Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups

	Description
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

Participant Flow:   Overall Study

	ATV 300 mg / RTV	ATV 400 mg / SQV	LPV / RTV
STARTED	119 [1]	110 [2]	118 [3]
Discontinued Prior to Week 48 Visit	26	29	13
Discontinued Between Weeks 48 and 96	26	27	30
Discontinued on or After Week 96	4	4	6
COMPLETED	63 [4]	50 [5]	69 [6]
NOT COMPLETED	56	60	49
Adverse Event	10	9	9
Death	0	0	1
Disease Progression / Relapse	1	1	0
Lost to Follow-up	4	4	3
Noncompliance	6	7	6
Protocol Violation While on Study	0	1	2
Withdrawal by Subject	1	5	0
Study Termination by Sponsor	1	0	0
Lack of Efficacy	33	33	28

Reporting Groups

	Description
ATV 300 mg / RTV	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	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

Baseline Measures

	ATV 300 mg / RTV	ATV 400 mg / SQV	LPV / RTV	Total
Number of Participants   [units: participants]	120	115	123	358
Age   [units: years] Median ( Full Range )	39     ( 24 to 71 )	41     ( 26 to 74 )	39     ( 25 to 72 )	40     ( 24 to 74 )
Gender   [units: participants]
Female	24	26	27	77
Male	96	89	96	281
Race/Ethnicity, Customized   [units: participants]
White	75	70	71	216
Hispanic/Latino	27	26	27	80
Black	18	16	21	55
Other	0	3	4	7
Region of Enrollment   [units: participants]
South America	56	55	54	165
North America	39	38	47	124
Europe	25	22	22	69
Acquired Immunodeficiency Virus (AIDS)   [units: participants]
Yes	33	33	36	102
No	87	82	87	256
Intravenous (IV) Drug Use   [units: participants]
Yes	8	7	8	23
No	112	108	115	335
Cluster of Differentiation 4 (CD4) cell count   [units: cells/mm^3] Median ( Full Range )	317     ( 40 to 1025 )	286     ( 42 to 1543 )	283     ( 14 to 1238 )	297     ( 14 to 1543 )
Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA)   [units: log10 c/mL] Median ( Full Range )	4.44     ( 2.60 to 5.88 )	4.42     ( 2.60 to 5.88 )	4.47     ( 2.60 to 5.88 )	4.45     ( 2.60 to 5.88 )

1.  Primary:

Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Primary:

Mean Change From Baseline in HIV RNA at Week 48   [ Time Frame: Baseline, Week 48 ]

3.  Primary:

Mean Change From Baseline in HIV RNA at Week 96   [ Time Frame: Baseline, Week 96 ]

4.  Secondary:

Mean Change From Baseline in HIV RNA at Week 2   [ Time Frame: Baseline, Week 2 ]

5.  Secondary:

Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)   [ Time Frame: Baseline, Week 24 ]

6.  Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)   [ Time Frame: Baseline, Week 48 ]

7.  Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96   [ Time Frame: Baseline, Week 96 ]

8.  Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24   [ Time Frame: Week 24 ]

9.  Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity   [ Time Frame: Baseline, Week 24 ]

10.  Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48   [ Time Frame: Week 48 ]

11.  Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity   [ Time Frame: Baseline, Week 48 ]

12.  Secondary:

Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96   [ Time Frame: Week 96 ]

13.  Secondary:

Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24   [ Time Frame: Week 24 ]

14.  Secondary:

Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48   [ Time Frame: Week 48 ]

15.  Secondary:

Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96   [ Time Frame: Week 96 ]

16.  Secondary:

Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24   [ Time Frame: Week 24 ]

17.  Secondary:

Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48   [ Time Frame: Week 48 ]

18.  Secondary:

Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96   [ Time Frame: Week 96 ]

19.  Secondary:

Change From Baseline in CD4 Cell Count at Week 24   [ Time Frame: Baseline, Week 24 ]

20.  Secondary:

Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline, Week 48 ]

21.  Secondary:

Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline, Week 96 ]

22.  Secondary:

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   [ Time Frame: Baseline, Week 24 ]

23.  Secondary:

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 48   [ Time Frame: Baseline, Week 48 ]

24.  Secondary:

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   [ Time Frame: Baseline, Week 24 ]

25.  Secondary:

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 48   [ Time Frame: Baseline, Week 48 ]

26.  Secondary:

Lipid Mean Percent Change From Baseline at Week 24   [ Time Frame: Baseline, Week 24 ]

27.  Secondary:

Lipid Mean Percent Change From Baseline at Week 48   [ Time Frame: Week 48 ]

28.  Secondary:

Lipid Mean Percent Change From Baseline at Week 96, Observed Values   [ Time Frame: Week 96 ]

29.  Secondary:

Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48   [ Time Frame: From Enrollment through Week 48 ]

30.  Secondary:

Most Common AEs and AEs of Interest Through Week 48   [ Time Frame: From Enrollment to Week 48 ]

31.  Secondary:

Fasting Glucose Mean Change From Baseline at Week 24   [ Time Frame: Baseline, Week 24 ]

32.  Secondary:

Fasting Glucose Mean Change From Baseline at Week 48   [ Time Frame: Week 48 ]

33.  Secondary:

Grade 3/4 Laboratory Abnormalities Through Week 48   [ Time Frame: From Enrollment to Week 48 ]

34.  Secondary:

Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point   [ Time Frame: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48 ]

35.  Secondary:

PR Interval and Change From Baseline by Analysis Time Point   [ Time Frame: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48 ]

36.  Secondary:

Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire   [ Time Frame: Baseline, Week 24, Week 48 ]

37.  Secondary:

Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)   [ Time Frame: Baseline, Week 24, Week 48 ]

38.  Secondary:

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)   [ Time Frame: Baseline, Week 24, Week 48 ]

39.  Secondary:

Number of Participants Utilizing Resources for Managing Lipid Elevation   [ Time Frame: Baseline, Week 24, Week 48 ]

40.  Secondary:

Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values   [ Time Frame: collected at the pre-dose time point after receiving atazanavir for at least four weeks ]

41.  Secondary:

HIV IC50 at Week 24   [ Time Frame: Week 24 ]

42.  Secondary:

Inhibitory Quotient at Week 24   [ Time Frame: Baseline, Week 24 ]

43.  Secondary:

Inhibitory Quotient at Week 48   [ Time Frame: Baseline, Week 48 ]

44.  Secondary:

HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24   [ Time Frame: Baseline, Week 24 ]

45.  Secondary:

HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48   [ Time Frame: Baseline, Week 48 ]