Trial Outcomes & Findings for BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada (NCT NCT00272779)

NCT ID: NCT00272779

Last Updated: 2011-05-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1057 participants
• Primary outcome timeframe: Baseline (Day 1) and Week 48
• Results posted on: 2011-05-09

Participant Flow

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

Participant milestones

Measure	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.	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.
Baseline Through Week 48 STARTED	440	443
Baseline Through Week 48 RECEIVED ANY TREATMENT	441	437
Baseline Through Week 48 TREATED AS RANDOMIZED	438	440
Baseline Through Week 48 Discontinued Before Week 48	39	58
Baseline Through Week 48 Discontinued on or After Week 48	14	14
Baseline Through Week 48 STILL ON TREATMENT	385	368
Baseline Through Week 48 COMPLETED	0	0
Baseline Through Week 48 NOT COMPLETED	440	443
Baseline Through Week 96 STARTED	440	443
Baseline Through Week 96 RECEIVED ANY TREATMENT	441	437
Baseline Through Week 96 COMPLETED	301	307
Baseline Through Week 96 NOT COMPLETED	139	136

Reasons for withdrawal

Measure	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.	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.
Baseline Through Week 48 Adverse event before Week 48	10	14
Baseline Through Week 48 Death before Week 48	4	4
Baseline Through Week 48 Lack of efficacy before Week 48	5	8
Baseline Through Week 48 Lost to follow-up before Week 48	6	6
Baseline Through Week 48 Viral load rebound before Week 48	1	0
Baseline Through Week 48 Poor/non compliance before Week 48	6	9
Baseline Through Week 48 Pregnancy before Week 48	2	2
Baseline Through Week 48 No longer meets criteria before Week 48	1	0
Baseline Through Week 48 Withdrew consent before Week 48	4	13
Baseline Through Week 48 Participant's decision before wk 48	0	1
Baseline Through Week 48 Chose different site before wk 48	0	1
Baseline Through Week 48 Adverse event on/after Week 48	1	1
Baseline Through Week 48 Death on/after Week 48	1	1
Baseline Through Week 48 Lack of efficacy on/after Week 48	7	1
Baseline Through Week 48 Poor/non compliance on/after Week	2	2
Baseline Through Week 48 No longer meets criteria on/after Wk 48	2	2
Baseline Through Week 48 Pregnancy on/after Week 48	1	2
Baseline Through Week 48 Withdrew consent on/after Week 48	0	2
Baseline Through Week 48 Continuing treatment	385	368
Baseline Through Week 48 Lost to follow-up on/after Week 48	0	3
Baseline Through Week 48 Never treated	2	3
Baseline Through Week 96 Adverse event before Week 96	13	22
Baseline Through Week 96 Death before Week 96	6	5
Baseline Through Week 96 Lack of efficacy before Week 96	16	10
Baseline Through Week 96 Lost to follow up before Week 96	10	13
Baseline Through Week 96 Participant Imprisoned before Week 96	1	0
Baseline Through Week 96 Poor/non compliance before Week 96	12	16
Baseline Through Week 96 Pregnancy before Week 96	5	7
Baseline Through Week 96 No longer meets criteria before Week 96	4	3
Baseline Through Week 96 Withdrew consent before Week 96	5	18
Baseline Through Week 96 Changed address before Week 96	0	1
Baseline Through Week 96 Lost to follow-up at Week 96	1	0
Baseline Through Week 96 Poor/non compliance at Week 96]	2	0
Baseline Through Week 96 Pregnancy at Week 96	1	0
Baseline Through Week 96 Never treated	2	3
Baseline Through Week 96 Continuing on treatment	61	38

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=440 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=443 Participants Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.	Total n=883 Participants Total of all reporting groups
Age Continuous	36 years STANDARD_DEVIATION 9.1 • n=5 Participants	37 years STANDARD_DEVIATION 10.0 • n=7 Participants	36 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	138 Participants n=5 Participants	139 Participants n=7 Participants	277 Participants n=5 Participants
Sex: Female, Male Male	302 Participants n=5 Participants	304 Participants n=7 Participants	606 Participants n=5 Participants
Race/Ethnicity, Customized Asian	42 participants n=5 Participants	41 participants n=7 Participants	83 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	83 participants n=5 Participants	80 participants n=7 Participants	163 participants n=5 Participants
Race/Ethnicity, Customized White	207 participants n=5 Participants	221 participants n=7 Participants	428 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Race/Ethnicity, Customized Mestizo	71 participants n=5 Participants	68 participants n=7 Participants	139 participants n=5 Participants
Race/Ethnicity, Customized Mixed race	30 participants n=5 Participants	27 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=440 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=443 Participants 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.
Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48	343 Participants	338 Participants

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.

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

Cmax was derived from plasma concentration versus time data.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=18 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=21 Participants 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.
Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4	2897 nanogram(ng)/mL Interval 837.0 to 5610.0	10654 nanogram(ng)/mL Interval 5658.0 to 31316.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

AUC(TAU) was derived from 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=18 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=21 Participants 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.
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	28605 ng*h/mL Interval 9908.0 to 58872.0	90945 ng*h/mL Interval 43260.0 to 302989.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

Cmin was derived from the plasma concentration versus time data.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=18 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=21 Participants 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.
Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4	526.4 ng/mL Interval 130.0 to 1350.0	5944 ng/mL Interval 1555.0 to 22739.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

Tmax was derived from the plasma concentration versus time data.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=18 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=21 Participants 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.
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	3.00 Hr Interval 1.5 to 24.0	4.00 Hr Interval 0.0 to 12.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=17 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=12 Participants 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.
Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4	10.31 Hr Standard Deviation 3.32	13.89 Hr Standard Deviation 14.48

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

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).

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=17 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=19 Participants 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.
Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4	19.01 ng/mL Interval 8.29 to 35.23	162.7 ng/mL Interval 100.6 to 471.6

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=17 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=19 Participants 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.
Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4	27.33 ng/mL Interval 3.94 to 77.27	35.91 ng/mL Interval 10.76 to 129.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

Cmax was derived from plasma concentration versus time data.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=18 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=21 Participants 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.
Cmax of RTV at Week 4	959.8 ng/mL Interval 139.0 to 2900.0	657.4 ng/mL Interval 193.8 to 1814.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=18 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=21 Participants 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.
AUC (0-24) of RTV at Week 4	6724 ng*h/mL Interval 1371.0 to 23854.0	8011 ng*h/mL Interval 2815.0 to 19929.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

Cmin was derived from plasma concentration versus time data.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=18 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=21 Participants 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.
Cmin of RTV at Week 4	50.52 ng/mL Interval 14.5 to 298.0	179.0 ng/mL Interval 42.82 to 763.8

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

Cmax was derived from plasma concentration versus time data.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=17 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=20 Participants 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.
Cmax of Tenofovir at Week 4	352.0 ng/mL Interval 104.8 to 641.8	380.7 ng/mL Interval 118.0 to 1801.0

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

Cmin was derived from plasma concentration versus time data.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=17 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=20 Participants 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.
Cmin of Tenofovir at Week 4	72.46 ng/mL Interval 21.08 to 114.7	84.98 ng/mL Interval 44.27 to 757.2

PRIMARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.

Population: All participants who completed the intensive PK study.

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=17 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=20 Participants 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.
AUC (TAU) of Tenofovir at Week 4	3272 ng*h/mL Interval 1678.0 to 5486.0	3675 ng*h/mL Interval 2240.0 to 25385.0

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 96.

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=106 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=70 Participants 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.
Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96	0.05 Ratio Standard Error 0.015	0.00 Ratio Standard Error 0.015

PRIMARY outcome

Timeframe: Baseline visit

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

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].

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=199 Participants 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.	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.
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_097 WT	164 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_097 MAC	35 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis APOE_R176C WT	182 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis APOE_R176C MAC	16 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis CCDC122_5980 WT	126 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis CCDC122_5980 MAC	71 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis IL6_5309 WT	57 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis IL6_5309 MAC	141 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RS11030679 WT	112 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RS11030679 MAC	87 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis APOE_C130R WT	169 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis APOE_C130R MAC	30 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_2265 WT	146 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_2265 MAC	53 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_598 WT	119 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_598 MAC	80 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_734 WT	175 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_734 MAC	22 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis BRUNOL_1842 WT	121 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis BRUNOL_1842 MAC	77 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_730 WT	99 participants	—
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis RETN_730 MAC	100 participants	—

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097 Fasting Non-HDL Cholesterol: RETN_097 WT	12.50 mg/dL Standard Error 2.82	26.98 mg/dL Standard Error 2.96
Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097 Fasting Non-HDL Cholesterol: RETN_097 MAC	13.23 mg/dL Standard Error 5.56	52.28 mg/dL Standard Error 6.67

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097 Fasting Triglycerides: RETN_097 WT	21.41 mg/dL Standard Error 8.6	68.06 mg/dL Standard Error 9.01
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097 Fasting Triglycerides: RETN_097 MAC	27.21 mg/dL Standard Error 16.9	157.87 mg/dL Standard Error 20.4

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265 Fasting Triglycerides: RETN_2265 WT	19.61 mg/dL Standard Error 9.17	65.83 mg/dL Standard Error 9.36
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265 Fasting Triglycerides: RETN_2265 MAC	28.70 mg/dL Standard Error 14.5	148.95 mg/dL Standard Error 18.3

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598 Fasting Triglycerides: RETN_598 WT	20.23 mg/dL Standard Error 10.2	61.66 mg/dL Standard Error 10.5
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598 Fasting Triglycerides: RETN_598 MAC	25.78 mg/dL Standard Error 12.2	123.28 mg/dL Standard Error 14.2

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R Fasting Triglycerides: APOE_C130R WT	23.27 mg/dL Standard Error 8.33	70.71 mg/dL Standard Error 9.52
Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R Fasting Triglycerides: APOE_C130R MAC	13.92 mg/dL Standard Error 26.0	131.56 mg/dL Standard Error 19.3

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734 Fasting Triglycerides: RETN_734 WT	23.35 mg/dL Standard Error 8.67	75.12 mg/dL Standard Error 8.94
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734 Fasting Triglycerides: RETN_734 MAC	21.16 mg/dL Standard Error 20.4	155.28 mg/dL Standard Error 27.0

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C Fasting PAI-1: APOE_R176C WT	-117.27 ng/dL Standard Error 37.3	-5.94 ng/dL Standard Error 38.5

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309 Fasting TNF-alpha: IL6_5309 WT	-1.19 pg/mL Standard Error 2.24	-2.68 pg/mL Standard Error 2.68
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309 Fasting TNF-alpha: IL6_5309 MAC	6.01 pg/mL Standard Error 1.47	1.41 pg/mL Standard Error 1.51

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679 Fasting TNF-alpha: RS11030679 WT	7.58 pg/mL Standard Error 1.72	-0.13 pg/mL Standard Error 1.73
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679 Fasting TNF-alpha: RS11030679 MAC	0.02 pg/mL Standard Error 1.72	1.27 pg/mL Standard Error 2.00

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980 SAT-to-TAT Ratio: CCDC122_5980 WT	0.03 cm^2 Standard Error 0.01	0.03 cm^2 Standard Error 0.02
Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980 SAT-to-TAT Ratio: CCDC122_5980 MAC	0.11 cm^2 Standard Error 0.02	0.02 cm^2 Standard Error 0.02

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842 VAT: BRUNOL_1842 MAC	-3.20 cm^2 Standard Error 6.18	-1.76 cm^2 Standard Error 9.32
Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842 VAT: BRUNOL_1842 WT	23.45 cm^2 Standard Error 6.55	10.38 cm^2 Standard Error 7.13

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in VAT Associated With RETN_730 VAT: RETN_730 WT	-2.95 cm^2 Standard Error 6.10	13.69 cm^2 Standard Error 8.03
Mean Change From Baseline in VAT Associated With RETN_730 VAT: RETN_730 MAC	23.29 cm^2 Standard Error 6.52	-1.05 cm^2 Standard Error 7.61

PRIMARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.
Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980 VAT-to-TAT Ratio: CCDA122_5980 MAC	-0.11 cm^2 Standard Error 0.02	-0.02 cm^2 Standard Error 0.02
Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980 VAT-to-TAT Ratio: CCDA122_5980 WT	-0.03 cm^2 Standard Error 0.01	-0.03 cm^2 Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=440 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=443 Participants 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.
Number of Participants With HIV RNA < 400 c/mL at Week 48	377 Participants	365 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=440 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=443 Participants 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.
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)	377 Participants	363 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: All treated participants with data for this parameter.

Changes from baseline in log10 HIV RNA levels were calculated.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=397 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=379 Participants 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.
Reduction of log10 HIV RNA Levels From Baseline to Week 48	-3.09 c/mL Standard Error 0.042	-3.13 c/mL Standard Error 0.037

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48.

Population: All treated participants with data for this parameter.

Mean change from baseline in CD4 cell counts was determined.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=370 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=363 Participants 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.
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48	203 c/mm^3 Standard Error 7.1	219 c/mm^3 Standard Error 7.2

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=440 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=443 Participants 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.
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 Virologic Failure, Week 48 (HIV RNA >= 400 c/mL)	27 Participants	26 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 Paired Genotypes (n = 27, 26)	17 Participants	15 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 Paired Phenotypes (n= 27, 26)	18 Participants	16 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 IAS-defined major PI substitutions (n = 17, 15)	1 Participants	0 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 Other IAS-defined PI substitutions (n = 17, 15)	6 Participants	2 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 PI phenotypic resistance (ATV/RTV FC>5.2 (n=18,16)	1 Participants	0 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 PI phenotypic resistance (LPV/RTV FC >9 (n=18, 16)	0 Participants	0 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 PI phenotypic resistance (Other PIs )(n=18, 16)	4 Participants	4 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 RTI Substitutions , TAMS (n= 17,15)	1 Participants	1 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 RTI Substitutions , M184V (n = 17,15)	3 Participants	3 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 RTI phenotypic resistance, FTC FC>3.5 (n = 18, 16)	4 Participants	3 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 RTI phenotypic resistance, TDF FC >1.4(n = 18, 16)	0 Participants	1 Participants
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 RTI phenotypic resistance, Other NRTIs(n = 18, 16)	5 Participants	5 Participants

SECONDARY outcome

Timeframe: From baseline (Day 1) to Week 48.

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48 Deaths	6 Participants	6 Participants
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48 Other SAEs	51 Participants	42 Participants
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	400 Participants	399 Participants
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 leading to discontinuation	11 Participants	15 Participants

SECONDARY outcome

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

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

Hematology abnormalities were graded per modified 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
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) Hematocrit (n= 434, 431)	0 Participants	6 Participants
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) Hemoglobin (n= 434, 431)	2 Participants	6 Participants
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) INR (n= 435, 431)	6 Participants	11 Participants
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) Neutrophils (n = 434, 431)	14 Participants	3 Participants
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) Platelets ( n= 433, 430)	5 Participants	1 Participants
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) PT (n = 435, 431)	6 Participants	16 Participants
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) WBC (n = 434, 431)	0 Participants	0 Participants

SECONDARY outcome

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

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

Laboratory measurements marked as abnormal, as per 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48 CPK (n = 435, 430)	22 Participants	20 Participants
Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48 Lipase (n = 435, 430)	6 Participants	6 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 ALT (n= 435, 431)	8 Participants	6 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 AST (n = 435, 430)	9 Participants	2 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 Albumin (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 Alkaline Phosphatase (n= 435, 430)	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 Direct Bilirubin (n = 435, 430)	37 Participants	4 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 Total Bilirubin (n = 435, 431)	146 Participants	1 Participants

SECONDARY outcome

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

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

Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48 BUN (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48 Creatinine (n = 435, 431)	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48 Phosphorus (n = 435, 431)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48 Uric acid (n = 435, 431)	0 Participants	3 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hypochloremia (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hyperkalemia (n = 435, 430)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hypokalemia (n = 435, 430)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hypernatremia (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hyponatremia (n = 435, 431)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hypocalcemia (n = 435, 431)	1 Participants	4 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hyperchloremia (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hypercarbia (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hypocarbia (n = 435, 431)	1 Participants	7 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 Hypercalcemia (n = 435, 431)	0 Participants	0 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48 Glycosuria (n = 434, 431)	4 Participants	3 Participants
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48 Proteinuria (n = 434, 431)	3 Participants	1 Participants

SECONDARY outcome

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

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

Laboratory measurements marked as abnormal, as per 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48 Total Cholesterol (n = 434, 428)	30 Participants	77 Participants
Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48 Triglycerides (n = 434, 428)	2 Participants	15 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48 Hyperglycemia (n = 434, 428)	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48 Hypoglycemia (n = 434, 428)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

Mean change in body weight from baseline was determined.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=395 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=370 Participants 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.
Mean Change in Weight From Baseline at Week 48	4.0 kg Standard Error 0.3	2.0 kg Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=393 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=370 Participants 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.
Mean Change in Body Mass Index (BMI) in Participants at Week 48	1.3 kg/m^2 Standard Error 0.10	0.8 kg/m^2 Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48.

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Mean Change in Fasting Lipid at Week 48 Fasting total Cholesterol (n=373, 337)	19 milligrams/deciliter (mg/dL) Standard Error 1.6	38 milligrams/deciliter (mg/dL) Standard Error 1.8
Mean Change in Fasting Lipid at Week 48 Fasting HDL Cholesterol (n=371, 335)	9 milligrams/deciliter (mg/dL) Standard Error 0.6	12 milligrams/deciliter (mg/dL) Standard Error 0.6
Mean Change in Fasting Lipid at Week 48 Fasting Non-HDL Cholesterol (n=371, 335)	10 milligrams/deciliter (mg/dL) Standard Error 1.5	26 milligrams/deciliter (mg/dL) Standard Error 1.7
Mean Change in Fasting Lipid at Week 48 Fasting LDL Cholesterol (n=372, 335)	12 milligrams/deciliter (mg/dL) Standard Error 1.4	18 milligrams/deciliter (mg/dL) Standard Error 1.5
Mean Change in Fasting Lipid at Week 48 Fasting Triglycerides (n=373, 337)	20 milligrams/deciliter (mg/dL) Standard Error 4.0	70 milligrams/deciliter (mg/dL) Standard Error 5.7

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48.

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

Mean change from baseline in fasting glucose at Week 48.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=383 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=363 Participants 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.
Mean Change in Fasting Glucose at Week 48	2 mg/dL Standard Error 0.6	0 mg/dL Standard Error 1.3

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48.

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

Mean change from baseline in fasting insulin at Week 48.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=371 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=352 Participants 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.
Mean Change in Fasting Insulin at Week 48	2.5 micro units (µU)/mL Standard Error 0.52	0.2 micro units (µU)/mL Standard Error 0.38

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24.

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=347 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=351 Participants 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.
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Quality of Life Subscale (327, 326)	9.9 Units on Scale Standard Error 1.32	7.1 Units on Scale Standard Error 1.29
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Physical Health Summary (317, 314)	4.1 Units on Scale Standard Error 0.46	3.3 Units on Scale Standard Error 0.46
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Mental Health Summary (317, 314)	5.3 Units on Scale Standard Error 0.50	4.8 Units on Scale Standard Error 0.52
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Overall Health Perception Subscale (325, 320)	15.2 Units on Scale Standard Error 1.31	13.0 Units on Scale Standard Error 1.41
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Physical Function Subscale (324, 325)	7.6 Units on Scale Standard Error 1.25	5.0 Units on Scale Standard Error 1.30
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Role Function Subscale (325, 325)	10.6 Units on Scale Standard Error 1.72	6.5 Units on Scale Standard Error 1.61
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Social Function Subscale (327, 322)	8.5 Units on Scale Standard Error 1.54	7.1 Units on Scale Standard Error 1.49
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Cognitive Function Subscale (326, 324)	5.6 Units on Scale Standard Error 1.11	3.0 Units on Scale Standard Error 0.94
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Pain Subscale (327, 325)	7.4 Units on Scale Standard Error 1.37	8.6 Units on Scale Standard Error 1.23
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Mental Health Subscale (325, 326)	6.4 Units on Scale Standard Error 1.09	7.4 Units on Scale Standard Error 1.08
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Energy/Fatigue Subscale (323, 326)	7.1 Units on Scale Standard Error 1.16	7.5 Units on Scale Standard Error 1.14
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Health Distress Subscale (323, 326)	14.4 Units on Scale Standard Error 1.29	13.9 Units on Scale Standard Error 1.30
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 Health Transition Subscale (327, 326)	13.1 Units on Scale Standard Error 1.64	10.7 Units on Scale Standard Error 1.55

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=347 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=351 Participants 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.
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Social Function Subscale (308, 295)	9.2 Units on Scale Standard Error 1.48	7.4 Units on Scale Standard Error 1.66
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Physical Health Summary (296, 287)	3.8 Units on Scale Standard Error 0.50	3.3 Units on Scale Standard Error 0.49
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Mental Health Summary (296, 287)	6.0 Units on Scale Standard Error 0.54	5.6 Units on Scale Standard Error 0.54
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Overall Health Perception Subscale (305, 297)	15.6 Units on Scale Standard Error 1.53	13.7 Units on Scale Standard Error 1.51
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Physical Function Subscale (303, 298)	5.8 Units on Scale Standard Error 1.28	5.3 Units on Scale Standard Error 1.24
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Cognitive Function Subscale (307, 300)	4.8 Units on Scale Standard Error 1.25	5.6 Units on Scale Standard Error 1.05
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Role Function Subscale (307, 298)	8.5 Units on Scale Standard Error 1.75	8.1 Units on Scale Standard Error 1.75
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Pain Subscale (308, 297)	8.3 Units on Scale Standard Error 1.39	8.0 Units on Scale Standard Error 1.39
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Mental Health Subscale (306, 300)	8.3 Units on Scale Standard Error 1.21	8.7 Units on Scale Standard Error 1.10
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Energy/Fatigue Subscale (304, 300)	8.4 Units on Scale Standard Error 1.25	7.9 Units on Scale Standard Error 1.21
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Health Distress Subscale (304, 300)	14.3 Units on Scale Standard Error 1.39	15.0 Units on Scale Standard Error 1.36
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Quality of Life Subscale (308, 300)	12.9 Units on Scale Standard Error 1.39	8.4 Units on Scale Standard Error 1.34
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 Health Transition Subscale (308, 300)	11.0 Units on Scale Standard Error 1.63	8.8 Units on Scale Standard Error 1.64

SECONDARY outcome

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

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=343 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=349 Participants 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.
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Overall (306, 316)	3.2 Units on Scale Standard Error 0.71	-0.7 Units on Scale Standard Error 0.66
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Dysphoria (317, 325)	3.3 Units on Scale Standard Error 0.79	-0.1 Units on Scale Standard Error 0.75
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Interference with activity (319, 327)	3.1 Units on Scale Standard Error 0.86	-1.9 Units on Scale Standard Error 0.79
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Body image (321, 329)	1.6 Units on Scale Standard Error 0.71	-1.3 Units on Scale Standard Error 0.68
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Health worry (319, 330)	6.0 Units on Scale Standard Error 0.96	2.0 Units on Scale Standard Error 0.99
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Food avoidance (319, 329)	4.0 Units on Scale Standard Error 1.03	-1.7 Units on Scale Standard Error 1.07
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Social reaction (316, 327)	1.9 Units on Scale Standard Error 0.76	-0.8 Units on Scale Standard Error 0.71
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Sexual (320, 329)	3.7 Units on Scale Standard Error 1.06	-0.1 Units on Scale Standard Error 1.02
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) Relationships (321, 328)	1.2 Units on Scale Standard Error 0.72	-0.6 Units on Scale Standard Error 0.75

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=343 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=349 Participants 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.
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Overall (301. 310)	4.6 Units on Scale Standard Error 0.69	0.2 Units on Scale Standard Error 0.89
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Dysphoria (308, 319)	4.7 Units on Scale Standard Error 0.79	1.2 Units on Scale Standard Error 0.94
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Interference with activity (310, 320)	5.1 Units on Scale Standard Error 0.83	-0.4 Units on Scale Standard Error 0.96
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Body image (316, 321)	2.1 Units on Scale Standard Error 0.69	-0.1 Units on Scale Standard Error 0.85
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Health worry (312, 320)	7.9 Units on Scale Standard Error 1.02	3.6 Units on Scale Standard Error 1.23
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Food avoidance (316, 322)	5.6 Units on Scale Standard Error 0.95	-0.6 Units on Scale Standard Error 1.25
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Social reaction (311, 316)	3.3 Units on Scale Standard Error 0.73	-0.4 Units on Scale Standard Error 0.95
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Sexual (317, 321)	4.7 Units on Scale Standard Error 1.11	-0.4 Units on Scale Standard Error 1.19
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) Relationships (313, 320)	3.5 Units on Scale Standard Error 0.75	0.0 Units on Scale Standard Error 0.99

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=343 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=349 Participants 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.
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) Overall (290, 289)	4.3 Units on a scale Standard Error 0.77	1.4 Units on a scale Standard Error 0.88
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) Dysphoria (295, 298)	4.4 Units on a scale Standard Error 0.84	1.8 Units on a scale Standard Error 0.97
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) Interference with activity (294, 297)	4.4 Units on a scale Standard Error 0.92	0.0 Units on a scale Standard Error 1.04
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) Body image (299, 300)	1.8 Units on a scale Standard Error 0.80	1.1 Units on a scale Standard Error 0.84
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) Health worry (297, 300)	7.5 Units on a scale Standard Error 0.99	5.3 Units on a scale Standard Error 1.18
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) Food avoidance (299, 300)	5.6 Units on a scale Standard Error 1.14	0.4 Units on a scale Standard Error 1.29
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) Social reaction (295, 297)	3.2 Units on a scale Standard Error 0.80	0.4 Units on a scale Standard Error 0.92
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) Sexual (299, 299)	4.3 Units on a scale Standard Error 1.20	0.8 Units on a scale Standard Error 1.15
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) Relationships (297, 297)	3.3 Units on a scale Standard Error 0.89	1.2 Units on a scale Standard Error 1.00

SECONDARY outcome

Timeframe: Week 48

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=401 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=378 Participants 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.
Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48	330 Participants	316 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=440 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=443 Participants 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.
Number of Participants With HIV RNA < 50 c/mL) at Week 96	327 Participants	302 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=440 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=443 Participants 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.
Number of Participants With HIV RNA < 400 c/mL) at Week 96	350 Participants	330 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

Changes from baseline in log10 HIV RNA levels were calculated.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=360 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=340 Participants 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.
Reduction of log10 HIV RNA Levels From Baseline at Week 96	-3.21 c/mL Standard Error 0.034	-3.19 c/mL Standard Error 0.036

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=336 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=317 Participants 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.
Mean Change From Baseline in CD4 Cell Count at Week 96	268 cells/mm^3 Standard Error 7.6	290 cells/mm^3 Standard Error 8.7

SECONDARY outcome

Timeframe: From Day 1 through Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 Deaths	6 Participants	6 Participants
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 Serious Adverse Events (SAEs)	63 Participants	50 Participants
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 Adverse Events (AEs) leading to discontinuation	13 Participants	22 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Mean Changes in Fasting Lipids at Week 96 Fasting total Cholesterol (n=342, 291)	20 mg/dL Standard Error 1.8	37 mg/dL Standard Error 1.8
Mean Changes in Fasting Lipids at Week 96 Fasting HDL Cholesterol (n=341, 291)	7.0 mg/dL Standard Error 0.6	10.0 mg/dL Standard Error 0.7
Mean Changes in Fasting Lipids at Week 96 Fasting Non-HDL Cholesterol (n=341, 291)	13.0 mg/dL Standard Error 1.6	27.0 mg/dL Standard Error 1.7
Mean Changes in Fasting Lipids at Week 96 Fasting LDL Cholesterol (n=342, 291)	12.0 mg/dL Standard Error 1.5	17.0 mg/dL Standard Error 1.5
Mean Changes in Fasting Lipids at Week 96 Fasting Triglycerides (n=342, 291)	16.0 mg/dL Standard Error 4.4	63.0 mg/dL Standard Error 5.4

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=355 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=330 Participants 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.
Mean Changes in Fasting Glucose at Week 96	4.0 mg/dL Standard Error 1.2	1.0 mg/dL Standard Error 1.4

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96.

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

Mean change from baseline in fasting insulin at Week 96.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=349 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=324 Participants 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.
Mean Changes in Fasting Insulin at Week 96	0.1 µU/mL Standard Error 0.47	-0.8 µU/mL Standard Error 0.43

SECONDARY outcome

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

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

Hematology abnormalities were graded per modified 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 WBC (n = 434, 431)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 Hematocrit (n= 434, 431)	0 Participants	6 Participants
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 Hemoglobin (n= 434, 431)	3 Participants	7 Participants
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 INR (n= 435, 431)	7 Participants	18 Participants
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 Neutrophils (n = 434, 431)	21 Participants	7 Participants
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 Platelets ( n= 433, 431)	5 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 Prothrombin time (n = 435, 431)	9 Participants	24 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96 CPK (n=435, 430)	34 Participants	28 Participants
Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96 Lipase (n=435, 430)	9 Participants	9 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96 ALT (n= 435, 431)	11 Participants	7 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96 AST (n = 435, 430)	11 Participants	5 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96 Albumin (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96 Alkaline Phosphatase (n= 435, 430)	1 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96 Total Bilirubin (n = 435, 431)	192 Participants	3 Participants

SECONDARY outcome

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

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

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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96 BUN (n = 435,431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96 Creatine (n = 435, 431)	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96 Phosphorous (n = 435, 431)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96 Uric acid (n = 435, 431)	1 Participants	4 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hypercarbia (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hypocarbia (n = 435, 431)	4 Participants	8 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hypercalcemia (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hypocalcemia (n = 435, 431)	1 Participants	4 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hyperchloremia (n = 435, 431)	0 Participants	0 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hypochloremia (n = 435, 431)	0 Participants	2 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hyperkalemia (n = 435, 430)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hypokalemia (n = 435, 430)	0 Participants	1 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hypernatremia (n = 435, 431)	1 Participants	2 Participants
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 Hyponatremia (n = 435, 431)	0 Participants	2 Participants

SECONDARY outcome

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

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

Laboratory measurements marked as abnormal, as per 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96 Total Cholesterol (n = 434, 428)	47 Participants	108 Participants
Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96 Triglycerides (n = 434, 428)	3 Participants	18 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96 Hyperglycemia (n = 434, 428)	3 Participants	2 Participants
Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96 Hypoglycemia (n = 434, 428)	1 Participants	0 Participants

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=441 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=437 Participants 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.
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96 Glycosuria (n = 434, 431)	6 Participants	5 Participants
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96 Proteinuria (n = 434, 431)	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96.

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=438 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=443 Participants 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.
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 Virologic Failure, Week 96 (HIV RNA >= 400 c/mL)	28 Participants	29 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 Paired Genotypes (n = 28, 29)	26 Participants	26 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 Paired Phenotypes (n= 28, 29)	25 Participants	23 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 IAS-USA major PI substitutions (n = 26, 26)	1 Participants	0 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 IAS-USA minor PI substitutions (n = 26, 26)	1 Participants	1 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 PI polymorphisms without IAS-USA (n=26, 26)	11 Participants	14 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 PI phenotypic resistance (ATV/RTV FC >5.2 (25, 23)	1 Participants	0 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 PI phenotypic resistance (LPV/RTV FC>9 (25,23)	0 Participants	1 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 PI phenotypic resistance (Other PIs [25, 23])	3 Participants	6 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 NRTI substitutions (TAMS [26, 26])	1 Participants	3 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 NRTI substitutions (M184I/V [26, 26])	5 Participants	7 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 RTI phenotypic resistance (FC [n = 25, 23])	5 Participants	5 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 RTI phenotypic resistance (TDF [n = 25, 23])	0 Participants	2 Participants
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 RTI phenotypic resistance (Other NRTI [n =25, 23])	5 Participants	6 Participants

SECONDARY outcome

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

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

Mean 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=118 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=81 Participants 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.
Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48	0.04 Ratio Standard Error 0.013	-0.02 Ratio Standard Error 0.014

SECONDARY outcome

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

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

The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=118 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=82 Participants 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.
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48 Trunk Fat	26 Percentage Interval 18.9 to 34.5	16 Percentage Interval 9.4 to 22.2
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48 Limb Fat	22 Percentage Interval 15.7 to 28.9	17 Percentage Interval 11.2 to 23.1
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48 Total Body Fat	23 Percentage Interval 16.7 to 29.9	15 Percentage Interval 9.8 to 21.1

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96.

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

The 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.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=106 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=71 Participants 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.
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96 Trunk Fat	34 Percentage Interval 23.9 to 44.8	16 Percentage Interval 8.0 to 24.0
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96 Limb Fat	27 Percentage Interval 18.7 to 36.3	15 Percentage Interval 8.3 to 22.6
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96 Total Body Fat	29 Percentage Interval 20.5 to 38.3	15 Percentage Interval 8.0 to 22.2

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96.

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=125 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.
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 Trunk-to-Limb Fat Ratio (n = 106, 71)	0.05 Ratio Interval 0.02 to 0.08	0.00 Ratio Interval -0.03 to 0.03
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 VAT-to-TAT Ratio (n = 95,68)	-0.04 Ratio Interval -0.06 to -0.02	-0.02 Ratio Interval -0.04 to 0.0
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 VAT-to-SAT Ratio (n = 95, 68)	-0.22 Ratio Interval -0.41 to -0.04	-0.09 Ratio Interval -0.18 to 0.0

SECONDARY outcome

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

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=118 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=82 Participants 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.
Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48 Bone Mineral Density of Both Arms	-1 grams/ centimeters ^2 (g/cm^2) Interval -1.9 to -0.4	-1 grams/ centimeters ^2 (g/cm^2) Interval -2.1 to -0.4
Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48 Bone Mineral Density of Both Legs	-2 grams/ centimeters ^2 (g/cm^2) Interval -2.0 to -1.1	-2 grams/ centimeters ^2 (g/cm^2) Interval -2.4 to -1.4
Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48 Bone Mineral Density of Trunk	-4 grams/ centimeters ^2 (g/cm^2) Interval -4.3 to -3.0	-4 grams/ centimeters ^2 (g/cm^2) Interval -5.2 to -3.4
Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48 Bone Mineral Density of Total Body	-2 grams/ centimeters ^2 (g/cm^2) Interval -2.7 to -1.7	-3 grams/ centimeters ^2 (g/cm^2) Interval -3.1 to -2.1

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=106 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=70 Participants 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.
Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96 Bone Mineral Density of Both Arms	-1 g/cm^2 Interval -2.3 to -0.5	-2 g/cm^2 Interval -3.2 to -1.2
Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96 Bone Mineral Density of Both Legs	-2 g/cm^2 Interval -2.7 to -1.1	-3 g/cm^2 Interval -3.4 to -1.9
Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96 Bone Mineral Density of Trunk	-3 g/cm^2 Interval -3.7 to -1.9	-5 g/cm^2 Interval -5.7 to -3.5
Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96 Bone Mineral Density of Total Body	-3 g/cm^2 Interval -3.4 to -1.9	-4 g/cm^2 Interval -4.5 to -2.9

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

Mean change from baseline in weight at Week 96

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=361 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=338 Participants 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.
Mean Change From Baseline in Body Weight at Week 96	5 kg Standard Error 0.4	3 kg Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=118 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=85 Participants 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.
Mean Change From Baseline in Body Weight at Week 48	4 kg Standard Error 0.5	3 kg Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=359 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=338 Participants 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.
Mean Change From Baseline in BMI at Week 96	1.6 kg/m^2 Standard Error 0.13	1.0 kg/m^2 Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96.

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=100 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=71 Participants 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.
Mean Change From Baseline in Waist Circumference at Week 96	6 cm Standard Error 0.8	2 cm Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=109 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=77 Participants 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.
Mean Change From Baseline in Waist Circumference at Week 48	4 cm Standard Error 0.6	2 cm Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=99 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=71 Participants 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.
Mean Change From Baseline in Waist-to-hip-ratio at Week 96	0.02 ratio Standard Error 0.006	0.01 ratio Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48.

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=118 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=85 Participants 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.
Mean Change From Baseline in BMI at Week 48	1.5 kg/m^2 Standard Error 0.19	1.1 kg/m^2 Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=108 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=77 Participants 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.
Mean Change From Baseline in Waist-to-hip-ratio at Week 48	0.02 ratio Standard Error 0.008	0.01 ratio Standard Error 0.008

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=106 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=70 Participants 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.
Percentage of Participants With Lipoatrophy at Week 96	5 percentage of participants	7 percentage of participants

SECONDARY outcome

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

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

Mean change in body weight from baseline was determined.

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=110 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=78 Participants 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.
Mean Changes From Baseline in Body Weight at Week 96	6 kg Standard Error 0.7	3 kg Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

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

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

Outcome measures

Measure	ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD n=110 Participants 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.	LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD n=78 Participants 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.
Mean Change From Baseline in BMI at Week 96	2.0 kg/m^2 Standard Error 0.26	1.2 kg/m^2 Standard Error 0.28

Adverse Events

ATV/RTV/Tenofovir/Emtricitabine

Serious events: 61 serious events

Other events: 355 other events

Deaths: 0 deaths

LPV/RTV/Tenofovir/Emtricitabine

Serious events: 48 serious events

Other events: 370 other events

Deaths: 0 deaths

Serious adverse events

Measure	ATV/RTV/Tenofovir/Emtricitabine n=441 participants at risk 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.	LPV/RTV/Tenofovir/Emtricitabine n=437 participants at risk 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.
Investigations WEIGHT DECREASED	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.69% 3/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Investigations HEPATIC ENZYME INCREASED	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Cardiac disorders CARDIAC ARREST	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Psychiatric disorders ANXIETY	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Psychiatric disorders DEPRESSION	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Psychiatric disorders SUICIDE ATTEMPT	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Psychiatric disorders BIPOLAR DISORDER	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Psychiatric disorders SUICIDAL IDEATION	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Hepatobiliary disorders CHOLANGITIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Hepatobiliary disorders CHOLESTASIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Hepatobiliary disorders CHOLECYSTITIS	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Hepatobiliary disorders CHOLELITHIASIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Hepatobiliary disorders HEPATORENAL SYNDROME	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Immune system disorders HYPERSENSITIVITY	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Immune system disorders IMMUNE RECONSTITUTION SYNDROME	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Nervous system disorders HEADACHE	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Nervous system disorders COMPLEX REGIONAL PAIN SYNDROME	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders NAUSEA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders ASCITES	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders COLITIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders VOMITING	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.46% 2/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders DIARRHOEA	0.68% 3/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	1.4% 6/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders ENTERITIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders COLONIC STENOSIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders MESENTERIC ARTERY THROMBOSIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations INFECTION	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PNEUMONIA	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.69% 3/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations SINUSITIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations CELLULITIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations ERYSIPELAS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations MENINGITIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations CANDIDIASIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations ORAL HERPES	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PHARYNGITIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations TONSILLITIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations ABSCESS LIMB	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations APPENDICITIS	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations TUBERCULOSIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations SALMONELLOSIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations TOXOPLASMOSIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PYELONEPHRITIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations LOBAR PNEUMONIA	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations BRONCHOPNEUMONIA	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations BULLOUS IMPETIGO	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PERIANAL ABSCESS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PERIRECTAL ABSCESS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations MENINGITIS BACTERIAL	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations SUBCUTANEOUS ABSCESS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations CEREBRAL TOXOPLASMOSIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PULMONARY TUBERCULOSIS	0.68% 3/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.46% 2/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations MENINGITIS CRYPTOCOCCAL	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations CYTOMEGALOVIRUS INFECTION	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations DISSEMINATED TUBERCULOSIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PARASITIC GASTROENTERITIS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations EXTRAPULMONARY TUBERCULOSIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PELVIC INFLAMMATORY DISEASE	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PNEUMOCYSTIS JIROVECI PNEUMONIA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.46% 2/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations MYCOBACTERIUM AVIUM COMPLEX INFECTION	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.46% 2/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Renal and urinary disorders RENAL FAILURE	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Renal and urinary disorders URINARY RETENTION	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Metabolism and nutrition disorders GOUT	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Metabolism and nutrition disorders DEHYDRATION	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.69% 3/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Metabolism and nutrition disorders HYPERLIPIDAEMIA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Metabolism and nutrition disorders HYPERLACTACIDAEMIA	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Blood and lymphatic system disorders LYMPH NODE PAIN	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Reproductive system and breast disorders ADNEXA UTERI MASS	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Congenital, familial and genetic disorders FANCONI SYNDROME	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications INJURY	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications HEAD INJURY	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications CHEST INJURY	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications JAW FRACTURE	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications HAND FRACTURE	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications GUN SHOT WOUND	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications TIBIA FRACTURE	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications WRIST FRACTURE	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications ERGOT POISONING	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications MULTIPLE INJURIES	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders BACK PAIN	0.45% 2/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders SACROILIITIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
General disorders OEDEMA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
General disorders PYREXIA	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.69% 3/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
General disorders ASTHENIA	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
General disorders CHEST PAIN	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
General disorders MULTI-ORGAN FAILURE	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MEDULLOBLASTOMA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CARCINOMA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) KAPOSI'S SARCOMA	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.46% 2/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TESTICULAR NEOPLASM	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.00% 0/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.23% 1/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DIFFUSE LARGE B-CELL LYMPHOMA	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BENIGN MALE REPRODUCTIVE TRACT NEOPLASM	0.23% 1/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.

Other adverse events

Measure	ATV/RTV/Tenofovir/Emtricitabine n=441 participants at risk 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.	LPV/RTV/Tenofovir/Emtricitabine n=437 participants at risk 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.
Eye disorders OCULAR ICTERUS	9.8% 43/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.00% 0/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Hepatobiliary disorders JAUNDICE	18.8% 83/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.46% 2/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Hepatobiliary disorders HYPERBILIRUBINAEMIA	11.6% 51/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	0.69% 3/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Nervous system disorders HEADACHE	18.4% 81/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	15.3% 67/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Nervous system disorders DIZZINESS	7.7% 34/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	6.6% 29/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders NAUSEA	16.6% 73/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	23.6% 103/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders VOMITING	7.7% 34/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	11.0% 48/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders DIARRHOEA	24.5% 108/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	54.0% 236/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders DYSPEPSIA	5.4% 24/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	6.2% 27/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Gastrointestinal disorders ABDOMINAL PAIN	6.8% 30/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	7.1% 31/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations INFLUENZA	7.5% 33/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	7.6% 33/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations BRONCHITIS	8.4% 37/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	6.6% 29/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations PHARYNGITIS	3.9% 17/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	5.3% 23/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations HERPES ZOSTER	4.3% 19/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	5.0% 22/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations NASOPHARYNGITIS	15.0% 66/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	16.7% 73/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations URINARY TRACT INFECTION	5.4% 24/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	5.0% 22/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	8.4% 37/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	12.4% 54/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	4.3% 19/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	11.0% 48/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Skin and subcutaneous tissue disorders RASH	6.1% 27/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	4.3% 19/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders BACK PAIN	8.6% 38/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	3.2% 14/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.3% 32/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	4.6% 20/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
Respiratory, thoracic and mediastinal disorders COUGH	6.3% 28/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	7.8% 34/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.
General disorders PYREXIA	5.7% 25/441 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.	6.4% 28/437 Number of SAEs presented here differs from those in Outcome Measures, as the treated population was used for this section, not the all enrolled population that was used for the Outcome Measures. The number of AEs presented here also differs from those in the Outcome Measure, as the AEs here do not include SAEs.

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: ClinicalTrials@bms.com

Results disclosure agreements

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

Restriction type: OTHER