Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from 28 Sep 2007 through 23 Mar 2009 at 18 sites throughout the US. The sites were comprised of medical centers or private practice physicians.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a 28 day screening period where a genotype report was run. If patients were resistant to any of the study medication, they were not to be randomized into the study. Patients also needed to meet all inclusion/exclusion criteria in order to be eligible. 154 patients were enrolled but 2 were not treated, leaving 152 in full analysis set.

Reporting Groups

	Description
Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Participant Flow:   Overall Study

	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
STARTED	75 [1]	77 [1]
COMPLETED	51	59
NOT COMPLETED	24	18
Adverse Event	9	9
Protocol Violation	1	1
Lost to Follow-up	5	6
Withdrawal by Subject	2	2
Lack of Efficacy	6	0
not specified	1	0

Reporting Groups

	Description
Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Total	Total of all reporting groups

Baseline Measures

	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Total
Number of Participants   [units: participants]	75	77	152
Age   [units: years] Mean ± Standard Deviation	37.7  ± 10.4	35.9  ± 9.7	36.8  ± 10.1
Gender   [units: participants]
Female	10	6	16
Male	65	71	136
Log10 HIV viral load   [units: copies/mL] Mean ± Standard Deviation	4.9  ± 0.8	4.9  ± 0.7	4.9  ± 0.8
CD4+ count   [units: cells/mm^3] Mean ± Standard Deviation	178.9  ± 105.3	183.5  ± 111.3	181.2  ± 108.0

1.  Primary:

Number of Participants With Virologic Response (VR)   [ Time Frame: baseline to week 48 ]

2.  Secondary:

Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: baseline to week 48 ]

3.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48   [ Time Frame: baseline to week 48 ]

4.  Secondary:

Number of Participants With Virologic Success (FDA Definition)   [ Time Frame: baseline to week 48 ]

5.  Secondary:

Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants   [ Time Frame: baseline to week 48 ]

6.  Secondary:

Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml   [ Time Frame: baseline to week 48 ]

7.  Secondary:

Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response   [ Time Frame: baseline to week 48 ]

8.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment   [ Time Frame: baseline to week 2 ]

9.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment   [ Time Frame: baseline to week 4 ]

10.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment   [ Time Frame: baseline to week 6 ]

11.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment   [ Time Frame: baseline to week 8 ]

12.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment   [ Time Frame: baseline to week 12 ]

13.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment   [ Time Frame: baseline to week 24 ]

14.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment   [ Time Frame: baseline to week 36 ]

15.  Secondary:

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment   [ Time Frame: baseline to week 48 ]

16.  Secondary:

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment   [ Time Frame: baseline to week 2 ]

17.  Secondary:

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment   [ Time Frame: baseline to week 4 ]

18.  Secondary:

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment   [ Time Frame: baseline to week 6 ]

19.  Secondary:

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment   [ Time Frame: baseline to week 8 ]

20.  Secondary:

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment   [ Time Frame: baseline to week 12 ]

21.  Secondary:

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment   [ Time Frame: baseline to week 24 ]

22.  Secondary:

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment   [ Time Frame: baseline to week 36 ]

23.  Secondary:

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment   [ Time Frame: baseline to week 48 ]

24.  Secondary:

Number of Patients With Virologic Rebound to >400 Copies/ml   [ Time Frame: baseline to week 48 ]

25.  Secondary:

AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death   [ Time Frame: baseline to week 48 ]

26.  Secondary:

Change in CD4+ Cell Count From Baseline to Week 2.   [ Time Frame: baseline to week 2 ]

27.  Secondary:

Change in CD4+ Cell Count From Baseline to Week 4.   [ Time Frame: baseline to week 4 ]

28.  Secondary:

Change in CD4+ Cell Count From Baseline to Week 6.   [ Time Frame: baseline to week 6 ]

29.  Secondary:

Change in CD4+ Cell Count From Baseline to Week 8.   [ Time Frame: baseline to week 8 ]

30.  Secondary:

Change in CD4+ Cell Count From Baseline to Week 12.   [ Time Frame: baseline to week 12 ]

31.  Secondary:

Change in CD4+ Cell Count From Baseline to Week 24.   [ Time Frame: baseline to week 24 ]

32.  Secondary:

Change in CD4+ Cell Count From Baseline to Week 36.   [ Time Frame: baseline to week 36 ]

33.  Secondary:

Change in CD4+ Cell Count From Baseline to Week 48.   [ Time Frame: baseline to week 48 ]

34.  Secondary:

Change in Fasting Plasma Total Cholesterol Level   [ Time Frame: baseline to week 48 ]

35.  Secondary:

Change in Fasting Plasma Triglycerides Level   [ Time Frame: baseline to week 48 ]

36.  Secondary:

Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level   [ Time Frame: baseline to week 48 ]

37.  Secondary:

Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level   [ Time Frame: baseline to week 48 ]

38.  Secondary:

Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio   [ Time Frame: baseline to week 48 ]

39.  Secondary:

Change in Framingham Score   [ Time Frame: baseline to week 48 ]

40.  Secondary:

Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group   [ Time Frame: baseline to week 48 ]

41.  Secondary:

Change in Glomerular Filtration Rate (GFR)   [ Time Frame: baseline to week 48 ]

42.  Secondary:

Percentage Adherence by Pill Count   [ Time Frame: baseline to week 48 ]

43.  Secondary:

Number of Participants With Genotypic Resistance at the Time of Virologic Failure.   [ Time Frame: baseline to week 48 ]