area Under the Curve Minus Baseline (AAUCMB) of Plasma HIV-1 RNA Through the Entire Study Period	Up to Week 40	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.
Number of Participants With >= 1.0 log10 Copies/mL Decrease in Plasma HIV-1 RNA From Baseline Over Time	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 phase	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.

Secondary

Measure	Time frame	Description
Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase	Baseline (Day 1), Week 12 and Week 24	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.
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	Baseline (Day 1), Week 12 and Week 24	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.
Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase	Baseline (Day 1), Week 12 and Week 24	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.
Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase	Baseline (Day 1), Week 12 and Week 24	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.
Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase	Baseline (Day 1), Week 12 and Week 24	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.
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	Baseline (Day 1), Week 12 and Week 24	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.
Change From Baseline in Haematology Parameter of Mean Corpuscle Volume (MCV) During the Randomized Treatment Phase	Baseline (Day 1), Week 12 and Week 24	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.
Change From Baseline in Haematology Parameter of Hematocrit During the Randomized Treatment Phase.	Baseline (Day 1), Week 12 and Week 24	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.
Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase	Baseline (Day 1), Week 12 and Week 24	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.
Change From Baseline in Electrocardiograph (ECG) Parameter of Heart Rate (HR) During the Randomized Treatment Phase	Baseline (Day 1), Week 4 and Week 24	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.
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	Baseline (Day 1), Week 4 and Week 24	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.
Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48	Week 24	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.
Time to Centres for Disease Control and Prevention (CDC) Class C Acquired Immune Deficiency Syndrome (AIDS)-Defining Event or Death	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	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).
Number of Participants With Development of Antiretroviral Resistance to GW873140 400 mg BID and Other Antiretroviral Drugs	Up to Follow-up (Week 52)	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.
Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Baseline (Day 1)	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).
Plasma GW873140 400 mg BID Pharmacokinetic (PK) Parameter of Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length (Tau) (AUC [0-tau]) During the Randomized Treatment Phase	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)	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.
Plasma GW873140 400 mg BID PK Parameter of Maximum Observed Plasma Concentration (Cmax) During the Randomized Treatment Phase	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)	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.
Plasma GW873140 400 mg BID PK Parameter of Time of Maximum Observed Plasma Concentration (Tmax) During the Randomized Treatment Phase	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)	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.
Plasma GW873140 400 mg BID PK Parameter of Concentration at End of Dosing Interval (Trough Concentration [Cτ]) During the Randomized Treatment Phase	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)	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.
Investigational Product Adherence Measured by Pill Counts	Up to Week 48 of Randomized Treatment phase and up to Switch + 24 Weeks of the Open Labeled phase	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.
Number of Participants Who Were Bothered by Each of Several Specific Symptoms Evaluated Using the HIV Symptom Index Questionnaire During the Randomized Treatment Phase	Upto Week 48	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.
Number of Participants With the Impact on Health Related Quality of Life Measured by Euro Quality of Life (Qol) Questionnaire During the Randomized Treatment Phase	Up to Week 48	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.
Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase	Baseline (Day 1), Week 12, Week 24 and Week 40	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.
Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation	Up to Follow-up (Week 52)	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.
Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Up to Week 40	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.

Countries

Canada, Puerto Rico, United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
APL + OBT 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.	13
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.	11
Total	24

Withdrawals & dropouts

Period	Reason	FG000	FG001
Period 1: Randomized Treatment Phase	Other	2	2
Period 1: Randomized Treatment Phase	Sponsor terminated study	10	8
Period 1: Randomized Treatment Phase	Withdrawal by Subject	1	1
Period 2 : Open Label Phase	Availability of alternative ART	2	0
Period 2 : Open Label Phase	Insufficient viral load response	1	0
Period 2 : Open Label Phase	Other	1	0
Period 2 : Open Label Phase	Protocol defined virological failure	3	0
Period 2 : Open Label Phase	Were ongoing till data freeze	3	0

Baseline characteristics

Characteristic	Placebo + OBT	Total	APL + OBT
Age, Continuous	44.5 Years STANDARD_DEVIATION 5.68	45.8 Years STANDARD_DEVIATION 6.42	46.8 Years STANDARD_DEVIATION 7.03
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	6 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	8 Participants	18 Participants	10 Participants
Sex: Female, Male Female	2 Participants	4 Participants	2 Participants
Sex: Female, Male Male	9 Participants	20 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 13	0 / 11
other Total, other adverse events	11 / 13	5 / 11
serious Total, serious adverse events	0 / 13	0 / 11

Outcome results

Primary

Average Area Under the Curve Minus Baseline (AAUCMB) of Plasma HIV-1 RNA Through the Entire Study Period

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.

Time frame: Up to Week 40

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (MEAN)	Dispersion
APL + OBT	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 0.99
Placebo + OBT	Average Area Under the Curve Minus Baseline (AAUCMB) of Plasma HIV-1 RNA Through the Entire Study Period	-1.14 Log10 copies/mL	Standard Deviation 0.766

Primary

Number of Participants With >= 1.0 log10 Copies/mL Decrease in Plasma HIV-1 RNA From Baseline Over Time

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.

Time frame: 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 phase

Population: ITT Population. Data were not collected for this outcome measure due to early termination of the study.

Primary

Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48

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.

Time frame: Week 24

Population: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
APL + OBT	Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48	5 Participants
Placebo + OBT	Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48	0 Participants

Secondary

Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase

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.

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase	Week 12	1.385 Gram (g)/L	Standard Deviation 2.6627
APL + OBT	Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase	Week 24	2.000 Gram (g)/L	Standard Deviation 3.559
Placebo + OBT	Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase	Week 12	3.750 Gram (g)/L	Standard Deviation 2.5

Secondary

Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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
APL + OBT	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
APL + OBT	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 31.079
APL + OBT	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
Placebo + OBT	Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase	Creatinine, Week 12	13.000 Micromole (UMOL)/L	Standard Deviation 11.1056
Placebo + OBT	Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase	Total Bilirubin, Week 12	-0.500 Micromole (UMOL)/L	Standard Deviation 6.8069

Secondary

Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase	Week 12	6.636 U/L	Standard Deviation 8.4531
APL + OBT	Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase	Week 24	12.571 U/L	Standard Deviation 20.3867
Placebo + OBT	Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase	Week 12	0.000 U/L	Standard Deviation 4.2426

Secondary

Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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 553.425
APL + OBT	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 15.933
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
Placebo + OBT	Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase	ALT, Week 12	9.250 International unit per liter (IU/L)	Standard Deviation 18.8569
Placebo + OBT	Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase	AST, Week 12	4.750 International unit per liter (IU/L)	Standard Deviation 8.4212
Placebo + OBT	Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase	CK, Week 12	37.250 International unit per liter (IU/L)	Standard Deviation 78.991
Placebo + OBT	Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase	ALP, Week 12	25.750 International unit per liter (IU/L)	Standard Deviation 18.9275

Secondary

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

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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
APL + OBT	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 0.234
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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 3.645
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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 1.573
APL + OBT	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 1.976
APL + OBT	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
Placebo + OBT	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	-0.100 Millimole (MMOL)/L	—
Placebo + OBT	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	-1.250 Millimole (MMOL)/L	Standard Deviation 4.1932
Placebo + OBT	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	0.375 Millimole (MMOL)/L	Standard Deviation 2.9545
Placebo + OBT	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	-0.500 Millimole (MMOL)/L	—
Placebo + OBT	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	-0.240 Millimole (MMOL)/L	—
Placebo + OBT	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	-0.700 Millimole (MMOL)/L	—
Placebo + OBT	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	-0.225 Millimole (MMOL)/L	Standard Deviation 0.3304
Placebo + OBT	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	-2.500 Millimole (MMOL)/L	Standard Deviation 2.6458
Placebo + OBT	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	1.150 Millimole (MMOL)/L	Standard Deviation 1.3964
Placebo + OBT	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	-2.500 Millimole (MMOL)/L	Standard Deviation 3.6968

Secondary

Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase

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.

Time frame: Baseline (Day 1), Week 12, Week 24 and Week 40

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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
APL + OBT	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
APL + OBT	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
Placebo + OBT	Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase	Week 12	80.500 Cells/Cubic millimeter (mm^3)	Standard Deviation 177.4838

Secondary

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

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.

Time frame: Baseline (Day 1), Week 4 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
Placebo + OBT	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	-52.1 Millisecond (msec)	Standard Deviation 128.19
Placebo + OBT	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	10.2 Millisecond (msec)	Standard Deviation 14.06
Placebo + OBT	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	15.4 Millisecond (msec)	Standard Deviation 14.64
Placebo + OBT	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	1.2 Millisecond (msec)	Standard Deviation 28.81
Placebo + OBT	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	0.2 Millisecond (msec)	Standard Deviation 15.98
Placebo + OBT	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	0.4 Millisecond (msec)	Standard Deviation 7.13

Secondary

Change From Baseline in Electrocardiograph (ECG) Parameter of Heart Rate (HR) During the Randomized Treatment Phase

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.

Time frame: Baseline (Day 1), Week 4 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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
APL + OBT	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
Placebo + OBT	Change From Baseline in Electrocardiograph (ECG) Parameter of Heart Rate (HR) During the Randomized Treatment Phase	Week 4	4.3 Beats per minute (Bpm)	Standard Deviation 11.54

Secondary

Change From Baseline in Haematology Parameter of Hematocrit During the Randomized Treatment Phase.

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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
APL + OBT	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
Placebo + OBT	Change From Baseline in Haematology Parameter of Hematocrit During the Randomized Treatment Phase.	Week 12	0.026 Percentage of red blood cells	Standard Deviation 0.0099

Secondary

Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase	Week 12	4.923 g/L	Standard Deviation 9.9621
APL + OBT	Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase	Week 24	-4.000 g/L	Standard Deviation 10.2144
Placebo + OBT	Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase	Week 12	6.500 g/L	Standard Deviation 4.9497

Secondary

Change From Baseline in Haematology Parameter of Mean Corpuscle Volume (MCV) During the Randomized Treatment Phase

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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
APL + OBT	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
Placebo + OBT	Change From Baseline in Haematology Parameter of Mean Corpuscle Volume (MCV) During the Randomized Treatment Phase	Week 12	-1.500 Femtoliter (FL)	Standard Deviation 4.9497

Secondary

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

Time frame: Baseline (Day 1), Week 12 and Week 24

Population: ITT Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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 1.013
APL + OBT	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
APL + OBT	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
Placebo + OBT	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	0.090 Giga cells (GI)/L	Standard Deviation 0.1697
Placebo + OBT	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	-0.095 Giga cells (GI)/L	Standard Deviation 0.2758
Placebo + OBT	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	-0.005 Giga cells (GI)/L	Standard Deviation 0.0212
Placebo + OBT	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	-3.500 Giga cells (GI)/L	Standard Deviation 33.234
Placebo + OBT	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	-0.900 Giga cells (GI)/L	Standard Deviation 1.1314
Placebo + OBT	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	0.050 Giga cells (GI)/L	Standard Deviation 0.297
Placebo + OBT	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	-0.935 Giga cells (GI)/L	Standard Deviation 0.3889

Secondary

Investigational Product Adherence Measured by Pill Counts

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.

Time frame: Up to Week 48 of Randomized Treatment phase and up to Switch + 24 Weeks of the Open Labeled phase

Population: ITT Population. Data for this outcome measure were not collected due to early termination of the study.

Secondary

Number of Participants Who Were Bothered by Each of Several Specific Symptoms Evaluated Using the HIV Symptom Index Questionnaire During the Randomized Treatment Phase

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.

Time frame: Upto Week 48

Population: ITT Population. Data for this outcome measure were not collected due to early termination of the study.

Secondary

Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline

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).

Time frame: Baseline (Day 1)

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ATV/r >= 5.2	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	AMP < 2	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ABC >= 4.5	13 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	AMP >= 2	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	APL < 2.5	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	APL >= 2.5	0 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ATV >= 2.3	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	IDV < 2.1	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	LPV/r < 10	3 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	IDV >= 2.1	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	NVP < 2.5	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	IDV/r < 10	2 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ATV/r < 5.2	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	IDV/r >= 10	11 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	NVP >= 2.5	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Lamivudine < 3.5	0 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	DLV < 2.5	3 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Lamivudine >= 3.5	13 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ATV < 2.3	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	DDI < 1.3	0 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	LPV/r >= 10	10 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	DLV >= 2.5	10 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	NFV < 2.5	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	DDI >= 1.3	13 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	NFV >= 2.5	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Enfuvirtide < 2.5	2 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	EFV < 2.5	2 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	TFV >= 1.4	9 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	EFV >= 2.5	11 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	RTV >= 2.5	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Emtricitabine < 3.5	0 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	SQV < 1.7	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Enfuvirtide >= 2.5	9 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	SQV >= 1.7	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Stavudine < 1.7	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Stavudine >= 1.7	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	TFV < 1.4	4 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Emtricitabine >= 3.5	13 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	TPV/r >= 4	6 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	TPV/r < 4	7 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ZDV < 1.9	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	RTV < 2.5	1 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ZDV >= 1.9	12 Participants
APL + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ABC < 4.5	0 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ZDV >= 1.9	8 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ABC < 4.5	4 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ATV/r >= 5.2	6 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	DLV < 2.5	4 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	AMP >= 2	7 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	APL < 2.5	9 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	SQV >= 1.7	8 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Stavudine < 1.7	5 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Stavudine >= 1.7	6 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	TPV/r < 4	7 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	TPV/r >= 4	3 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ABC >= 4.5	7 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ATV < 2.3	3 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ATV >= 2.3	8 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	EFV >= 2.5	9 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ATV/r < 5.2	5 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	DLV >= 2.5	7 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	DDI < 1.3	5 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	DDI >= 1.3	6 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	EFV < 2.5	2 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Emtricitabine < 3.5	3 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Emtricitabine >= 3.5	8 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Enfuvirtide < 2.5	7 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Enfuvirtide >= 2.5	2 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	AMP < 2	4 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	APL >= 2.5	0 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	IDV < 2.1	3 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	IDV >= 2.1	8 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	IDV/r < 10	7 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	IDV/r >= 10	4 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Lamivudine < 3.5	4 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	Lamivudine >= 3.5	7 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	LPV/r < 10	6 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	LPV/r >= 10	5 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	NFV < 2.5	3 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	NFV >= 2.5	8 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	NVP < 2.5	2 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	NVP >= 2.5	9 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	RTV < 2.5	3 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	RTV >= 2.5	8 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	SQV < 1.7	3 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	TFV < 1.4	4 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	TFV >= 1.4	7 Participants
Placebo + OBT	Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline	ZDV < 1.9	3 Participants

Secondary

Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation

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.

Time frame: Up to Follow-up (Week 52)

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
APL + OBT	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
Placebo + OBT	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
Placebo + OBT	Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation	Any AE	5 Participants
Placebo + OBT	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
Placebo + OBT	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
Placebo + OBT	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	2 Participants

Secondary

Number of Participants With Development of Antiretroviral Resistance to GW873140 400 mg BID and Other Antiretroviral Drugs

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.

Time frame: Up to Follow-up (Week 52)

Population: Virologic Failure Population was defined as the number of participants with protocol defined virologic failure criteria.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
APL + OBT	Number of Participants With Development of Antiretroviral Resistance to GW873140 400 mg BID and Other Antiretroviral Drugs	2 Participants
Placebo + OBT	Number of Participants With Development of Antiretroviral Resistance to GW873140 400 mg BID and Other Antiretroviral Drugs	1 Participants

Secondary

Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48

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.

Time frame: Week 24

Population: ITT Population. The analysis was an observed analysis and only participants with data available at the indicated timepoints were included.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
APL + OBT	Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48	5 Participants
Placebo + OBT	Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48	0 Participants

Secondary

Number of Participants With the Impact on Health Related Quality of Life Measured by Euro Quality of Life (Qol) Questionnaire During the Randomized Treatment Phase

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.

Time frame: Up to Week 48

Population: ITT Population. Data for this outcome measure were not collected due to early termination of the study.

Secondary

Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline

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.

Time frame: Up to Week 40

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Cholesterol, Grade 1	0 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Total Bilirubin, Grade 2	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	CK, Grade 3	2 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Total Bilirubin, Grade 4	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Creatinine, Grade 1	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Triglycerides, Grade 2	0 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Glucose, Grade 1	3 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Triglycerides, Grade 3	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Cholesterol, Grade 2	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Alanine Amino Transferase (ALT), Grade 1	0 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	ALT, Grade 2	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Glucose, Grade 2	3 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Albumin, Grade 2	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Aspartate Amino Transferase (AST), Grade 1	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Alkaline Phosphatase (ALP), Grade 1	2 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Lipase, Grade 1	3 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	AST, Grade 2	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Creatine Kinase (CK), Grade 1	0 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Lipase, Grade 2	1 Participants
APL + OBT	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
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Potassium, Grade 4	0 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	CK, Grade 2	1 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Glucose, Grade 3	1 Participants
APL + OBT	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
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Sodium, Grade 1	3 Participants
APL + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Total Bilirubin, Grade 1	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Sodium, Grade 1	2 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Alkaline Phosphatase (ALP), Grade 1	3 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	AST, Grade 2	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Cholesterol, Grade 2	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Creatine Kinase (CK), Grade 1	1 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	CK, Grade 2	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Glucose, Grade 1	3 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Glucose, Grade 3	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Lipase, Grade 1	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Lipase, Grade 2	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Potassium, Grade 4	1 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Total Bilirubin, Grade 1	1 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Total Bilirubin, Grade 2	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Total Bilirubin, Grade 4	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Triglycerides, Grade 2	2 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Triglycerides, Grade 3	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	ALT, Grade 2	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Albumin, Grade 2	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Aspartate Amino Transferase (AST), Grade 1	2 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Carbon Dioxide content/Bicarbonate (CO2), Grade 1	3 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Cholesterol, Grade 1	1 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	CK, Grade 3	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Creatinine, Grade 1	2 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Glucose, Grade 2	2 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Low Density lipoprotein (LDL) Cholesterol, Grade 2	0 Participants
Placebo + OBT	Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline	Alanine Amino Transferase (ALT), Grade 1	1 Participants

Secondary

Plasma GW873140 400 mg BID Pharmacokinetic (PK) Parameter of Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length (Tau) (AUC [0-tau]) During the Randomized Treatment Phase

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.

Time frame: 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.

Secondary

Plasma GW873140 400 mg BID PK Parameter of Concentration at End of Dosing Interval (Trough Concentration [Cτ]) During the Randomized Treatment Phase

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.

Time frame: 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.

Secondary

Plasma GW873140 400 mg BID PK Parameter of Maximum Observed Plasma Concentration (Cmax) During the Randomized Treatment Phase

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.

Time frame: 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.

Secondary

Plasma GW873140 400 mg BID PK Parameter of Time of Maximum Observed Plasma Concentration (Tmax) During the Randomized Treatment Phase

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.

Time frame: 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.

Secondary

Time to Centres for Disease Control and Prevention (CDC) Class C Acquired Immune Deficiency Syndrome (AIDS)-Defining Event or Death

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).

Time frame: 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

Population: ITT Population. Data were not collected for this outcome measure due to early termination of the study.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects

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Average Area Under the Curve Minus Baseline (AAUCMB) of Plasma HIV-1 RNA Through the Entire Study Period

Number of Participants With >= 1.0 log10 Copies/mL Decrease in Plasma HIV-1 RNA From Baseline Over Time

Number of Participants With Plasma HIV-1 RNA <400 Copies Per Milliliter (Copies /mL) at Week 24 and 48

Change From Baseline in Chemistry Parameter of Albumin During the Randomized Treatment Phase

Change From Baseline in Chemistry Parameter of Creatinine and Total Bilirubin During the Randomized Treatment Phase

Change From Baseline in Chemistry Parameter of Lipase During the Randomized Treatment Phase

Change From Baseline in Chemistry Parameters of ALT, ALP, AST and CK During the Randomized Treatment Phase

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

Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Counts During the Randomized Treatment Phase

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

Change From Baseline in Electrocardiograph (ECG) Parameter of Heart Rate (HR) During the Randomized Treatment Phase

Change From Baseline in Haematology Parameter of Hematocrit During the Randomized Treatment Phase.

Change From Baseline in Haematology Parameter of Hemoglobin During the Randomized Treatment Phase

Change From Baseline in Haematology Parameter of Mean Corpuscle Volume (MCV) During the Randomized Treatment Phase

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

Investigational Product Adherence Measured by Pill Counts

Number of Participants Who Were Bothered by Each of Several Specific Symptoms Evaluated Using the HIV Symptom Index Questionnaire During the Randomized Treatment Phase

Number of Participants With 50% Inhibitory Concentration (IC50) Fold Resistance at Baseline

Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), Death, Drug-related AE and AE Leading to Treatment Discontinuation

Number of Participants With Development of Antiretroviral Resistance to GW873140 400 mg BID and Other Antiretroviral Drugs

Number of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24 and 48

Number of Participants With the Impact on Health Related Quality of Life Measured by Euro Quality of Life (Qol) Questionnaire During the Randomized Treatment Phase

Number of Participants With Treatment Emergent Laboratory Abnormalities for Chemistry Data at Any Visit Post-Baseline

Plasma GW873140 400 mg BID Pharmacokinetic (PK) Parameter of Area Under the Plasma Concentration-time Curve During One Dosing Interval of Length (Tau) (AUC [0-tau]) During the Randomized Treatment Phase

Plasma GW873140 400 mg BID PK Parameter of Concentration at End of Dosing Interval (Trough Concentration [Cτ]) During the Randomized Treatment Phase

Plasma GW873140 400 mg BID PK Parameter of Maximum Observed Plasma Concentration (Cmax) During the Randomized Treatment Phase

Plasma GW873140 400 mg BID PK Parameter of Time of Maximum Observed Plasma Concentration (Tmax) During the Randomized Treatment Phase

Time to Centres for Disease Control and Prevention (CDC) Class C Acquired Immune Deficiency Syndrome (AIDS)-Defining Event or Death