BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

HIV Infections Clinical Trial

Official title:

A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272779
• Other study ID #: AI424-138
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2006
• Last updated: April 7, 2011
• Start date: November 2005
• Est. completion date: October 2008

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1057
• Est. completion date: October 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV RNA =5000 c/ml

Exclusion Criteria:

• Any antiretroviral therapy within 30 days prior to screening;

• Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the study;

• WOCBP using a prohibited contraceptive method

• WOCBP who are pregnant or breastfeeding;

• Women with a positive pregnancy test on enrollment or prior to study drug administration;

• Presence of a newly diagnosed HIV-Related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;

• Suspected primary (acute) HIV infection;

• Prior antiviral therapy (>30 days of NRTI and/or >7 days of non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within 30 days prior to screening; some exceptions are allowed for ARV therapy in use for Mother-to-child transmission;

• Participants with Cushing's syndrome;

• Untreated hypothyroidism or hyperthyroidism. A participant who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the thyroid stimulating hormone (TSH) performed within 30 days of screening is within normal drug range;

• Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or expected need for such therapy at the time of enrollment; or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4;

• Participants with obstructive liver disease;

• Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;

• Proven or suspected acute hepatitis in the 30 days prior to study entry;

• Intractable diarrhea (=6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;

• Inability to swallow capsules;

• Active peripheral neuropathy;

• Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease;

• Known, clinically significant cardiac conduction system disease.

• Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:

1. calculated creatine clearance <60 mL/min as estimated by the Cockcroft-Gault equation;

2. total serum lipase = 1.4 times the upper limit of normal;

3. liver enzymes (AST, ALT) = 5 times the upper limit of normal;

4. total serum bilirubin = 1.5 times the upper limit of normal.

• Hypersensitivity to any component of the formulation of study drug;

• Prohibited therapies;

• Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for study or unable to comply with the dosing requirements;

• Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• ATV
300mg Oral capsules for 96 weeks
• RTV
100mg Oral Capsules for 96 weeks
• Tenofovi-Emtricitabine (TDF/FTC) tablet
One tablet with 300 mg - 200 mg once a day for 96 weeks.
• LPV
400 mg (3 133mg capsules) BID for 96 weeks

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Argentina	Local Institution	Rosario	Santa Fe
Australia	Local Institution	Carlton	Victoria
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	South Yarra	Victoria
Austria	Local Institution	Wien
Belgium	Local Institution	Brugge
Belgium	Local Institution	Gent
Brazil	Local Institution	Campinas	Sao Paulo
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Recife	Pernambuco
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Sao Paulo
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Toronto	Ontario
Chile	Local Institution	Santiago	Metropolitana
Chile	Local Institution	Santiago De Chile	Metropolitana
Chile	Local Institution	Vina Del Mar	Valparaiso
Colombia	Local Institution	Bogota
Costa Rica	Local Institution	San Jose
Dominican Republic	Local Institution	Santo Domingo
France	Local Institution	Nice Cedex
France	Local Institution	Paris Cedex
France	Local Institution	Paris Cedex 10
France	Local Institution	Paris Cedex 13
France	Local Institution	Villejuif
Germany	Local Institution	Berlin
Germany	Local Institution	Bonn
Germany	Local Institution	Hamburg
Germany	Local Institution	Koeln
Guatemala	Local Institution	Guatemala
Hong Kong	Local Institution	Kowloon
Indonesia	Local Institution	Jakarta
Italy	Local Institution	Genova
Italy	Local Institution	Milano
Italy	Local Institution	Roma
Italy	Local Institution	Torino
Mexico	Local Institution	Chihuaha
Mexico	Local Institution	Durango
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	San Luis Potisi
Mexico	Local Institution	Zapopal	Jalisco
Mexico	Local Institution	Zapopan	Jalisco
Netherlands	Local Institution	Maastricht
Netherlands	Local Institution	Utrecht
Panama	Local Institution	Panama
Peru	Local Institution	Lima
Portugal	Local Institution	Lisboa
Portugal	Local Institution	Lisbon
Puerto Rico	Local Institution	Ponce
Puerto Rico	Local Institution	San Juan
Singapore	Local Institution	Singapore
South Africa	Local Institution	Bloemfontein	Free State
South Africa	Local Institution	Durban	Kwa Zulu Natal
South Africa	Local Institution	Johannesburg	Gauteng
South Africa	Local Institution	Meadowdale	Gauteng
South Africa	Local Institution	Mowbray	Western Cape
South Africa	Local Institution	Parow	Western Cape
South Africa	Local Institution	Port Elizabeth	Eastern Cape
South Africa	Local Institution	Rugby	Western Cape
South Africa	Local Institution	Westdene	Gauteng
Spain	Local Institution	Barcelona
Spain	Local Institution	Cordoba
Spain	Local Institution	Madrid
Spain	Local Institution	Malaga
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taipei
Thailand	Local Institution	Chiang Mai
Thailand	Local Institution	Khonkaen
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United States	Local Institution	Dallas	Texas
United States	Local Institution	Fort Worth	Texas
United States	Local Institution	Ft. Lauderdale	Florida
United States	Local Institution	Huntersville	North Carolina
United States	Local Institution	Laguna Beach	California
United States	Local Institution	Orlando	Florida
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Costa Rica,  Dominican Republic,  France,  Germany,  Guatemala,  Hong Kong,  Indonesia,  Italy,  Mexico,  Netherlands,  Panama,  Peru,  Portugal,  Puerto Rico,  Singapore,  South Africa,  Spain,  Taiwan,  Thailand,  United Kingdom, 

References & Publications (2)

Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Thiry A, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet. 2008 Aug 23;372(9639):646-55. doi: 10.1016/S0140-6736(08)61081-8. — View Citation

Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Wirtz V, Lataillade M, Absalon J, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010 Mar;53(3):323-32. doi: 10.1097/QAI.0b013e3181c990bf. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48	HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.	Baseline (Day 1) and Week 48	No
Primary	Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4	Cmax was derived from plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.	No
Primary	Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4	AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4	Cmin was derived from the plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4	Tmax was derived from the plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4	T-half was derived from the plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4	EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(µM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4	IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Cmax of RTV at Week 4	Cmax was derived from plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	AUC (0-24) of RTV at Week 4	AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Cmin of RTV at Week 4	Cmin was derived from plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Cmax of Tenofovir at Week 4	Cmax was derived from plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Cmin of Tenofovir at Week 4	Cmin was derived from plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	AUC (TAU) of Tenofovir at Week 4	AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.	No
Primary	Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96	Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.	Baseline (Day 1) and Week 96.	No
Primary	Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis	19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous].	Baseline visit	No
Primary	Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in VAT Associated With RETN_730	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).	Baseline (Day 1), Week 48, and Week 96.	No
Primary	Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980	The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).	Baseline (Day 1), Week 48, and Week 96.	No
Secondary	Number of Participants With HIV RNA < 400 c/mL at Week 48	HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.	Baseline (Day 1) and Week 48	No
Secondary	Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)	TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.	Baseline (Day 1) and Week 48	No
Secondary	Reduction of log10 HIV RNA Levels From Baseline to Week 48	Changes from baseline in log10 HIV RNA levels were calculated.	Baseline (Day 1) and Week 48	No
Secondary	Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48	Mean change from baseline in CD4 cell counts was determined.	Baseline (Day 1) and Week 48.	No
Secondary	Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48	Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change	Baseline (Day 1) and Week 48	Yes
Secondary	Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48	AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.	From baseline (Day 1) to Week 48.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)	Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48	Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 - 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48	Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48	Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48	Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48	Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48	Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48	Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.	Yes
Secondary	Mean Change in Weight From Baseline at Week 48	Mean change in body weight from baseline was determined.	Baseline (Day 1) and Week 48	Yes
Secondary	Mean Change in Body Mass Index (BMI) in Participants at Week 48	Mean change in BMI from baseline at Week 48 was determined.	Baseline (Day 1) and Week 48	No
Secondary	Mean Change in Fasting Lipid at Week 48	Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.	Baseline (Day 1) and Week 48.	No
Secondary	Mean Change in Fasting Glucose at Week 48	Mean change from baseline in fasting glucose at Week 48.	Baseline (Day 1) and Week 48.	No
Secondary	Mean Change in Fasting Insulin at Week 48	Mean change from baseline in fasting insulin at Week 48.	Baseline (Day 1) and Week 48.	No
Secondary	Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24	Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.	Baseline (Day 1) and Week 24.	No
Secondary	Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48	MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.	Baseline (Day 1) and Week 48	No
Secondary	Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)	The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.	IBS-QoL is administered at baseline (Day 1) and Week 4.	No
Secondary	Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)	The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.	IBS-QoL is administered at baseline (Day 1) and Week 12.	No
Secondary	Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)	The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.	Baseline (Day 1) and Week 24	No
Secondary	Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48	The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.	Week 48	Yes
Secondary	Number of Participants With HIV RNA < 50 c/mL) at Week 96	HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.	Baseline (Day 1) and Week 96	No
Secondary	Number of Participants With HIV RNA < 400 c/mL) at Week 96	HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.	Baseline (Day 1) and Week 96	No
Secondary	Reduction of log10 HIV RNA Levels From Baseline at Week 96	Changes from baseline in log10 HIV RNA levels were calculated.	Baseline (Day 1) and Week 96	No
Secondary	Mean Change From Baseline in CD4 Cell Count at Week 96	Mean change from baseline in CD4 count among treated participants was determined.	Baseline (Day 1) and Week 96	No
Secondary	Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96	AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.	From Day 1 through Week 96	Yes
Secondary	Mean Changes in Fasting Lipids at Week 96	Mean change from baseline in fasting lipids at Week 96 was determined.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	No
Secondary	Mean Changes in Fasting Glucose at Week 96	Mean change from baseline in fasting glucose at Week 96 was determined.	Baseline (Day 1) and Week 96	No
Secondary	Mean Changes in Fasting Insulin at Week 96	Mean change from baseline in fasting insulin at Week 96.	Baseline (Day 1) and Week 96.	No
Secondary	Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96	Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96	Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 - 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96	Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96	Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96	Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96	Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96	Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	Yes
Secondary	Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96	Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.	Yes
Secondary	Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96	Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA = 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change	Baseline (Day 1) and Week 96.	No
Secondary	Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48	Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.	DEXA scans were taken at Baseline (Day 1) and at Weeks 48.	No
Secondary	Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48	The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.	DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.	No
Secondary	Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96	The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.	Baseline (Day 1) and Week 96.	No
Secondary	Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA		Baseline (Day 1) and Week 96.	No
Secondary	Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48	Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.	DEXA scans were taken at Baseline (Day 1) and Week 48.	No
Secondary	Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96	Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.	Baseline (Day 1) and Week 96	No
Secondary	Mean Change From Baseline in Body Weight at Week 96	Mean change from baseline in weight at Week 96	Baseline (Day 1) and Week 96	No
Secondary	Mean Change From Baseline in Body Weight at Week 48	Mean change from baseline in body weight at Week 48 was determined.	Baseline (Day 1) and Week 48	No
Secondary	Mean Change From Baseline in BMI at Week 96		Baseline (Day 1) and Week 96	No
Secondary	Mean Change From Baseline in Waist Circumference at Week 96	Mean change From baseline in waist circumference at Week 96 was determined.	Baseline (Day 1) and Week 96.	No
Secondary	Mean Change From Baseline in Waist Circumference at Week 48	Mean change from baseline in waist circumference at Week 48 was determined.	Baseline (Day 1) and Week 48	No
Secondary	Mean Change From Baseline in Waist-to-hip-ratio at Week 96	Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.	Baseline (Day 1) and Week 96	No
Secondary	Mean Change From Baseline in BMI at Week 48	Mean change from baseline in BMI at Week 48 was determined.	Baseline (Day 1) and Week 48.	No
Secondary	Mean Change From Baseline in Waist-to-hip-ratio at Week 48	Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.	Baseline (Day 1) and Week 48	No
Secondary	Percentage of Participants With Lipoatrophy at Week 96	Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.	Baseline (Day 1) and Week 96	No
Secondary	Mean Changes From Baseline in Body Weight at Week 96	Mean change in body weight from baseline was determined.	Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.	No
Secondary	Mean Change From Baseline in BMI at Week 96	Mean change From baseline in BMI at Week 96 was determined.	Baseline (Day 1) and Week 96	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm