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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00272779
• Collaborator: (none)
• Enrollment: 1,057
• Locations: 83
• Arms: 2
• Duration (Months): 35
• Patients Per Site: 12.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: ATV; Drug: RTV; Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet; Drug: LPV	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1057 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Atazanavir (ATV) + Ritonovir (RTV) Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.	Drug: ATV; 300mg Oral capsules for 96 weeks; Other Names: Atazanavir Reyataz BMS-232632 ; Drug: RTV; 100mg Oral Capsules for 96 weeks; Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet; One tablet with 300 mg - 200 mg once a day for 96 weeks.
Active Comparator: Lopinavir (LPV) + RTV Participants were administered an oral dose of LPV 400 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of LPV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.	Drug: RTV; 100mg Oral Capsules for 96 weeks; Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet; One tablet with 300 mg - 200 mg once a day for 96 weeks.; Drug: LPV; 400 mg (3 133mg capsules) BID for 96 weeks

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48 [Baseline (Day 1) and 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.

2. Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF 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 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.]

   Cmax was derived from plasma concentration versus time data.

3. 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 [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.]

   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.

4. Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF 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.]

   Cmin was derived from the plasma concentration versus time data.

5. 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 [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.]

   Tmax was derived from the plasma concentration versus time data.

6. Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF 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.]

   T-half was derived from the plasma concentration versus time data.

7. Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV 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.]

   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).

8. Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV 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.]

   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.

9. Cmax of RTV 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.]

   Cmax was derived from plasma concentration versus time data.

10. AUC (0-24) of RTV 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.]

    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.

11. Cmin of RTV 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.]

    Cmin was derived from plasma concentration versus time data.

12. Cmax of Tenofovir 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.]

    Cmax was derived from plasma concentration versus time data.

13. Cmin of Tenofovir 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.]

    Cmin was derived from plasma concentration versus time data.

14. AUC (TAU) of Tenofovir 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.]

    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.

15. Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96 [Baseline (Day 1) and 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.

16. Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis [Baseline visit]

    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].

17. Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097 [Baseline (Day 1), Week 48, and Week 96.]

    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.

18. Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097 [Baseline (Day 1), Week 48, and Week 96.]

    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.

19. Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265 [Baseline (Day 1), Week 48, and Week 96.]

    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.

20. Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598 [Baseline (Day 1), Week 48, and Week 96.]

    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.

21. Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R [Baseline (Day 1), Week 48, and Week 96.]

    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.

22. Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734 [Baseline (Day 1), Week 48, and Week 96.]

    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.

23. Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C [Baseline (Day 1), Week 48, and Week 96.]

    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.

24. Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309 [Baseline (Day 1), Week 48, and Week 96.]

    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.

25. Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679 [Baseline (Day 1), Week 48, and Week 96.]

    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.

26. Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980 [Baseline (Day 1), Week 48, and Week 96.]

    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).

27. Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842 [Baseline (Day 1), Week 48, and Week 96.]

    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).

28. Mean Change From Baseline in VAT Associated With RETN_730 [Baseline (Day 1), Week 48, and Week 96.]

    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).

29. Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980 [Baseline (Day 1), Week 48, and Week 96.]

    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).

Secondary Outcome Measures

1. Number of Participants With HIV RNA < 400 c/mL at Week 48 [Baseline (Day 1) and 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.

2. 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) [Baseline (Day 1) and Week 48]

   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.

3. Reduction of log10 HIV RNA Levels From Baseline to Week 48 [Baseline (Day 1) and Week 48]

   Changes from baseline in log10 HIV RNA levels were calculated.

4. Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 [Baseline (Day 1) and Week 48.]

   Mean change from baseline in CD4 cell counts was determined.

5. Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 [Baseline (Day 1) and 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

6. Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48 [From baseline (Day 1) to 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.

7. 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) [At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.]

   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.

8. Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48 [At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 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.

9. Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 [At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 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.

10. Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 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.

11. Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 [At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 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.

12. Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48 [At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 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.

13. Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48 [At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 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.

14. Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48 [At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 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.

15. Mean Change in Weight From Baseline at Week 48 [Baseline (Day 1) and Week 48]

    Mean change in body weight from baseline was determined.

16. Mean Change in Body Mass Index (BMI) in Participants at Week 48 [Baseline (Day 1) and Week 48]

    Mean change in BMI from baseline at Week 48 was determined.

17. Mean Change in Fasting Lipid at Week 48 [Baseline (Day 1) and 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.

18. Mean Change in Fasting Glucose at Week 48 [Baseline (Day 1) and Week 48.]

    Mean change from baseline in fasting glucose at Week 48.

19. Mean Change in Fasting Insulin at Week 48 [Baseline (Day 1) and Week 48.]

    Mean change from baseline in fasting insulin at Week 48.

20. Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 [Baseline (Day 1) and 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.

21. Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 [Baseline (Day 1) and 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.

22. Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) [IBS-QoL is administered at baseline (Day 1) and Week 4.]

    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.

23. Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) [IBS-QoL is administered at baseline (Day 1) and Week 12.]

    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.

24. 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) [Baseline (Day 1) and Week 24]

    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.

25. Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48 [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.

26. Number of Participants With HIV RNA < 50 c/mL) at Week 96 [Baseline (Day 1) and 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.

27. Number of Participants With HIV RNA < 400 c/mL) at Week 96 [Baseline (Day 1) and 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.

28. Reduction of log10 HIV RNA Levels From Baseline at Week 96 [Baseline (Day 1) and Week 96]

    Changes from baseline in log10 HIV RNA levels were calculated.

29. Mean Change From Baseline in CD4 Cell Count at Week 96 [Baseline (Day 1) and Week 96]

    Mean change from baseline in CD4 count among treated participants was determined.

30. Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 [From Day 1 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.

31. Mean Changes in Fasting Lipids at Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.]

    Mean change from baseline in fasting lipids at Week 96 was determined.

32. Mean Changes in Fasting Glucose at Week 96 [Baseline (Day 1) and Week 96]

    Mean change from baseline in fasting glucose at Week 96 was determined.

33. Mean Changes in Fasting Insulin at Week 96 [Baseline (Day 1) and Week 96.]

    Mean change from baseline in fasting insulin at Week 96.

34. Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 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.

35. Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 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.

36. Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 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.

37. Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 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.

38. Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 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.

39. Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 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.

40. Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 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.

41. Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96 [At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 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.

42. Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 [Baseline (Day 1) and 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

43. Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48 [DEXA scans were taken at Baseline (Day 1) and at Weeks 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.

44. Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48 [DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 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.

45. Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96 [Baseline (Day 1) and 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.

46. 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.]

47. Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48 [DEXA scans were taken at Baseline (Day 1) and 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.

48. Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96 [Baseline (Day 1) and 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.

49. Mean Change From Baseline in Body Weight at Week 96 [Baseline (Day 1) and Week 96]

    Mean change from baseline in weight at Week 96

50. Mean Change From Baseline in Body Weight at Week 48 [Baseline (Day 1) and Week 48]

    Mean change from baseline in body weight at Week 48 was determined.

51. Mean Change From Baseline in BMI at Week 96 [Baseline (Day 1) and Week 96]

52. Mean Change From Baseline in Waist Circumference at Week 96 [Baseline (Day 1) and Week 96.]

    Mean change From baseline in waist circumference at Week 96 was determined.

53. Mean Change From Baseline in Waist Circumference at Week 48 [Baseline (Day 1) and Week 48]

    Mean change from baseline in waist circumference at Week 48 was determined.

54. Mean Change From Baseline in Waist-to-hip-ratio at Week 96 [Baseline (Day 1) and Week 96]

    Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.

55. Mean Change From Baseline in BMI at Week 48 [Baseline (Day 1) and Week 48.]

    Mean change from baseline in BMI at Week 48 was determined.

56. Mean Change From Baseline in Waist-to-hip-ratio at Week 48 [Baseline (Day 1) and Week 48]

    Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.

57. Percentage of Participants With Lipoatrophy at Week 96 [Baseline (Day 1) and 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.

58. Mean Changes From Baseline in Body Weight at Week 96 [Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.]

    Mean change in body weight from baseline was determined.

59. Mean Change From Baseline in BMI at Week 96 [Baseline (Day 1) and Week 96]

    Mean change From baseline in BMI at Week 96 was determined.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Phoenix	Arizona	United States
2	Local Institution	Laguna Beach	California	United States
3	Local Institution	Washington	District of Columbia	United States
4	Local Institution	Ft. Lauderdale	Florida	United States
5	Local Institution	Orlando	Florida	United States
6	Local Institution	Huntersville	North Carolina	United States
7	Local Institution	Dallas	Texas	United States
8	Local Institution	Fort Worth	Texas	United States
9	Local Institution	Capital Federal	Buenos Aires	Argentina
10	Local Institution	Mar Del Plata	Buenos Aires	Argentina
11	Local Institution	Rosario	Santa Fe	Argentina
12	Local Institution	Buenos Aires		Argentina
13	Local Institution	Cordoba		Argentina
14	Local Institution	Darlinghurst	New South Wales	Australia
15	Local Institution	Carlton	Victoria	Australia
16	Local Institution	South Yarra	Victoria	Australia
17	Local Institution	Wien		Austria
18	Local Institution	Brugge		Belgium
19	Local Institution	Gent		Belgium
20	Local Institution	Curitiba	Parana	Brazil
21	Local Institution	Recife	Pernambuco	Brazil
22	Local Institution	Campinas	Sao Paulo	Brazil
23	Local Institution	Rio De Janeiro		Brazil
24	Local Institution	Sao Paulo		Brazil
25	Local Institution	Toronto	Ontario	Canada
26	Local Institution	Montreal	Quebec	Canada
27	Local Institution	Santiago De Chile	Metropolitana	Chile
28	Local Institution	Santiago	Metropolitana	Chile
29	Local Institution	Vina Del Mar	Valparaiso	Chile
30	Local Institution	Bogota		Colombia
31	Local Institution	San Jose		Costa Rica
32	Local Institution	Santo Domingo		Dominican Republic
33	Local Institution	Nice Cedex		France
34	Local Institution	Paris Cedex 10		France
35	Local Institution	Paris Cedex 13		France
36	Local Institution	Paris Cedex		France
37	Local Institution	Villejuif		France
38	Local Institution	Berlin		Germany
39	Local Institution	Bonn		Germany
40	Local Institution	Hamburg		Germany
41	Local Institution	Koeln		Germany
42	Local Institution	Guatemala		Guatemala
43	Local Institution	Kowloon		Hong Kong
44	Local Institution	Jakarta		Indonesia
45	Local Institution	Genova		Italy
46	Local Institution	Milano		Italy
47	Local Institution	Roma		Italy
48	Local Institution	Torino		Italy
49	Local Institution	Mexico	Distrito Federal	Mexico
50	Local Institution	Guadalajara	Jalisco	Mexico
51	Local Institution	Zapopal	Jalisco	Mexico
52	Local Institution	Zapopan	Jalisco	Mexico
53	Local Institution	Chihuaha		Mexico
54	Local Institution	Durango		Mexico
55	Local Institution	San Luis Potisi		Mexico
56	Local Institution	Maastricht		Netherlands
57	Local Institution	Utrecht		Netherlands
58	Local Institution	Panama		Panama
59	Local Institution	Lima		Peru
60	Local Institution	Lisboa		Portugal
61	Local Institution	Lisbon		Portugal
62	Local Institution	Ponce		Puerto Rico
63	Local Institution	San Juan		Puerto Rico
64	Local Institution	Singapore		Singapore
65	Local Institution	Port Elizabeth	Eastern Cape	South Africa
66	Local Institution	Bloemfontein	Free State	South Africa
67	Local Institution	Johannesburg	Gauteng	South Africa
68	Local Institution	Meadowdale	Gauteng	South Africa
69	Local Institution	Westdene	Gauteng	South Africa
70	Local Institution	Durban	Kwa Zulu Natal	South Africa
71	Local Institution	Mowbray	Western Cape	South Africa
72	Local Institution	Parow	Western Cape	South Africa
73	Local Institution	Rugby	Western Cape	South Africa
74	Local Institution	Barcelona		Spain
75	Local Institution	Cordoba		Spain
76	Local Institution	Madrid		Spain
77	Local Institution	Malaga		Spain
78	Local Institution	Kaohsiung		Taiwan
79	Local Institution	Taipei		Taiwan
80	Local Institution	Chiang Mai		Thailand
81	Local Institution	Khonkaen		Thailand
82	Local Institution	London	Greater London	United Kingdom
83	Local Institution	Manchester	Greater Manchester	United Kingdom

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00272779
• Other Study ID Numbers: AI424-138
• First Posted: Jan 9, 2006
• Last Update Posted: May 9, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: HIV; Treatment Naive
• Additional relevant MeSH terms: HIV Infections; Emtricitabine; Atazanavir Sulfate

Study Results

Participant Flow

Pre-assignment Detail	Of 1057 HIV-infected participants, 174 participants were not randomized to receive study drug, the main reason being that they did not meet the study criteria (133/174; 76%). 441 randomized to ATV received any drug and 437 randomized to LPV received any drug. 438 and 440 participants randomized to ATV and LPV, respectively, received correct drug.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Period Title: Baseline Through Week 48
STARTED	440	443
RECEIVED ANY TREATMENT	441	437
TREATED AS RANDOMIZED	438	440
Discontinued Before Week 48	39	58
Discontinued on or After Week 48	14	14
STILL ON TREATMENT	385	368
COMPLETED	0	0
NOT COMPLETED	440	443
Period Title: Baseline Through Week 48
STARTED	440	443
RECEIVED ANY TREATMENT	441	437
COMPLETED	301	307
NOT COMPLETED	139	136

Baseline Characteristics

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	Total
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.	Total of all reporting groups
Overall Participants	440	443	883
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36 (9.1)	37 (10.0)	36 (9.6)
Sex: Female, Male (Count of Participants)
Female	138 31.4%	139 31.4%	277 31.4%
Male	302 68.6%	304 68.6%	606 68.6%
Race/Ethnicity, Customized (participants) [Number]
Asian	42 9.5%	41 9.3%	83 9.4%
Black or African American	83 18.9%	80 18.1%	163 18.5%
White	207 47%	221 49.9%	428 48.5%
Hispanic/Latino	7 1.6%	6 1.4%	13 1.5%
Mestizo	71 16.1%	68 15.3%	139 15.7%
Mixed race	30 6.8%	27 6.1%	57 6.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
Description	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.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) analysis. Participants received treatment assignment from the central randomization center. In this analysis, participants who did not complete the study were counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under non-completers.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	440	443
Number [Participants]	343 78%	338 76.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference Estimate
	Estimated Value	1.7
	Confidence Interval	(2-Sided) 95%; -3.8 to 7.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With HIV RNA < 400 c/mL at Week 48
Description	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.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under Non-completers.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	440	443
Number [Participants]	377 85.7%	365 82.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference Estimate
	Estimated Value	3.3
	Confidence Interval	(2-Sided) 95%; -1.5 to 8.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	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)
Description	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.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Efficacy analyses of the treatment period are based on randomized population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	440	443
Number [Participants]	377 85.7%	363 81.9%

4. Secondary Outcome

Title	Reduction of log10 HIV RNA Levels From Baseline to Week 48
Description	Changes from baseline in log10 HIV RNA levels were calculated.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

All treated participants with data for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	397	379
Mean (Standard Error) [c/mL]	-3.09 (0.042)	-3.13 (0.037)

5. Secondary Outcome

Title	Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
Description	Mean change from baseline in CD4 cell counts was determined.
Time Frame	Baseline (Day 1) and Week 48.

Outcome Measure Data

Analysis Population Description

All treated participants with data for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	370	363
Mean (Standard Error) [c/mm^3]	203 (7.1)	219 (7.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference Estimate
	Estimated Value	-16.4
	Confidence Interval	(2-Sided) 95%; -35.9 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48
Description	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
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	440	443
Virologic Failure, Week 48 (HIV RNA >= 400 c/mL)	27 6.1%	26 5.9%
Paired Genotypes (n = 27, 26)	17 3.9%	15 3.4%
Paired Phenotypes (n= 27, 26)	18 4.1%	16 3.6%
IAS-defined major PI substitutions (n = 17, 15)	1 0.2%	0 0%
Other IAS-defined PI substitutions (n = 17, 15)	6 1.4%	2 0.5%
PI phenotypic resistance (ATV/RTV FC>5.2 (n=18,16)	1 0.2%	0 0%
PI phenotypic resistance (LPV/RTV FC >9 (n=18, 16)	0 0%	0 0%
PI phenotypic resistance (Other PIs )(n=18, 16)	4 0.9%	4 0.9%
RTI Substitutions , TAMS (n= 17,15)	1 0.2%	1 0.2%
RTI Substitutions , M184V (n = 17,15)	3 0.7%	3 0.7%
RTI phenotypic resistance, FTC FC>3.5 (n = 18, 16)	4 0.9%	3 0.7%
RTI phenotypic resistance, TDF FC >1.4(n = 18, 16)	0 0%	1 0.2%
RTI phenotypic resistance, Other NRTIs(n = 18, 16)	5 1.1%	5 1.1%

7. Secondary Outcome

Title	Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48
Description	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.
Time Frame	From baseline (Day 1) to Week 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Deaths	6 1.4%	6 1.4%
Other SAEs	51 11.6%	42 9.5%
AEs	400 90.9%	399 90.1%
AEs leading to discontinuation	11 2.5%	15 3.4%

8. Secondary Outcome

Title	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)
Description	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.
Time Frame	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Hematocrit (n= 434, 431)	0 0%	6 1.4%
Hemoglobin (n= 434, 431)	2 0.5%	6 1.4%
INR (n= 435, 431)	6 1.4%	11 2.5%
Neutrophils (n = 434, 431)	14 3.2%	3 0.7%
Platelets ( n= 433, 430)	5 1.1%	1 0.2%
PT (n = 435, 431)	6 1.4%	16 3.6%
WBC (n = 434, 431)	0 0%	0 0%

9. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48
Description	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.
Time Frame	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
CPK (n = 435, 430)	22 5%	20 4.5%
Lipase (n = 435, 430)	6 1.4%	6 1.4%

10. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48
Description	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.
Time Frame	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
ALT (n= 435, 431)	8 1.8%	6 1.4%
AST (n = 435, 430)	9 2%	2 0.5%
Albumin (n = 435, 431)	0 0%	0 0%
Alkaline Phosphatase (n= 435, 430)	1 0.2%	1 0.2%
Direct Bilirubin (n = 435, 430)	37 8.4%	4 0.9%
Total Bilirubin (n = 435, 431)	146 33.2%	1 0.2%

11. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
BUN (n = 435, 431)	0 0%	0 0%
Creatinine (n = 435, 431)	1 0.2%	1 0.2%
Phosphorus (n = 435, 431)	0 0%	1 0.2%
Uric acid (n = 435, 431)	0 0%	3 0.7%

12. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48
Description	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.
Time Frame	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Hypercarbia (n = 435, 431)	0 0%	0 0%
Hypocarbia (n = 435, 431)	1 0.2%	7 1.6%
Hypercalcemia (n = 435, 431)	0 0%	0 0%
Hypocalcemia (n = 435, 431)	1 0.2%	4 0.9%
Hyperchloremia (n = 435, 431)	0 0%	0 0%
Hypochloremia (n = 435, 431)	0 0%	0 0%
Hyperkalemia (n = 435, 430)	0 0%	1 0.2%
Hypokalemia (n = 435, 430)	0 0%	1 0.2%
Hypernatremia (n = 435, 431)	0 0%	0 0%
Hyponatremia (n = 435, 431)	0 0%	1 0.2%

13. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48
Description	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.
Time Frame	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Glycosuria (n = 434, 431)	4 0.9%	3 0.7%
Proteinuria (n = 434, 431)	3 0.7%	1 0.2%

14. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48
Description	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.
Time Frame	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Total Cholesterol (n = 434, 428)	30 6.8%	77 17.4%
Triglycerides (n = 434, 428)	2 0.5%	15 3.4%

15. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48
Description	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.
Time Frame	At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Hyperglycemia (n = 434, 428)	1 0.2%	1 0.2%
Hypoglycemia (n = 434, 428)	0 0%	0 0%

16. Secondary Outcome

Title	Mean Change in Weight From Baseline at Week 48
Description	Mean change in body weight from baseline was determined.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population, who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	395	370
Mean (Standard Error) [kg]	4.0 (0.3)	2.0 (0.3)

17. Secondary Outcome

Title	Mean Change in Body Mass Index (BMI) in Participants at Week 48
Description	Mean change in BMI from baseline at Week 48 was determined.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population, who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	393	370
Mean (Standard Error) [kg/m^2]	1.3 (0.10)	0.8 (0.10)

18. Secondary Outcome

Title	Mean Change in Fasting Lipid at Week 48
Description	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.
Time Frame	Baseline (Day 1) and Week 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Fasting total Cholesterol (n=373, 337)	19 (1.6)	38 (1.8)
Fasting HDL Cholesterol (n=371, 335)	9 (0.6)	12 (0.6)
Fasting Non-HDL Cholesterol (n=371, 335)	10 (1.5)	26 (1.7)
Fasting LDL Cholesterol (n=372, 335)	12 (1.4)	18 (1.5)
Fasting Triglycerides (n=373, 337)	20 (4.0)	70 (5.7)

19. Secondary Outcome

Title	Mean Change in Fasting Glucose at Week 48
Description	Mean change from baseline in fasting glucose at Week 48.
Time Frame	Baseline (Day 1) and Week 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population with values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	383	363
Mean (Standard Error) [mg/dL]	2 (0.6)	0 (1.3)

20. Secondary Outcome

Title	Mean Change in Fasting Insulin at Week 48
Description	Mean change from baseline in fasting insulin at Week 48.
Time Frame	Baseline (Day 1) and Week 48.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population with values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	371	352
Mean (Standard Error) [micro units (µU)/mL]	2.5 (0.52)	0.2 (0.38)

21. Secondary Outcome

Title	Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24
Description	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.
Time Frame	Baseline (Day 1) and Week 24.

Outcome Measure Data

Analysis Population Description

As-treated participants with evaluable baseline MOS-HIV . The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	347	351
Physical Health Summary (317, 314)	4.1 (0.46)	3.3 (0.46)
Mental Health Summary (317, 314)	5.3 (0.50)	4.8 (0.52)
Overall Health Perception Subscale (325, 320)	15.2 (1.31)	13.0 (1.41)
Physical Function Subscale (324, 325)	7.6 (1.25)	5.0 (1.30)
Role Function Subscale (325, 325)	10.6 (1.72)	6.5 (1.61)
Social Function Subscale (327, 322)	8.5 (1.54)	7.1 (1.49)
Cognitive Function Subscale (326, 324)	5.6 (1.11)	3.0 (0.94)
Pain Subscale (327, 325)	7.4 (1.37)	8.6 (1.23)
Mental Health Subscale (325, 326)	6.4 (1.09)	7.4 (1.08)
Energy/Fatigue Subscale (323, 326)	7.1 (1.16)	7.5 (1.14)
Health Distress Subscale (323, 326)	14.4 (1.29)	13.9 (1.30)
Quality of Life Subscale (327, 326)	9.9 (1.32)	7.1 (1.29)
Health Transition Subscale (327, 326)	13.1 (1.64)	10.7 (1.55)

22. Secondary Outcome

Title	Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48
Description	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.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

Participants analyzed are as-treated participants with evaluable baseline MOS-HIV. The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	347	351
Physical Health Summary (296, 287)	3.8 (0.50)	3.3 (0.49)
Mental Health Summary (296, 287)	6.0 (0.54)	5.6 (0.54)
Overall Health Perception Subscale (305, 297)	15.6 (1.53)	13.7 (1.51)
Physical Function Subscale (303, 298)	5.8 (1.28)	5.3 (1.24)
Role Function Subscale (307, 298)	8.5 (1.75)	8.1 (1.75)
Social Function Subscale (308, 295)	9.2 (1.48)	7.4 (1.66)
Cognitive Function Subscale (307, 300)	4.8 (1.25)	5.6 (1.05)
Pain Subscale (308, 297)	8.3 (1.39)	8.0 (1.39)
Mental Health Subscale (306, 300)	8.3 (1.21)	8.7 (1.10)
Energy/Fatigue Subscale (304, 300)	8.4 (1.25)	7.9 (1.21)
Health Distress Subscale (304, 300)	14.3 (1.39)	15.0 (1.36)
Quality of Life Subscale (308, 300)	12.9 (1.39)	8.4 (1.34)
Health Transition Subscale (308, 300)	11.0 (1.63)	8.8 (1.64)

23. Secondary Outcome

Title	Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)
Description	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.
Time Frame	IBS-QoL is administered at baseline (Day 1) and Week 4.

Outcome Measure Data

Analysis Population Description

As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	343	349
Overall (306, 316)	3.2 (0.71)	-0.7 (0.66)
Dysphoria (317, 325)	3.3 (0.79)	-0.1 (0.75)
Interference with activity (319, 327)	3.1 (0.86)	-1.9 (0.79)
Body image (321, 329)	1.6 (0.71)	-1.3 (0.68)
Health worry (319, 330)	6.0 (0.96)	2.0 (0.99)
Food avoidance (319, 329)	4.0 (1.03)	-1.7 (1.07)
Social reaction (316, 327)	1.9 (0.76)	-0.8 (0.71)
Sexual (320, 329)	3.7 (1.06)	-0.1 (1.02)
Relationships (321, 328)	1.2 (0.72)	-0.6 (0.75)

24. Secondary Outcome

Title	Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)
Description	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.
Time Frame	IBS-QoL is administered at baseline (Day 1) and Week 12.

Outcome Measure Data

Analysis Population Description

As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	343	349
Overall (301. 310)	4.6 (0.69)	0.2 (0.89)
Dysphoria (308, 319)	4.7 (0.79)	1.2 (0.94)
Interference with activity (310, 320)	5.1 (0.83)	-0.4 (0.96)
Body image (316, 321)	2.1 (0.69)	-0.1 (0.85)
Health worry (312, 320)	7.9 (1.02)	3.6 (1.23)
Food avoidance (316, 322)	5.6 (0.95)	-0.6 (1.25)
Social reaction (311, 316)	3.3 (0.73)	-0.4 (0.95)
Sexual (317, 321)	4.7 (1.11)	-0.4 (1.19)
Relationships (313, 320)	3.5 (0.75)	0.0 (0.99)

25. Secondary Outcome

Title	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)
Description	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.
Time Frame	Baseline (Day 1) and Week 24

Outcome Measure Data

Analysis Population Description

As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	343	349
Overall (290, 289)	4.3 (0.77)	1.4 (0.88)
Dysphoria (295, 298)	4.4 (0.84)	1.8 (0.97)
Interference with activity (294, 297)	4.4 (0.92)	0.0 (1.04)
Body image (299, 300)	1.8 (0.80)	1.1 (0.84)
Health worry (297, 300)	7.5 (0.99)	5.3 (1.18)
Food avoidance (299, 300)	5.6 (1.14)	0.4 (1.29)
Social reaction (295, 297)	3.2 (0.80)	0.4 (0.92)
Sexual (299, 299)	4.3 (1.20)	0.8 (1.15)
Relationships (297, 297)	3.3 (0.89)	1.2 (1.00)

26. Secondary Outcome

Title	Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48
Description	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.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	401	378
Number [Participants]	330 75%	316 71.3%

27. Secondary Outcome

Title	Number of Participants With HIV RNA < 50 c/mL) at Week 96
Description	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.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	440	443
Number [Participants]	327 74.3%	302 68.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference Estimate
	Estimated Value	6.1
	Confidence Interval	(2-Sided) 95%; 0.3 to 12.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

28. Secondary Outcome

Title	Number of Participants With HIV RNA < 400 c/mL) at Week 96
Description	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.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	440	443
Number [Participants]	350 79.5%	330 74.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference Estimate
	Estimated Value	5.1
	Confidence Interval	(2-Sided) 95%; -0.4 to 10.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

29. Secondary Outcome

Title	Reduction of log10 HIV RNA Levels From Baseline at Week 96
Description	Changes from baseline in log10 HIV RNA levels were calculated.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter. log10 HIV RNA changes from baseline were summarized at Week 96 using observed values.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	360	340
Mean (Standard Error) [c/mL]	-3.21 (0.034)	-3.19 (0.036)

30. Secondary Outcome

Title	Mean Change From Baseline in CD4 Cell Count at Week 96
Description	Mean change from baseline in CD4 count among treated participants was determined.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	336	317
Mean (Standard Error) [cells/mm^3]	268 (7.6)	290 (8.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference Estimate
	Estimated Value	-21.2
	Confidence Interval	(2-Sided) 95%; -43.3 to 0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

31. Secondary Outcome

Title	Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96
Description	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.
Time Frame	From Day 1 through Week 96

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Deaths	6 1.4%	6 1.4%
Serious Adverse Events (SAEs)	63 14.3%	50 11.3%
Adverse Events (AEs) leading to discontinuation	13 3%	22 5%

32. Secondary Outcome

Title	Mean Changes in Fasting Lipids at Week 96
Description	Mean change from baseline in fasting lipids at Week 96 was determined.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Fasting total Cholesterol (n=342, 291)	20 (1.8)	37 (1.8)
Fasting HDL Cholesterol (n=341, 291)	7.0 (0.6)	10.0 (0.7)
Fasting Non-HDL Cholesterol (n=341, 291)	13.0 (1.6)	27.0 (1.7)
Fasting LDL Cholesterol (n=342, 291)	12.0 (1.5)	17.0 (1.5)
Fasting Triglycerides (n=342, 291)	16.0 (4.4)	63.0 (5.4)

33. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4
Description	Cmax was derived from plasma concentration versus time data.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive pharmacokinetic (PK) study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	18	21
Geometric Mean (Full Range) [nanogram(ng)/mL]	2897	10654

34. Secondary Outcome

Title	Mean Changes in Fasting Glucose at Week 96
Description	Mean change from baseline in fasting glucose at Week 96 was determined.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population with values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	355	330
Mean (Standard Error) [mg/dL]	4.0 (1.2)	1.0 (1.4)

35. Secondary Outcome

Title	Mean Changes in Fasting Insulin at Week 96
Description	Mean change from baseline in fasting insulin at Week 96.
Time Frame	Baseline (Day 1) and Week 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population with values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	349	324
Mean (Standard Error) [µU/mL]	0.1 (0.47)	-0.8 (0.43)

36. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Hematocrit (n= 434, 431)	0 0%	6 1.4%
Hemoglobin (n= 434, 431)	3 0.7%	7 1.6%
INR (n= 435, 431)	7 1.6%	18 4.1%
Neutrophils (n = 434, 431)	21 4.8%	7 1.6%
Platelets ( n= 433, 431)	5 1.1%	1 0.2%
Prothrombin time (n = 435, 431)	9 2%	24 5.4%
WBC (n = 434, 431)	0 0%	1 0.2%

37. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
CPK (n=435, 430)	34 7.7%	28 6.3%
Lipase (n=435, 430)	9 2%	9 2%

38. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
ALT (n= 435, 431)	11 2.5%	7 1.6%
AST (n = 435, 430)	11 2.5%	5 1.1%
Albumin (n = 435, 431)	0 0%	0 0%
Alkaline Phosphatase (n= 435, 430)	1 0.2%	1 0.2%
Total Bilirubin (n = 435, 431)	192 43.6%	3 0.7%

39. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
BUN (n = 435,431)	0 0%	0 0%
Creatine (n = 435, 431)	1 0.2%	2 0.5%
Phosphorous (n = 435, 431)	0 0%	1 0.2%
Uric acid (n = 435, 431)	1 0.2%	4 0.9%

40. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Hypercarbia (n = 435, 431)	0 0%	0 0%
Hypocarbia (n = 435, 431)	4 0.9%	8 1.8%
Hypercalcemia (n = 435, 431)	0 0%	0 0%
Hypocalcemia (n = 435, 431)	1 0.2%	4 0.9%
Hyperchloremia (n = 435, 431)	0 0%	0 0%
Hypochloremia (n = 435, 431)	0 0%	2 0.5%
Hyperkalemia (n = 435, 430)	0 0%	1 0.2%
Hypokalemia (n = 435, 430)	0 0%	1 0.2%
Hypernatremia (n = 435, 431)	1 0.2%	2 0.5%
Hyponatremia (n = 435, 431)	0 0%	2 0.5%

41. Primary Outcome

Title	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
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	18	21
Geometric Mean (Full Range) [ng*h/mL]	28605	90945

42. Primary Outcome

Title	Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Description	Cmin was derived from the plasma concentration versus time data.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	18	21
Geometric Mean (Full Range) [ng/mL]	526.4	5944

43. Primary Outcome

Title	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
Description	Tmax was derived from the plasma concentration versus time data.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	18	21
Median (Full Range) [Hr]	3.00	4.00

44. Primary Outcome

Title	Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Description	T-half was derived from the plasma concentration versus time data.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	17	12
Mean (Standard Deviation) [Hr]	10.31 (3.32)	13.89 (14.48)

45. Primary Outcome

Title	Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4
Description	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).
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	17	19
Geometric Mean (Full Range) [ng/mL]	19.01	162.7

46. Primary Outcome

Title	Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	17	19
Geometric Mean (Full Range) [ng/mL]	27.33	35.91

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	point estimate
	Estimated Value	0.761
	Confidence Interval	(2-Sided) 90%; 0.507 to 1.142
	Parameter Dispersion	Type: Value:
	Estimation Comments	Point estimates and 90% confidence intervals (CIs) for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.

47. Primary Outcome

Title	Cmax of RTV at Week 4
Description	Cmax was derived from plasma concentration versus time data.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	18	21
Geometric Mean (Full Range) [ng/mL]	959.8	657.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	point estimate
	Estimated Value	1.460
	Confidence Interval	(2-Sided) 90%; 1.005 to 2.121
	Parameter Dispersion	Type: Value:
	Estimation Comments	Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.

48. Primary Outcome

Title	AUC (0-24) of RTV at Week 4
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	18	21
Geometric Mean (Full Range) [ng*h/mL]	6724	8011

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	point estimate
	Estimated Value	0.839
	Confidence Interval	(2-Sided) 90%; 0.612 to 1.151
	Parameter Dispersion	Type: Value:
	Estimation Comments	Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.

49. Primary Outcome

Title	Cmin of RTV at Week 4
Description	Cmin was derived from plasma concentration versus time data.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	18	21
Geometric Mean (Full Range) [ng/mL]	50.52	179.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	point estimate
	Estimated Value	0.282
	Confidence Interval	(2-Sided) 90%; 0.181 to 0.439
	Parameter Dispersion	Type: Value:
	Estimation Comments	Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.

50. Primary Outcome

Title	Cmax of Tenofovir at Week 4
Description	Cmax was derived from plasma concentration versus time data.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	17	20
Geometric Mean (Full Range) [ng/mL]	352.0	380.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	point estimate
	Estimated Value	0.925
	Confidence Interval	(2-Sided) 90%; 0.699 to 1.223
	Parameter Dispersion	Type: Value:
	Estimation Comments	Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.

51. Primary Outcome

Title	Cmin of Tenofovir at Week 4
Description	Cmin was derived from plasma concentration versus time data.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	17	20
Geometric Mean (Full Range) [ng/mL]	72.46	84.98

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	point estimate
	Estimated Value	0.853
	Confidence Interval	(2-Sided) 90%; 0.626 to 1.161
	Parameter Dispersion	Type: Value:
	Estimation Comments	Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.

52. Primary Outcome

Title	AUC (TAU) of Tenofovir at Week 4
Description	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.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

All participants who completed the intensive PK study.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	17	20
Geometric Mean (Full Range) [ng*h/mL]	3272	3675

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	point estimate
	Estimated Value	0.890
	Confidence Interval	(2-Sided) 90%; 0.689 to 1.151
	Parameter Dispersion	Type: Value:
	Estimation Comments	Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.

53. Primary Outcome

Title	Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96
Description	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.
Time Frame	Baseline (Day 1) and Week 96.

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	106	70
Mean (Standard Error) [Ratio]	0.05 (0.015)	0.00 (0.015)

54. Primary Outcome

Title	Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis
Description	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].
Time Frame	Baseline visit

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. The Hardy-Weinberg Equilibrium test was used to check for the genotype quality. All SNPs passed the quality check.

Arm/Group Title	All Participants With Pharmacogenetic Blood Samples
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
Measure Participants	199
RETN_097 WT	164 37.3%
RETN_097 MAC	35 8%
APOE_R176C WT	182 41.4%
APOE_R176C MAC	16 3.6%
CCDC122_5980 WT	126 28.6%
CCDC122_5980 MAC	71 16.1%
IL6_5309 WT	57 13%
IL6_5309 MAC	141 32%
RS11030679 WT	112 25.5%
RS11030679 MAC	87 19.8%
APOE_C130R WT	169 38.4%
APOE_C130R MAC	30 6.8%
RETN_2265 WT	146 33.2%
RETN_2265 MAC	53 12%
RETN_598 WT	119 27%
RETN_598 MAC	80 18.2%
RETN_734 WT	175 39.8%
RETN_734 MAC	22 5%
BRUNOL_1842 WT	121 27.5%
BRUNOL_1842 MAC	77 17.5%
RETN_730 WT	99 22.5%
RETN_730 MAC	100 22.7%

55. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Total Cholesterol (n = 434, 428)	47 10.7%	108 24.4%
Triglycerides (n = 434, 428)	3 0.7%	18 4.1%

56. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Hyperglycemia (n = 434, 428)	3 0.7%	2 0.5%
Hypoglycemia (n = 434, 428)	1 0.2%	0 0%

57. Secondary Outcome

Title	Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96
Description	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.
Time Frame	At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	441	437
Glycosuria (n = 434, 431)	6 1.4%	5 1.1%
Proteinuria (n = 434, 431)	5 1.1%	6 1.4%

58. Secondary Outcome

Title	Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96
Description	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
Time Frame	Baseline (Day 1) and Week 96.

Outcome Measure Data

Analysis Population Description

Resistance analysis are based on randomized population. 2 subjects with baseline phenotypic resistance to ATV/RTV are excluded. Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. "n" signifies the number of participants evaluable for each parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	438	443
Virologic Failure, Week 96 (HIV RNA >= 400 c/mL)	28 6.4%	29 6.5%
Paired Genotypes (n = 28, 29)	26 5.9%	26 5.9%
Paired Phenotypes (n= 28, 29)	25 5.7%	23 5.2%
IAS-USA major PI substitutions (n = 26, 26)	1 0.2%	0 0%
IAS-USA minor PI substitutions (n = 26, 26)	1 0.2%	1 0.2%
PI polymorphisms without IAS-USA (n=26, 26)	11 2.5%	14 3.2%
PI phenotypic resistance (ATV/RTV FC >5.2 (25, 23)	1 0.2%	0 0%
PI phenotypic resistance (LPV/RTV FC>9 (25,23)	0 0%	1 0.2%
PI phenotypic resistance (Other PIs [25, 23])	3 0.7%	6 1.4%
NRTI substitutions (TAMS [26, 26])	1 0.2%	3 0.7%
NRTI substitutions (M184I/V [26, 26])	5 1.1%	7 1.6%
RTI phenotypic resistance (FC [n = 25, 23])	5 1.1%	5 1.1%
RTI phenotypic resistance (TDF [n = 25, 23])	0 0%	2 0.5%
RTI phenotypic resistance (Other NRTI [n =25, 23])	5 1.1%	6 1.4%

59. Secondary Outcome

Title	Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48
Description	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.
Time Frame	DEXA scans were taken at Baseline (Day 1) and at Weeks 48.

Outcome Measure Data

Analysis Population Description

As-treated participants (with values for this parameter)in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	118	81
Mean (Standard Error) [Ratio]	0.04 (0.013)	-0.02 (0.014)

60. Secondary Outcome

Title	Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48
Description	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.
Time Frame	DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	118	82
Trunk Fat	26	16
Limb Fat	22	17
Total Body Fat	23	15

61. Secondary Outcome

Title	Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96
Description	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.
Time Frame	Baseline (Day 1) and Week 96.

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	106	71
Trunk Fat	34	16
Limb Fat	27	15
Total Body Fat	29	15

62. Secondary Outcome

Title	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
Time Frame	Baseline (Day 1) and Week 96.

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	125	99
VAT-to-TAT Ratio (n = 95,68)	-0.04	-0.02
VAT-to-SAT Ratio (n = 95, 68)	-0.22	-0.09
Trunk-to-Limb Fat Ratio (n = 106, 71)	0.05	0.00

63. Secondary Outcome

Title	Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48
Description	Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.
Time Frame	DEXA scans were taken at Baseline (Day 1) and Week 48.

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	118	82
Bone Mineral Density of Both Arms	-1	-1
Bone Mineral Density of Both Legs	-2	-2
Bone Mineral Density of Trunk	-4	-4
Bone Mineral Density of Total Body	-2	-3

64. Secondary Outcome

Title	Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96
Description	Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	106	70
Bone Mineral Density of Both Arms	-1	-2
Bone Mineral Density of Both Legs	-2	-3
Bone Mineral Density of Trunk	-3	-5
Bone Mineral Density of Total Body	-3	-4

65. Secondary Outcome

Title	Mean Change From Baseline in Body Weight at Week 96
Description	Mean change from baseline in weight at Week 96
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population with values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	361	338
Mean (Standard Error) [kg]	5 (0.4)	3 (0.3)

66. Secondary Outcome

Title	Mean Change From Baseline in Body Weight at Week 48
Description	Mean change from baseline in body weight at Week 48 was determined.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	118	85
Mean (Standard Error) [kg]	4 (0.5)	3 (0.7)

67. Secondary Outcome

Title	Mean Change From Baseline in BMI at Week 96
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

Safety analyses of the treatment period are based on treated population with values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	359	338
Mean (Standard Error) [kg/m^2]	1.6 (0.13)	1.0 (0.11)

68. Secondary Outcome

Title	Mean Change From Baseline in Waist Circumference at Week 96
Description	Mean change From baseline in waist circumference at Week 96 was determined.
Time Frame	Baseline (Day 1) and Week 96.

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	100	71
Mean (Standard Error) [cm]	6 (0.8)	2 (0.8)

69. Secondary Outcome

Title	Mean Change From Baseline in Waist Circumference at Week 48
Description	Mean change from baseline in waist circumference at Week 48 was determined.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	109	77
Mean (Standard Error) [cm]	4 (0.6)	2 (0.7)

70. Secondary Outcome

Title	Mean Change From Baseline in Waist-to-hip-ratio at Week 96
Description	Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	71
Mean (Standard Error) [ratio]	0.02 (0.006)	0.01 (0.08)

71. Secondary Outcome

Title	Mean Change From Baseline in BMI at Week 48
Description	Mean change from baseline in BMI at Week 48 was determined.
Time Frame	Baseline (Day 1) and Week 48.

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	118	85
Mean (Standard Error) [kg/m^2]	1.5 (0.19)	1.1 (0.23)

72. Secondary Outcome

Title	Mean Change From Baseline in Waist-to-hip-ratio at Week 48
Description	Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.
Time Frame	Baseline (Day 1) and Week 48

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	108	77
Mean (Standard Error) [ratio]	0.02 (0.008)	0.01 (0.008)

73. Secondary Outcome

Title	Percentage of Participants With Lipoatrophy at Week 96
Description	Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	106	70
Number [percentage of participants]	5 1.1%	7 1.6%

74. Secondary Outcome

Title	Mean Changes From Baseline in Body Weight at Week 96
Description	Mean change in body weight from baseline was determined.
Time Frame	Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	110	78
Mean (Standard Error) [kg]	6 (0.7)	3 (0.8)

75. Secondary Outcome

Title	Mean Change From Baseline in BMI at Week 96
Description	Mean change From baseline in BMI at Week 96 was determined.
Time Frame	Baseline (Day 1) and Week 96

Outcome Measure Data

Analysis Population Description

As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and with values for this parameter.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	110	78
Mean (Standard Error) [kg/m^2]	2.0 (0.26)	1.2 (0.28)

76. Primary Outcome

Title	Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting Non-HDL Cholesterol: RETN_097 WT	12.50 (2.82)	26.98 (2.96)
Fasting Non-HDL Cholesterol: RETN_097 MAC	13.23 (5.56)	52.28 (6.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in fasting non-HDL cholesterol (phenotype) and the RETN_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0847
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

77. Primary Outcome

Title	Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting Triglycerides: RETN_097 WT	21.41 (8.6)	68.06 (9.01)
Fasting Triglycerides: RETN_097 MAC	27.21 (16.9)	157.87 (20.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0058
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

78. Primary Outcome

Title	Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting Triglycerides: RETN_2265 WT	19.61 (9.17)	65.83 (9.36)
Fasting Triglycerides: RETN_2265 MAC	28.70 (14.5)	148.95 (18.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_2265 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_2265 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0058
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

79. Primary Outcome

Title	Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting Triglycerides: RETN_598 WT	20.23 (10.2)	61.66 (10.5)
Fasting Triglycerides: RETN_598 MAC	25.78 (12.2)	123.28 (14.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_598 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_598 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0253
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

80. Primary Outcome

Title	Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting Triglycerides: APOE_C130R WT	23.27 (8.33)	70.71 (9.52)
Fasting Triglycerides: APOE_C130R MAC	13.92 (26.0)	131.56 (19.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the APOE_C130R genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE_C130R reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1173
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

81. Primary Outcome

Title	Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting Triglycerides: RETN_734 WT	23.35 (8.67)	75.12 (8.94)
Fasting Triglycerides: RETN_734 MAC	21.16 (20.4)	155.28 (27.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_734 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_734 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1173
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

82. Primary Outcome

Title	Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting PAI-1: APOE_R176C WT	5.98 (8.85)	7.30 (9.90)
Fasting PAI-1: APOE_R176C WT	-117.27 (37.3)	-5.94 (38.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in fasting PAI-1 (phenotype) and the APOE_R176C genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE_R176C reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1847
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

83. Primary Outcome

Title	Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting TNF-alpha: IL6_5309 WT	-1.19 (2.24)	-2.68 (2.68)
Fasting TNF-alpha: IL6_5309 MAC	6.01 (1.47)	1.41 (1.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis:There is no association between the mean change from baseline in fasting Tumor Necrosis Factor(TNF)-alpha (phenotype) and the IL6_5309 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, wk48 and 96) to test the overall genotype effect (ie. an omnibus test on both marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with IL6_5309 reported in Outcome Measure 16
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1833
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

84. Primary Outcome

Title	Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
Description	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.
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
Fasting TNF-alpha: RS11030679 WT	7.58 (1.72)	-0.13 (1.73)
Fasting TNF-alpha: RS11030679 MAC	0.02 (1.72)	1.27 (2.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in fasting TNF-alpha (phenotype) and the RS11030679 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1833
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

85. Primary Outcome

Title	Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
Description	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).
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
SAT-to-TAT Ratio: CCDC122_5980 WT	0.03 (0.01)	0.03 (0.02)
SAT-to-TAT Ratio: CCDC122_5980 MAC	0.11 (0.02)	0.02 (0.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122_5980 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1694
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

86. Primary Outcome

Title	Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
Description	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).
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
VAT: BRUNOL_1842 WT	23.45 (6.55)	10.38 (7.13)
VAT: BRUNOL_1842 MAC	-3.20 (6.18)	-1.76 (9.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the BRUNOL_1842 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with BRUNOL_1842 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1335
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

87. Primary Outcome

Title	Mean Change From Baseline in VAT Associated With RETN_730
Description	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).
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
VAT: RETN_730 WT	-2.95 (6.10)	13.69 (8.03)
VAT: RETN_730 MAC	23.29 (6.52)	-1.05 (7.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the RETN_730 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_730 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1335
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

88. Primary Outcome

Title	Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
Description	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).
Time Frame	Baseline (Day 1), Week 48, and Week 96.

Outcome Measure Data

Analysis Population Description

Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Arm/Group Title	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.	Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Measure Participants	99	100
VAT-to-TAT Ratio: CCDA122_5980 WT	-0.03 (0.01)	-0.03 (0.02)
VAT-to-TAT Ratio: CCDA122_5980 MAC	-0.11 (0.02)	-0.02 (0.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD, LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD
	Comments	Null Hypothesis: There is no association between the mean change from baseline in VAT-to-TAT Ratio (phenotype) and the CCDA122_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDA122_5980 reported in Outcome Measure 16.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1696
	Comments	The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.
	Method	linear mixed effect model
	Comments	The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)

Adverse Events

Adverse Event Reporting Description	Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Arm/Group Title	ATV/RTV/Tenofovir/Emtricitabine		LPV/RTV/Tenofovir/Emtricitabine
Arm/Group Description	Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.		Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
All Cause Mortality
	ATV/RTV/Tenofovir/Emtricitabine		LPV/RTV/Tenofovir/Emtricitabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ATV/RTV/Tenofovir/Emtricitabine		LPV/RTV/Tenofovir/Emtricitabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/441 (13.8%)		48/437 (11%)
Blood and lymphatic system disorders
ANAEMIA	0/441 (0%)		1/437 (0.2%)
LYMPH NODE PAIN	0/441 (0%)		1/437 (0.2%)
THROMBOCYTOPENIA	2/441 (0.5%)		0/437 (0%)
FEBRILE NEUTROPENIA	0/441 (0%)		1/437 (0.2%)
Cardiac disorders
CARDIAC ARREST	1/441 (0.2%)		1/437 (0.2%)
Congenital, familial and genetic disorders
FANCONI SYNDROME	1/441 (0.2%)		0/437 (0%)
Gastrointestinal disorders
NAUSEA	0/441 (0%)		1/437 (0.2%)
ASCITES	1/441 (0.2%)		0/437 (0%)
COLITIS	0/441 (0%)		1/437 (0.2%)
VOMITING	1/441 (0.2%)		2/437 (0.5%)
DIARRHOEA	3/441 (0.7%)		6/437 (1.4%)
ENTERITIS	1/441 (0.2%)		0/437 (0%)
HAEMORRHOIDS	0/441 (0%)		1/437 (0.2%)
COLONIC STENOSIS	1/441 (0.2%)		0/437 (0%)
PANCREATITIS ACUTE	0/441 (0%)		1/437 (0.2%)
MESENTERIC ARTERY THROMBOSIS	0/441 (0%)		1/437 (0.2%)
General disorders
OEDEMA	0/441 (0%)		1/437 (0.2%)
PYREXIA	1/441 (0.2%)		3/437 (0.7%)
ASTHENIA	1/441 (0.2%)		0/437 (0%)
CHEST PAIN	0/441 (0%)		1/437 (0.2%)
MULTI-ORGAN FAILURE	1/441 (0.2%)		1/437 (0.2%)
Hepatobiliary disorders
CHOLANGITIS	1/441 (0.2%)		0/437 (0%)
CHOLESTASIS	1/441 (0.2%)		0/437 (0%)
CHOLECYSTITIS	2/441 (0.5%)		1/437 (0.2%)
CHOLELITHIASIS	1/441 (0.2%)		0/437 (0%)
CHOLECYSTITIS ACUTE	1/441 (0.2%)		0/437 (0%)
HEPATORENAL SYNDROME	1/441 (0.2%)		0/437 (0%)
Immune system disorders
HYPERSENSITIVITY	1/441 (0.2%)		0/437 (0%)
IMMUNE RECONSTITUTION SYNDROME	0/441 (0%)		1/437 (0.2%)
Infections and infestations
INFECTION	0/441 (0%)		1/437 (0.2%)
PNEUMONIA	2/441 (0.5%)		3/437 (0.7%)
SINUSITIS	0/441 (0%)		1/437 (0.2%)
CELLULITIS	1/441 (0.2%)		0/437 (0%)
ERYSIPELAS	0/441 (0%)		1/437 (0.2%)
MENINGITIS	1/441 (0.2%)		0/437 (0%)
CANDIDIASIS	1/441 (0.2%)		0/437 (0%)
ORAL HERPES	0/441 (0%)		1/437 (0.2%)
PHARYNGITIS	1/441 (0.2%)		0/437 (0%)
TONSILLITIS	0/441 (0%)		1/437 (0.2%)
ABSCESS LIMB	1/441 (0.2%)		0/437 (0%)
APPENDICITIS	2/441 (0.5%)		0/437 (0%)
TUBERCULOSIS	1/441 (0.2%)		0/437 (0%)
SALMONELLOSIS	0/441 (0%)		1/437 (0.2%)
TOXOPLASMOSIS	1/441 (0.2%)		0/437 (0%)
PYELONEPHRITIS	1/441 (0.2%)		1/437 (0.2%)
LOBAR PNEUMONIA	2/441 (0.5%)		1/437 (0.2%)
BRONCHOPNEUMONIA	1/441 (0.2%)		0/437 (0%)
BULLOUS IMPETIGO	1/441 (0.2%)		0/437 (0%)
PERIANAL ABSCESS	0/441 (0%)		1/437 (0.2%)
PERIRECTAL ABSCESS	1/441 (0.2%)		0/437 (0%)
MENINGITIS BACTERIAL	1/441 (0.2%)		0/437 (0%)
SUBCUTANEOUS ABSCESS	1/441 (0.2%)		0/437 (0%)
CEREBRAL TOXOPLASMOSIS	1/441 (0.2%)		1/437 (0.2%)
PULMONARY TUBERCULOSIS	3/441 (0.7%)		2/437 (0.5%)
MENINGITIS CRYPTOCOCCAL	2/441 (0.5%)		0/437 (0%)
CYTOMEGALOVIRUS INFECTION	0/441 (0%)		1/437 (0.2%)
DISSEMINATED TUBERCULOSIS	0/441 (0%)		1/437 (0.2%)
PARASITIC GASTROENTERITIS	1/441 (0.2%)		0/437 (0%)
EXTRAPULMONARY TUBERCULOSIS	0/441 (0%)		1/437 (0.2%)
PELVIC INFLAMMATORY DISEASE	1/441 (0.2%)		0/437 (0%)
PNEUMOCYSTIS JIROVECI PNEUMONIA	0/441 (0%)		2/437 (0.5%)
UPPER RESPIRATORY TRACT INFECTION	2/441 (0.5%)		0/437 (0%)
MYCOBACTERIUM AVIUM COMPLEX INFECTION	1/441 (0.2%)		2/437 (0.5%)
Injury, poisoning and procedural complications
INJURY	1/441 (0.2%)		0/437 (0%)
HEAD INJURY	1/441 (0.2%)		0/437 (0%)
CHEST INJURY	0/441 (0%)		1/437 (0.2%)
JAW FRACTURE	1/441 (0.2%)		0/437 (0%)
HAND FRACTURE	0/441 (0%)		1/437 (0.2%)
GUN SHOT WOUND	0/441 (0%)		1/437 (0.2%)
TIBIA FRACTURE	1/441 (0.2%)		0/437 (0%)
WRIST FRACTURE	0/441 (0%)		1/437 (0.2%)
ERGOT POISONING	0/441 (0%)		1/437 (0.2%)
JOINT DISLOCATION	0/441 (0%)		1/437 (0.2%)
MULTIPLE INJURIES	0/441 (0%)		1/437 (0.2%)
LOWER LIMB FRACTURE	1/441 (0.2%)		0/437 (0%)
ROAD TRAFFIC ACCIDENT	1/441 (0.2%)		1/437 (0.2%)
Investigations
WEIGHT DECREASED	1/441 (0.2%)		3/437 (0.7%)
HEPATIC ENZYME INCREASED	1/441 (0.2%)		0/437 (0%)
BLOOD CREATINE PHOSPHOKINASE INCREASED	1/441 (0.2%)		1/437 (0.2%)
Metabolism and nutrition disorders
GOUT	0/441 (0%)		1/437 (0.2%)
DEHYDRATION	1/441 (0.2%)		3/437 (0.7%)
MALNUTRITION	0/441 (0%)		1/437 (0.2%)
HYPERLIPIDAEMIA	0/441 (0%)		1/437 (0.2%)
HYPERLACTACIDAEMIA	1/441 (0.2%)		0/437 (0%)
Musculoskeletal and connective tissue disorders
MYALGIA	0/441 (0%)		1/437 (0.2%)
BACK PAIN	2/441 (0.5%)		0/437 (0%)
SACROILIITIS	0/441 (0%)		1/437 (0.2%)
OSTEONECROSIS	0/441 (0%)		1/437 (0.2%)
RHABDOMYOLYSIS	0/441 (0%)		1/437 (0.2%)
LUMBAR SPINAL STENOSIS	0/441 (0%)		1/437 (0.2%)
INTERVERTEBRAL DISC PROTRUSION	0/441 (0%)		1/437 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA	0/441 (0%)		1/437 (0.2%)
MEDULLOBLASTOMA	0/441 (0%)		1/437 (0.2%)
CERVIX CARCINOMA	0/441 (0%)		1/437 (0.2%)
KAPOSI'S SARCOMA	1/441 (0.2%)		2/437 (0.5%)
TESTICULAR NEOPLASM	1/441 (0.2%)		0/437 (0%)
BASAL CELL CARCINOMA	1/441 (0.2%)		0/437 (0%)
RENAL CELL CARCINOMA	0/441 (0%)		1/437 (0.2%)
DIFFUSE LARGE B-CELL LYMPHOMA	1/441 (0.2%)		0/437 (0%)
BENIGN MALE REPRODUCTIVE TRACT NEOPLASM	1/441 (0.2%)		0/437 (0%)
Nervous system disorders
HEADACHE	0/441 (0%)		1/437 (0.2%)
CEREBROVASCULAR ACCIDENT	1/441 (0.2%)		0/437 (0%)
METABOLIC ENCEPHALOPATHY	1/441 (0.2%)		0/437 (0%)
COMPLEX REGIONAL PAIN SYNDROME	0/441 (0%)		1/437 (0.2%)
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS	0/441 (0%)		1/437 (0.2%)
Psychiatric disorders
ANXIETY	1/441 (0.2%)		0/437 (0%)
DEPRESSION	1/441 (0.2%)		0/437 (0%)
SUICIDE ATTEMPT	2/441 (0.5%)		1/437 (0.2%)
BIPOLAR DISORDER	1/441 (0.2%)		0/437 (0%)
SUICIDAL IDEATION	1/441 (0.2%)		0/437 (0%)
Renal and urinary disorders
RENAL FAILURE	1/441 (0.2%)		0/437 (0%)
URINARY RETENTION	0/441 (0%)		1/437 (0.2%)
Reproductive system and breast disorders
ADNEXA UTERI MASS	1/441 (0.2%)		0/437 (0%)
Respiratory, thoracic and mediastinal disorders
EPISTAXIS	0/441 (0%)		1/437 (0.2%)
ACUTE RESPIRATORY FAILURE	1/441 (0.2%)		1/437 (0.2%)
INTERSTITIAL LUNG DISEASE	0/441 (0%)		1/437 (0.2%)
Skin and subcutaneous tissue disorders
DRUG ERUPTION	1/441 (0.2%)		0/437 (0%)
DERMATITIS ALLERGIC	0/441 (0%)		1/437 (0.2%)
Other (Not Including Serious) Adverse Events
	ATV/RTV/Tenofovir/Emtricitabine		LPV/RTV/Tenofovir/Emtricitabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	355/441 (80.5%)		370/437 (84.7%)
Eye disorders
OCULAR ICTERUS	43/441 (9.8%)		0/437 (0%)
Gastrointestinal disorders
NAUSEA	73/441 (16.6%)		103/437 (23.6%)
VOMITING	34/441 (7.7%)		48/437 (11%)
DIARRHOEA	108/441 (24.5%)		236/437 (54%)
DYSPEPSIA	24/441 (5.4%)		27/437 (6.2%)
ABDOMINAL PAIN	30/441 (6.8%)		31/437 (7.1%)
General disorders
PYREXIA	25/441 (5.7%)		28/437 (6.4%)
Hepatobiliary disorders
JAUNDICE	83/441 (18.8%)		2/437 (0.5%)
HYPERBILIRUBINAEMIA	51/441 (11.6%)		3/437 (0.7%)
Infections and infestations
INFLUENZA	33/441 (7.5%)		33/437 (7.6%)
BRONCHITIS	37/441 (8.4%)		29/437 (6.6%)
PHARYNGITIS	17/441 (3.9%)		23/437 (5.3%)
HERPES ZOSTER	19/441 (4.3%)		22/437 (5%)
NASOPHARYNGITIS	66/441 (15%)		73/437 (16.7%)
URINARY TRACT INFECTION	24/441 (5.4%)		22/437 (5%)
UPPER RESPIRATORY TRACT INFECTION	37/441 (8.4%)		54/437 (12.4%)
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA	19/441 (4.3%)		48/437 (11%)
Musculoskeletal and connective tissue disorders
BACK PAIN	38/441 (8.6%)		14/437 (3.2%)
ARTHRALGIA	32/441 (7.3%)		20/437 (4.6%)
Nervous system disorders
HEADACHE	81/441 (18.4%)		67/437 (15.3%)
DIZZINESS	34/441 (7.7%)		29/437 (6.6%)
Respiratory, thoracic and mediastinal disorders
COUGH	28/441 (6.3%)		34/437 (7.8%)
Skin and subcutaneous tissue disorders
RASH	27/441 (6.1%)		19/437 (4.3%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.