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

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

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

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

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

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: All participants who completed the intensive PK study.

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

Population: 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.

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

Population: 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.

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

Population: All participants who completed the intensive PK study.

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.

Population: 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.

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

Time frame: Baseline (Day 1) and Week 48.

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

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

Time frame: Baseline (Day 1) and Week 96

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

Time frame: Baseline (Day 1) and Week 96

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

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

Time frame: Baseline (Day 1) and Week 48

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

Mean change from baseline in weight at Week 96

Time frame: Baseline (Day 1) and Week 96

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

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

Time frame: Baseline (Day 1) and Week 96

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

Mean change from baseline in CD4 cell counts was determined.

Time frame: Baseline (Day 1) and Week 48.

Population: All treated participants with data for this parameter.

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.

Population: 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.

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

Population: 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.

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.

Population: 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.

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

Population: 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.

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.

Population: 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.

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

Time frame: Baseline (Day 1) and Week 48

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

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

Time frame: Baseline (Day 1) and Week 96.

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

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

Time frame: Baseline (Day 1) and Week 48

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

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

Time frame: Baseline (Day 1) and Week 96

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

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

Time frame: Baseline (Day 1) and Week 48

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

Mean change from baseline in fasting glucose at Week 48.

Time frame: Baseline (Day 1) and Week 48.

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

Mean change from baseline in fasting insulin at Week 48.

Time frame: Baseline (Day 1) and Week 48.

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

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.

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

Mean change in body weight from baseline was determined.

Time frame: Baseline (Day 1) and Week 48

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

Mean change in body weight from baseline was determined.

Time frame: Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.

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

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

Time frame: Baseline (Day 1) and Week 96

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

Mean change from baseline in fasting insulin at Week 96.

Time frame: Baseline (Day 1) and Week 96.

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

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.

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

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

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

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.

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

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.

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

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.

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

Time frame: Baseline (Day 1) and Week 96.

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

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

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

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.

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

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

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

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

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

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

Population: 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.

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

Population: 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.

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

Population: 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.

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.

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

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.

Population: 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.

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.

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

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.

Population: 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.

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.

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

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

Population: 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.

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.

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

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.

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

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.

Population: 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.

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.

Population: 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.

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.

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

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.

Population: 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.

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

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

Changes from baseline in log10 HIV RNA levels were calculated.

Time frame: Baseline (Day 1) and Week 96

Population: 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.

Changes from baseline in log10 HIV RNA levels were calculated.

Time frame: Baseline (Day 1) and Week 48

Population: All treated participants with data for this parameter.

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

Population: 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.