BMS-Reyataz Study in Treatment in Naive Subjects to Compa... | NCT00272779

NCT00272779

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atazanavir (ATV) + Ritonovir (RTV)	Active Comparator	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 Drug: RTV Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet
Lopinavir (LPV) + RTV	Active Comparator	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 Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet Drug: LPV

Name	Type	Description	Arm Group Labels	Other Names
ATV	Drug	300mg Oral capsules for 96 weeks	Atazanavir (ATV) + Ritonovir (RTV)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48	HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.	Baseline (Day 1) and Week 48
Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4	Cmax was derived from plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.
Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4	AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4	Cmin was derived from the plasma concentration versus time data.	Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
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

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With HIV RNA < 400 c/mL at Week 48	HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.	Baseline (Day 1) and Week 48
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)

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Phoenix	Arizona		United States
Local Institution

PubMed Identifier	Type	Citation	Retractions
20032785	Background	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.
18722869

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48

HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.

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.

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Number

Participants

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants	OG000440 OG001443

Title

Denominators

Categories

Title	Measurements
	OG000343 OG001338

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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	Cochran-Mantel-Haenszel	The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions > -10%.		Assuming 70% response rate (70% of participants remain on treatment for 48 wks and HIV RNA <50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV	Difference Estimate	1.7			2-Sided	95	-3.8

Secondary

Number of Participants With HIV RNA < 400 c/mL at Week 48

HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.

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.

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Number

Participants

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)

TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.

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

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Number

Participants

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Reduction of log10 HIV RNA Levels From Baseline to Week 48

Changes from baseline in log10 HIV RNA levels were calculated.

All treated participants with data for this parameter.

Posted

Mean

Standard Error

c/mL

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48

Mean change from baseline in CD4 cell counts was determined.

All treated participants with data for this parameter.

Posted

Mean

Standard Error

c/mm^3

Baseline (Day 1) and Week 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48

Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change

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.

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Number

Participants

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48

AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.

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

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Number

Participants

From baseline (Day 1) to Week 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)

Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.

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.

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Number

Participants

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

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Secondary

Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48

Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 - 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.

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.

Posted

Number

Participants

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

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48

Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.

Posted

Number

Participants

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

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48

Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48

Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.

Posted

Number

Participants

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

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48

Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.

Posted

Number

Participants

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

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48

Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.

Posted

Number

Participants

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

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48

Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.

Posted

Number

Participants

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

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Change in Weight From Baseline at Week 48

Mean change in body weight from baseline was determined.

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

Posted

Mean

Standard Error

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change in Body Mass Index (BMI) in Participants at Week 48

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

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

Posted

Mean

Standard Error

kg/m^2

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change in Fasting Lipid at Week 48

Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.

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

Posted

Mean

Standard Error

milligrams/deciliter (mg/dL)

Baseline (Day 1) and Week 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts

Secondary

Mean Change in Fasting Glucose at Week 48

Mean change from baseline in fasting glucose at Week 48.

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

Posted

Mean

Standard Error

mg/dL

Baseline (Day 1) and Week 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change in Fasting Insulin at Week 48

Mean change from baseline in fasting insulin at Week 48.

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

Posted

Mean

Standard Error

micro units (µU)/mL

Baseline (Day 1) and Week 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

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

Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.

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.

Posted

Mean

Standard Error

Units on Scale

Baseline (Day 1) and Week 24.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

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

MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.

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.

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Mean

Standard Error

Units on Scale

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)

The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.

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.

Posted

Mean

Standard Error

Units on Scale

IBS-QoL is administered at baseline (Day 1) and Week 4.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)

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.

Posted

Mean

Standard Error

Units on Scale

IBS-QoL is administered at baseline (Day 1) and Week 12.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)

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.

Posted

Mean

Standard Error

Units on a scale

Baseline (Day 1) and Week 24

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Secondary

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

The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.

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

Posted

Number

Participants

Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With HIV RNA < 50 c/mL) at Week 96

HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.

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.

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Number

Participants

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With HIV RNA < 400 c/mL) at Week 96

HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.

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.

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Number

Participants

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Reduction of log10 HIV RNA Levels From Baseline at Week 96

Changes from baseline in log10 HIV RNA levels were calculated.

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.

Posted

Mean

Standard Error

c/mL

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts

Secondary

Mean Change From Baseline in CD4 Cell Count at Week 96

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

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

Posted

Mean

Standard Error

cells/mm^3

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96

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

Posted

Number

Participants

From Day 1 through Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Changes in Fasting Lipids at Week 96

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

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

Posted

Mean

Standard Error

mg/dL

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Primary

Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4

Cmax was derived from plasma concentration versus time data.

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

Posted

Geometric Mean

Full Range

nanogram(ng)/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Changes in Fasting Glucose at Week 96

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

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

Posted

Mean

Standard Error

mg/dL

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Changes in Fasting Insulin at Week 96

Mean change from baseline in fasting insulin at Week 96.

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

Posted

Mean

Standard Error

µU/mL

Baseline (Day 1) and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96

Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Secondary

Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96

Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 - 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN.

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

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96

Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96

Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL.

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

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96

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

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng*h/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

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

Cmin was derived from the plasma concentration versus time data.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

Tmax was derived from the plasma concentration versus time data.

All participants who completed the intensive PK study.

Posted

Median

Full Range

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4

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

All participants who completed the intensive PK study.

Posted

Mean

Standard Deviation

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

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

EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4

IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Cmax of RTV at Week 4

Cmax was derived from plasma concentration versus time data.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts

Primary

AUC (0-24) of RTV at Week 4

AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng*h/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units

Primary

Cmin of RTV at Week 4

Cmin was derived from plasma concentration versus time data.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts

Primary

Cmax of Tenofovir at Week 4

Cmax was derived from plasma concentration versus time data.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts

Primary

Cmin of Tenofovir at Week 4

Cmin was derived from plasma concentration versus time data.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts

Primary

AUC (TAU) of Tenofovir at Week 4

AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.

All participants who completed the intensive PK study.

Posted

Geometric Mean

Full Range

ng*h/mL

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.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

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

Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.

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

Posted

Mean

Standard Error

Ratio

Baseline (Day 1) and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis

19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous].

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.

Posted

Number

participants

Baseline visit

ID	Title	Description
OG000	All Participants With Pharmacogenetic Blood Samples	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96

Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.

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

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96

Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.

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

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96

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

Posted

Number

Participants

At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96

Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change

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.

Posted

Number

Participants

Baseline (Day 1) and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD

Secondary

Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48

Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.

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.

Posted

Mean

Standard Error

Ratio

DEXA scans were taken at Baseline (Day 1) and at Weeks 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48

The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.

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

Posted

Mean

95% Confidence Interval

Percentage

DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96

The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.

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

Posted

Mean

95% Confidence Interval

Percentage

Baseline (Day 1) and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA

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

Posted

Mean

95% Confidence Interval

Ratio

Baseline (Day 1) and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48

Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.

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

Posted

Mean

95% Confidence Interval

grams/ centimeters ^2 (g/cm^2)

DEXA scans were taken at Baseline (Day 1) and Week 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Secondary

Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96

Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.

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

Posted

Mean

95% Confidence Interval

g/cm^2

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts

Secondary

Mean Change From Baseline in Body Weight at Week 96

Mean change from baseline in weight at Week 96

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

Posted

Mean

Standard Error

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Body Weight at Week 48

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

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

Posted

Mean

Standard Error

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline in BMI at Week 96

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

Posted

Mean

Standard Error

kg/m^2

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Waist Circumference at Week 96

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

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

Posted

Mean

Standard Error

Baseline (Day 1) and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Waist Circumference at Week 48

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

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

Posted

Mean

Standard Error

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Waist-to-hip-ratio at Week 96

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

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

Posted

Mean

Standard Error

ratio

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline in BMI at Week 48

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

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

Posted

Mean

Standard Error

kg/m^2

Baseline (Day 1) and Week 48.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Mean Change From Baseline in Waist-to-hip-ratio at Week 48

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

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

Posted

Mean

Standard Error

ratio

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Secondary

Percentage of Participants With Lipoatrophy at Week 96

Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.

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

Posted

Number

percentage of participants

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units

Secondary

Mean Changes From Baseline in Body Weight at Week 96

Mean change in body weight from baseline was determined.

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

Posted

Mean

Standard Error

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

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts

Secondary

Mean Change From Baseline in BMI at Week 96

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

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

Posted

Mean

Standard Error

kg/m^2

Baseline (Day 1) and Week 96

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Units	Counts
Participants

Primary

Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

mg/dL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

mg/dL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

mg/dL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

mg/dL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

mg/dL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

mg/dL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

ng/dL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

pg/mL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.

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.

Posted

Mean

Standard Error

pg/mL

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).

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.

Posted

Mean

Standard Error

cm^2

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).

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.

Posted

Mean

Standard Error

cm^2

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in VAT Associated With RETN_730

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).

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.

Posted

Mean

Standard Error

cm^2

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Primary

Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980

The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).

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.

Posted

Mean

Standard Error

cm^2

Baseline (Day 1), Week 48, and Week 96.

ID	Title	Description
OG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
OG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
WEIGHT DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0013 affected437 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0011 affected437 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0011 affected437 at risk
ANXIETY	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
DEPRESSION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0011 affected437 at risk
BIPOLAR DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
CHOLESTASIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0011 affected437 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
HEPATORENAL SYNDROME	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
IMMUNE RECONSTITUTION SYNDROME	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
HEADACHE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
COMPLEX REGIONAL PAIN SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
ASCITES	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
COLITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
VOMITING	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0012 affected437 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected441 at risk EG0016 affected437 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
COLONIC STENOSIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
MESENTERIC ARTERY THROMBOSIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0013 affected437 at risk
SINUSITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
ERYSIPELAS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
MENINGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
CANDIDIASIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
ORAL HERPES	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
PHARYNGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
TONSILLITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
APPENDICITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0010 affected437 at risk
TUBERCULOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
SALMONELLOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
TOXOPLASMOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0011 affected437 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0011 affected437 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
BULLOUS IMPETIGO	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
PERIANAL ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
PERIRECTAL ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
MENINGITIS BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
CEREBRAL TOXOPLASMOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0011 affected437 at risk
PULMONARY TUBERCULOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected441 at risk EG0012 affected437 at risk
MENINGITIS CRYPTOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0010 affected437 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
DISSEMINATED TUBERCULOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
PARASITIC GASTROENTERITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
EXTRAPULMONARY TUBERCULOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
PELVIC INFLAMMATORY DISEASE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
PNEUMOCYSTIS JIROVECI PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0012 affected437 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0010 affected437 at risk
MYCOBACTERIUM AVIUM COMPLEX INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0012 affected437 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
GOUT	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0013 affected437 at risk
MALNUTRITION	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
HYPERLACTACIDAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
LYMPH NODE PAIN	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0010 affected437 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
DRUG ERUPTION	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
ADNEXA UTERI MASS	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
FANCONI SYNDROME	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
CHEST INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
JAW FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
GUN SHOT WOUND	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
ERGOT POISONING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
MULTIPLE INJURIES	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0011 affected437 at risk
ABORTION SPONTANEOUS	Pregnancy, puerperium and perinatal conditions	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected441 at risk EG0010 affected437 at risk
SACROILIITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0011 affected437 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
OEDEMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
PYREXIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0013 affected437 at risk
ASTHENIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
CHEST PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0011 affected437 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
MEDULLOBLASTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
CERVIX CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
KAPOSI'S SARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0012 affected437 at risk
TESTICULAR NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected441 at risk EG0011 affected437 at risk
DIFFUSE LARGE B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk
BENIGN MALE REPRODUCTIVE TRACT NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected441 at risk EG0010 affected437 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
OCULAR ICTERUS	Eye disorders	MedDRA 11.0	Systematic Assessment	EG00043 affected441 at risk EG0010 affected437 at risk
JAUNDICE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG00083 affected441 at risk EG0012 affected437 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG00051 affected441 at risk EG0013 affected437 at risk
HEADACHE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00081 affected441 at risk EG00167 affected437 at risk
DIZZINESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00034 affected441 at risk EG00129 affected437 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00073 affected441 at risk EG001103 affected437 at risk
VOMITING	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00034 affected441 at risk EG00148 affected437 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG000108 affected441 at risk EG001236 affected437 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00024 affected441 at risk EG00127 affected437 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00030 affected441 at risk EG00131 affected437 at risk
INFLUENZA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00033 affected441 at risk EG00133 affected437 at risk
BRONCHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00037 affected441 at risk EG00129 affected437 at risk
PHARYNGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00017 affected441 at risk EG00123 affected437 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00019 affected441 at risk EG00122 affected437 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00066 affected441 at risk EG00173 affected437 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00024 affected441 at risk EG00122 affected437 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00037 affected441 at risk EG00154 affected437 at risk
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected441 at risk EG00148 affected437 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00027 affected441 at risk EG00119 affected437 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00038 affected441 at risk EG00114 affected437 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00032 affected441 at risk EG00120 affected437 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00028 affected441 at risk EG00134 affected437 at risk
PYREXIA	General disorders	MedDRA 11.0	Systematic Assessment	EG00025 affected441 at risk EG00128 affected437 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D000069446	Atazanavir Sulfate
D013607	Tablets

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD	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.
BG001	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ATV/RTV/Tenofovir/Emtricitabine	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.			61	441	355	441
EG001	LPV/RTV/Tenofovir/Emtricitabine	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.			48	437	370	437