Trial Outcomes & Findings for Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV (NCT NCT00035932)

NCT ID: NCT00035932

Last Updated: 2010-12-24

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

571 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2010-12-24

Participant Flow

571 human immunodeficiency virus (HIV)-infected participants were enrolled; 358 (63%) were randomized to treatment. Of the 213 not randomized, 194 did not meet eligibility criteria; other reasons include duplicate enrollment (4), accrual closed (1), noncompliance (1), serious adverse event (2), patient request (11), missing information (4).

Participant milestones

Participant milestones
Measure	ATV 300 mg / RTV atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Overall Study STARTED	119	110	118
Overall Study Discontinued Prior to Week 48 Visit	26	29	13
Overall Study Discontinued Between Weeks 48 and 96	26	27	30
Overall Study Discontinued on or After Week 96	4	4	6
Overall Study COMPLETED	63	50	69
Overall Study NOT COMPLETED	56	60	49

Reasons for withdrawal

Reasons for withdrawal
Measure	ATV 300 mg / RTV atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Overall Study Adverse Event	10	9	9
Overall Study Death	0	0	1
Overall Study Disease Progression / Relapse	1	1	0
Overall Study Lost to Follow-up	4	4	3
Overall Study Noncompliance	6	7	6
Overall Study Protocol Violation While on Study	0	1	2
Overall Study Withdrawal by Subject	1	5	0
Overall Study Study Termination by Sponsor	1	0	0
Overall Study Lack of Efficacy	33	33	28

Baseline Characteristics

Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	Total n=358 Participants Total of all reporting groups
Age Continuous	39 years n=5 Participants	41 years n=7 Participants	39 years n=5 Participants	40 years n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants	77 Participants n=4 Participants
Sex: Female, Male Male	96 Participants n=5 Participants	89 Participants n=7 Participants	96 Participants n=5 Participants	281 Participants n=4 Participants
Race/Ethnicity, Customized White	75 participants n=5 Participants	70 participants n=7 Participants	71 participants n=5 Participants	216 participants n=4 Participants
Race/Ethnicity, Customized Hispanic/Latino	27 participants n=5 Participants	26 participants n=7 Participants	27 participants n=5 Participants	80 participants n=4 Participants
Race/Ethnicity, Customized Black	18 participants n=5 Participants	16 participants n=7 Participants	21 participants n=5 Participants	55 participants n=4 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants
Region of Enrollment South America	56 participants n=5 Participants	55 participants n=7 Participants	54 participants n=5 Participants	165 participants n=4 Participants
Region of Enrollment North America	39 participants n=5 Participants	38 participants n=7 Participants	47 participants n=5 Participants	124 participants n=4 Participants
Region of Enrollment Europe	25 participants n=5 Participants	22 participants n=7 Participants	22 participants n=5 Participants	69 participants n=4 Participants
Acquired Immunodeficiency Virus (AIDS) Yes	33 participants n=5 Participants	33 participants n=7 Participants	36 participants n=5 Participants	102 participants n=4 Participants
Acquired Immunodeficiency Virus (AIDS) No	87 participants n=5 Participants	82 participants n=7 Participants	87 participants n=5 Participants	256 participants n=4 Participants
Intravenous (IV) Drug Use Yes	8 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants	23 participants n=4 Participants
Intravenous (IV) Drug Use No	112 participants n=5 Participants	108 participants n=7 Participants	115 participants n=5 Participants	335 participants n=4 Participants
Cluster of Differentiation 4 (CD4) cell count	317 cells/mm^3 n=5 Participants	286 cells/mm^3 n=7 Participants	283 cells/mm^3 n=5 Participants	297 cells/mm^3 n=4 Participants
Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA)	4.44 log10 c/mL n=5 Participants	4.42 log10 c/mL n=7 Participants	4.47 log10 c/mL n=5 Participants	4.45 log10 c/mL n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24	-1.86 log10 c/mL Standard Error 0.11	-1.52 log10 c/mL Standard Error 0.13	-1.89 log10 c/mL Standard Error 0.11

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Mean Change From Baseline in HIV RNA at Week 48	-1.93 log10 c/mL Standard Error 0.12	-1.55 log10 c/mL Standard Error 0.14	-1.87 log10 c/mL Standard Error 0.13

PRIMARY outcome

Timeframe: Baseline, Week 96

Population: Randomized participants while on initial regimen

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=64 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=65 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Mean Change From Baseline in HIV RNA at Week 96	-2.29 log10 c/mL Standard Error 0.121	-2.08 log10 c/mL Standard Error 0.151	—

SECONDARY outcome

Timeframe: Baseline, Week 2

Population: Treated participants, as-randomized (refers to the treatment regimen assigned at randomization).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Mean Change From Baseline in HIV RNA at Week 2	-1.18 log10 c/mL Standard Error 0.06	-1.14 log10 c/mL Standard Error 0.07	-1.30 log10 c/mL Standard Error 0.06

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=number of evaluable (overall, PI sensitive, PI resistant) participants.

Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) Overall (n=120, 115, 123)	95 participants	74 participants	93 participants
Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) PI Sensitive (n=88, 83, 88)	79 participants	58 participants	72 participants
Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity) PI Resistant (n=32, 30, 33)	16 participants	15 participants	19 participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).n=number of evaluable (overall, PI sensitive, PI resistant) participants.

Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity) PI Sensitive (n=88, 84, 88)	65 participants	52 participants	67 participants
Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity) Overall (n=120, 115, 123)	77 participants	60 participants	84 participants
Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity) PI Resistant (n=32, 30, 33)	12 participants	7 participants	16 participants

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement.

Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 400 c/mL at Week 96.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=113 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96	61 participants	58 participants	—

SECONDARY outcome

Timeframe: Week 24

Population: Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24	95 participants	74 participants	93 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ \< 50 on the primary endpoint, and to run LOQ\<400 for subsets such as baseline PI sensitivity.

Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48

Population: Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48	76 Participants	60 Participants	84 Participants

SECONDARY outcome

Timeframe: Baseline, Week 48

Number of participants with a \>=0.5 log10 decrease in HIV RNA from baseline or HIV RNA \< 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 96

Population: Randomized participants while on initial regimen (completers censored).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=113 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96	61 Participants	57 Participants	—

SECONDARY outcome

Timeframe: Week 24

Population: Randomized participants while on initial regimen Randomized participants, (completers censored).

Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24	76 participants	50 participants	74 participants

SECONDARY outcome

Timeframe: Week 48

Population: Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48	64 participants	42 participants	67 participants

SECONDARY outcome

Timeframe: Week 96

Population: Randomized participants while on initial regimen (completers censored).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=116 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96	52 participants	53 participants	—

SECONDARY outcome

Timeframe: Week 24

Population: Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).

Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24	46 participants	25 participants	50 participants

SECONDARY outcome

Timeframe: Week 48

Population: Randomized participantsRandomized participants while on initial regimen (completers censored).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48	43 participants	28 participants	52 participants

SECONDARY outcome

Timeframe: Week 96

Population: Randomized participants while on initial regimen (completers censored)

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=118 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96	38 participants	41 participants	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Randomized participantsRandomized participants while on initial regimen (completers censored).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Change From Baseline in CD4 Cell Count at Week 24	83 cells/mm3 Standard Error 14.0	59 cells/mm3 Standard Error 11.8	90 cells/mm3 Standard Error 15.3

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Randomized participants while on initial regimen (completers censored).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Change From Baseline in CD4 Cell Count at Week 48	110 cells/mm3 Standard Error 22.9	72 cells/mm3 Standard Error 19.7	121 cells/mm3 Standard Error 20.1

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Randomized participants (while on initial regimen) with evaluation at time point

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=60 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=60 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Change From Baseline in CD4 Cell Count at Week 96	122 cells/mm3 Standard Error 26.3	154 cells/mm3 Standard Error 24.2	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Week 24: Participants with evaluable PK measurements

Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=40 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=23 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24 ATV Cmin	-0.056 Pearson Correlation Coefficient	0.254 Pearson Correlation Coefficient	—
Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24 IQ (<10; >=10)	-0.391 Pearson Correlation Coefficient	-0.081 Pearson Correlation Coefficient	—
Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24 # of PI Mutations at baseline (<4; >=4)	0.306 Pearson Correlation Coefficient	0.437 Pearson Correlation Coefficient	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants with evaluable PK measurements, as-randomized population (refers to the treatment regimen assigned at randomization).

Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=40 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=23 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24 ATV Cmin	0.37 Pearson Correlation Coefficient	-0.21 Pearson Correlation Coefficient	—
Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24 IQ (<10; >=10)	0.376 Pearson Correlation Coefficient	0.105 Pearson Correlation Coefficient	—
Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24 # of PI Mutations at baseline (<4; >=4)	-0.395 Pearson Correlation Coefficient	-0.227 Pearson Correlation Coefficient	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Treated Participants, Last Observation Carried Forward (LOCF), as-randomized population (refers to the treatment regimen assigned at randomization).

Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=110 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Lipid Mean Percent Change From Baseline at Week 24 Total Cholesterol	-8 percent change	-9 percent change	3 percent change
Lipid Mean Percent Change From Baseline at Week 24 High Density Lipoprotein (HDL) Cholesterol	-7 percent change	-1 percent change	0 percent change
Lipid Mean Percent Change From Baseline at Week 24 Fasting Low Density Lipoprotein (LDL) Cholesterol	-10 percent change	-11 percent change	-4 percent change
Lipid Mean Percent Change From Baseline at Week 24 Fasting Triglycerides	-2 percent change	-14 percent change	31 percent change

SECONDARY outcome

Timeframe: Week 48

Population: Treated Participants, Last Observation Carried Forward (LOCF); as-randomized population (refers to the treatment regimen assigned at randomization).

Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=110 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Lipid Mean Percent Change From Baseline at Week 48 Total Cholesterol	-8 percent change in lipid values	-4 percent change in lipid values	6 percent change in lipid values
Lipid Mean Percent Change From Baseline at Week 48 HDL Cholesterol	-7 percent change in lipid values	4 percent change in lipid values	2 percent change in lipid values
Lipid Mean Percent Change From Baseline at Week 48 Fasting LDL Cholesterol	-10 percent change in lipid values	-3 percent change in lipid values	1 percent change in lipid values
Lipid Mean Percent Change From Baseline at Week 48 Fasting Triglycerides	-4 percent change in lipid values	-14 percent change in lipid values	30 percent change in lipid values

SECONDARY outcome

Timeframe: Week 96

Population: Treated Participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=110 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Lipid Mean Percent Change From Baseline at Week 96, Observed Values Total Cholesterol (n=60, 46, 54)	-7 percent change in lipid values	-1 percent change in lipid values	9 percent change in lipid values
Lipid Mean Percent Change From Baseline at Week 96, Observed Values HDL Cholesterol (n=60, 46, 54)	-5 percent change in lipid values	3 percent change in lipid values	7 percent change in lipid values
Lipid Mean Percent Change From Baseline at Week 96, Observed Values Fasting LDL Cholesterol (n=52, 39, 43)	-11 percent change in lipid values	-7 percent change in lipid values	1 percent change in lipid values
Lipid Mean Percent Change From Baseline at Week 96, Observed Values Fasting Triglycerides (n=52, 40, 43)	-2 percent change in lipid values	4 percent change in lipid values	30 percent change in lipid values

SECONDARY outcome

Timeframe: From Enrollment through Week 48

Population: Randomized participants for Deaths and SAEs; treated participants for all others; as-randomized population (refers to the treatment regimen assigned at randomization). In addition, of the 213 screen failures (not randomized), there were 4 subjects who had an SAE; these are not included in the table below.

AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=120 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=115 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=123 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48 Deaths (n = 120, 115, 123)	0 participants	1 participants	1 participants
Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48 AEs leading to discontinuation (n = 119, 110, 118)	6 participants	8 participants	5 participants
Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48 SAEs (n = 120, 115, 123)	12 participants	14 participants	11 participants
Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48 AEs, grades 1-4 (n = 119, 110, 118)	97 participants	93 participants	103 participants
Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48 AEs, grades 3-4 (n = 119, 110, 118)	11 participants	18 participants	12 participants

SECONDARY outcome

Timeframe: From Enrollment to Week 48

Population: Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=110 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Most Common AEs and AEs of Interest Through Week 48 Jaundice (AE of Interest)	19 participants	6 participants	0 participants
Most Common AEs and AEs of Interest Through Week 48 Ocular Icterus (AE of Interest)	13 participants	3 participants	0 participants
Most Common AEs and AEs of Interest Through Week 48 Hyperbilirubinemia (AE of Interest)	24 participants	8 participants	1 participants
Most Common AEs and AEs of Interest Through Week 48 Diarrhea (Most Common)	25 participants	29 participants	54 participants
Most Common AEs and AEs of Interest Through Week 48 Headache (Most Common)	21 participants	24 participants	18 participants
Most Common AEs and AEs of Interest Through Week 48 Nausea (Most Common)	19 participants	24 participants	15 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=104 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=87 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=99 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Fasting Glucose Mean Change From Baseline at Week 24	0 mg/dL Standard Error 1.6	-3 mg/dL Standard Error 1.8	0 mg/dL Standard Error 1.4

SECONDARY outcome

Timeframe: Week 48

Population: Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=115 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=108 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=112 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Fasting Glucose Mean Change From Baseline at Week 48	4 mg/dL Standard Error 3.6	-1 mg/dL Standard Error 1.6	1 mg/dL Standard Error 1.5

SECONDARY outcome

Timeframe: From Enrollment to Week 48

Population: Evaluable treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to \<750/mm3 (grade 3), \<500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), \<20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), \>10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), \>10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), \>5 x ULN (grade 4).

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=108 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Grade 3/4 Laboratory Abnormalities Through Week 48 ALT Elevation	5 participants	4 participants	4 participants
Grade 3/4 Laboratory Abnormalities Through Week 48 Neutrophil Reduction	8 participants	8 participants	10 participants
Grade 3/4 Laboratory Abnormalities Through Week 48 Platelet Reduction	2 participants	4 participants	3 participants
Grade 3/4 Laboratory Abnormalities Through Week 48 AST Elevation	4 participants	2 participants	4 participants
Grade 3/4 Laboratory Abnormalities Through Week 48 Total Bilirubin Elevation	58 participants	22 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48

Population: Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint

The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=110 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point Baseline Mean (n=119, 110, 118)	390 msec Standard Error 1.9	387 msec Standard Error 2.2	390 msec Standard Error 1.9
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point Mean Change at Week 4 predose (n=117, 104, 110)	-3 msec Standard Error 1.6	1 msec Standard Error 1.9	-2 msec Standard Error 1.7
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point Mean Change Wk 4 2-3 hrs postdose (n=113,102,106)	-2 msec Standard Error 1.6	-3 msec Standard Error 2.0	-7 msec Standard Error 1.9
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point Mean Change Wk 4 6-12 hrs postdose (n=112,101,105)	-4 msec Standard Error 1.7	-1 msec Standard Error 1.9	-8 msec Standard Error 1.8
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point Mean Change at Week 12 (n=110, 97, 107)	2 msec Standard Error 1.6	3 msec Standard Error 2.0	2 msec Standard Error 1.6
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point Mean Change at Week 24 (n=108, 92, 109)	1 msec Standard Error 1.8	3 msec Standard Error 2.2	2 msec Standard Error 1.8
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point Mean Change at Week 48 (n=89, 75, 97)	-1 msec Standard Error 1.8	-1 msec Standard Error 2.1	0 msec Standard Error 2.0

SECONDARY outcome

Timeframe: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48

Population: Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint

The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=110 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
PR Interval and Change From Baseline by Analysis Time Point Baseline Mean (n=119, 110, 118)	153 msec Standard Error 1.7	155 msec Standard Error 1.9	154 msec Standard Error 1.7
PR Interval and Change From Baseline by Analysis Time Point Mean Change at Week 4 predose (n=117, 104, 110)	4 msec Standard Error 1.2	9 msec Standard Error 1.6	3 msec Standard Error 1.4
PR Interval and Change From Baseline by Analysis Time Point Mean Change Wk 4 2-3 hrs postdose (n=113,102,106)	1 msec Standard Error 1.3	6 msec Standard Error 1.6	1 msec Standard Error 1.7
PR Interval and Change From Baseline by Analysis Time Point Mean Change Wk 4 6-12 hrs postdose (n=112,101,105)	2 msec Standard Error 1.4	6 msec Standard Error 1.7	2 msec Standard Error 1.5
PR Interval and Change From Baseline by Analysis Time Point Mean Change at Week 12 (n=110, 97, 107)	5 msec Standard Error 1.6	7 msec Standard Error 1.7	8 msec Standard Error 1.4
PR Interval and Change From Baseline by Analysis Time Point Mean Change at Week 24 (n=108, 92, 109)	2 msec Standard Error 1.3	7 msec Standard Error 1.7	5 msec Standard Error 1.6
PR Interval and Change From Baseline by Analysis Time Point Mean Change at Week 48 (n=89, 75, 97)	0 msec Standard Error 1.5	2 msec Standard Error 1.9	4 msec Standard Error 1.7

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 48

Population: Number of Participants Analyzed=treated participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=subset of treated participants (Given the language limitation, a subset of the AI424045 population was included in the MACS adherence analysis.)

The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. 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

Outcome measures
Measure	ATV 300 mg / RTV n=40 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=33 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=48 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire Adherent at Week 24 (n=18, 11, 25)	10 participants	5 participants	23 participants
Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire Adherent at Baseline (n=27, 25, 33)	12 participants	10 participants	18 participants
Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire Adherent at Week 48 (n=11, 4, 20)	8 participants	2 participants	13 participants

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 48

Population: Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.

The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=110 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48) Baseline (n=99, 86, 100)	0.83 units on a scale Standard Error 0.02	0.85 units on a scale Standard Error 0.02	0.86 units on a scale Standard Error 0.02
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48) Mid-Study (n=103, 83, 95)	0.87 units on a scale Standard Error 0.02	0.86 units on a scale Standard Error 0.02	0.89 units on a scale Standard Error 0.01
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48) Final (n=93, 84, 96)	0.84 units on a scale Standard Error 0.02	0.85 units on a scale Standard Error 0.03	0.88 units on a scale Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 48

Population: Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.

The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=119 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=110 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV n=118 Participants LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48) Baseline (n=98, 85, 101)	81.33 units on a scale Standard Error 1.63	81.72 units on a scale Standard Error 1.77	81.52 units on a scale Standard Error 1.53
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48) Mid-Study (n=102, 83, 97)	84.89 units on a scale Standard Error 1.65	83.34 units on a scale Standard Error 1.89	85.09 units on a scale Standard Error 1.55
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48) Final (n=95, 81, 96)	82.77 units on a scale Standard Error 1.72	85.80 units on a scale Standard Error 1.64	86.16 units on a scale Standard Error 1.36

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 48

Population: Although the intent of this planned analysis was to provide a model of economic value for Lipid Management, a different approach was taken to create this model which did not require data from this trial, and thus this analysis was not done.

Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: collected at the pre-dose time point after receiving atazanavir for at least four weeks

Population: Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).

The minimum or "trough" concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=40 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=23 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values ATV (n=40,23)	719.53 ng/mL Standard Error 82.81	312.01 ng/mL Standard Error 145.31	—
Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values RTV (n=40,0)	154.83 ng/mL Standard Error 39.31	NA ng/mL Standard Error NA No participants were analyzed in this cohort for RTV because they did not take this drug.	—
Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values SQV (n=0,19)	NA ng/mL Standard Error NA No participants were analyzed in this cohort for SQV because they did not take this drug.	52.15 ng/mL Standard Error 16.89	—

SECONDARY outcome

Timeframe: Week 24

Population: Participants with evaluable IC50 measurements; as-randomized population (refers to the treatment regimen assigned at randomization).

IC50: inhibitory concentration of drug required to reduce viral replication by 50%.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=40 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=21 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
HIV IC50 at Week 24	17.83 ng/mL Standard Error 4.04	22.84 ng/mL Standard Error 11.65	—

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants with evaluable IQ measurements (ie, must have both Cmin and IC50 measurements); as-randomized population (refers to the treatment regimen assigned at randomization).

Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=40 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=21 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
Inhibitory Quotient at Week 24	136.94 ratio Standard Error 24.33	25.04 ratio Standard Error 13.33	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).

Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.

Outcome measures

Outcome measures
Measure	ATV 300 mg / RTV n=40 Participants ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	ATV 400 mg / SQV n=23 Participants ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study	LPV / RTV LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24 Baseline Values	4.53 log10 c/mL Standard Error 0.13	4.41 log10 c/mL Standard Error 0.13	—
HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24 Week 24 Values	2.62 log10 c/mL Standard Error 0.19	2.83 log10 c/mL Standard Error 0.25	—
HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24 Change from Baseline at Week 24	-1.91 log10 c/mL Standard Error 0.19	-1.57 log10 c/mL Standard Error 0.29	—

SECONDARY outcome

Timeframe: Baseline, Week 48

Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.

Outcome measures

Outcome data not reported

Adverse Events

ATV300/RTV

Serious events: 22 serious events

Other events: 101 other events

Deaths: 0 deaths

ATV400/SQV

Serious events: 22 serious events

Other events: 95 other events

Deaths: 0 deaths

LPV/RTV

Serious events: 19 serious events

Other events: 104 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

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