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

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

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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
Total	Total of all reporting groups

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 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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