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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00552240
• Collaborator: (none)
• Enrollment: 154
• Locations: 19
• Arms: 2
• Patients Per Site: 8.1

Study Details

Study Description

Brief Summary

The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: tenofovir DF 300 mg QD; Drug: tenofovir DF 300 mg QD; Drug: emtricitabine 200 mg QD; Drug: emtricitabine 200 mg QD; Drug: Nevirapine 200 mg BID; Drug: Atazanavir 300 mg; Drug: Ritonavir 100 mg	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison Atazanavir/Ritonavir (ATV/r) vs Nevirapine (NVP) Twice a Day (Bid) on Truvada Backbone
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NVP 200mg bis indie (BID) after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks	Drug: tenofovir DF 300 mg QD; 300 mg QD; Drug: emtricitabine 200 mg QD; 200 mg QD; Drug: Nevirapine 200 mg BID; 200 mg BID
Active Comparator: Atazanavir 300 mg QD/ritonavir 100 mg QD patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks	Drug: tenofovir DF 300 mg QD; 300 mg QD; Drug: emtricitabine 200 mg QD; 200 mg QD; Drug: Atazanavir 300 mg; 300 mg QD; Drug: Ritonavir 100 mg; 100 mg QD

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Virologic Response (VR) [baseline to week 48]

   VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.

Secondary Outcome Measures

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

   HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.

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

   HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.

3. Number of Participants With Virologic Success (FDA Definition) [baseline to week 48]

   HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).

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

   Time to response whereby patients withdrawing early were censored after their withdrawal

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

6. Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response [baseline to week 24 and week 48]

   HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)

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

   Results within time windows, patients on-treatment

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

   Results within time windows, patients on-treatment

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

   Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

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

    Results within time windows, patients on-treatment

23. Number of Patients With Virologic Rebound to >400 Copies/ml [baseline to week 48]

    HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)

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

    AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting. Number of cases (no time-to analysis was performed due to small numbers).

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

    Patients on-treatment, data within time windows

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

    Patients on-treatment, data within time windows

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

    Patients on-treatment, data within time windows

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

    Patients on-treatment, data within time windows

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

    Patients on-treatment, data within time windows

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

    Patients on-treatment, data within time windows

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

    Patients on-treatment, data within time windows

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

    Patients on-treatment, data within time windows

33. Change in Fasting Plasma Total Cholesterol Level [baseline to week 48]

34. Change in Fasting Plasma Triglycerides Level [baseline to week 48]

35. Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level [baseline to week 48]

36. Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level [baseline to week 48]

37. Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio [baseline to week 48]

38. Change in Framingham Score [baseline to week 48]

    Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.

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

40. Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48 [baseline to week 48]

    using 4-variable Modification of Diet in Renal Disease (MDRD) formula

41. Percentage Adherence by Pill Count [baseline to week 48]

    Number of pills not returned / number of treatment days in percent (%)

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

    Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.

43. Incidence of Patients With AIDS Progression at Each Visit [baseline to week 52]

    Cumulative incidence of patients with AIDS progression are shown

44. Proportion of Patients Reporting CNS Side Effects of Any Severity [baseline to week 52]

45. Proportion of Patients Reporting Hepatic Events of Any Severity [baseline to week 52]

46. Proportion of Patients Reporting Rash of Any Severity [baseline to week 52]

47. Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities [baseline to week 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation

2. HIV-1- infected males or females greater than or equal to 18 years of age with documented positive serology Enzyme-linked Immuno Sorbert Assay (ELISA) confirmed by Western blot

3. No prior nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) use of more than 10 days AND

4. No prior use of other classes of antiretrovirals (ARVs) of more than 2 weeks duration

5. Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed

6. NVP and ATV/r susceptibility on screening HIV-1 genotypic resistance assay

7. Adequate renal function defined as a calculated creatinine clearance greater than or equal to50 ml/min according to the Cockcroft-Gault formula

8. Karnofsky score greater than or equal to 70 (see Appendix 10.7)

9. Acceptable medical history, as assessed by the investigator

Exclusion criteria:

1. History of active drug or alcohol abuse within 2 years prior to study entry (at the investigators discretion)

2. Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment

3. Female patients of child-bearing potential who:

have a positive serum pregnancy test at screening, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives

1. Laboratory parameters greater than Division of Aids (National Institute of Health, USA) (DAIDS) grade 2 (triglycerides greater than DAIDS grade 3, total cholesterol no restrictions, see Appendix 10.1)

2. Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C Virus (HCV) RNA positive with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ALT/AST greater than2.5x Upper Limit of Normal (ULN) (greater than DAIDS grade 1)

3. Known hypersensitivity to any ingredients in nevirapine or atazanavir

4. Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6

5. Use of other investigational medications within 30 days before study entry or during the trial

6. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone)

7. Patients with Progressive Multifocal Leukoencephalopathy (PML), visceral Kaposi's Sarcoma (KS), and/or any lymphoma

8. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at the screening visit

9. Patients who are receiving systemic chemotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1100.1512.28 Boehringer Ingelheim Investigational Site	Beverly Hills	California	United States
2	1100.1512.20 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
3	1100.1512.15 Boehringer Ingelheim Investigational Site	Denver	Colorado	United States
4	1100.1512.26 Boehringer Ingelheim Investigational Site	Washington	District of Columbia	United States
5	1100.1512.17 Boehringer Ingelheim Investigational Site	Fort Lauderdale	Florida	United States
6	1100.1512.14 Boehringer Ingelheim Investigational Site	Orlando	Florida	United States
7	1100.1512.23 Boehringer Ingelheim Investigational Site	Vero Beach	Florida	United States
8	1100.1512.29 Boehringer Ingelheim Investigational Site	Maywood	Illinois	United States
9	1100.1512.11 Boehringer Ingelheim Investigational Site	Neptune	New Jersey	United States
10	1100.1512.25 Boehringer Ingelheim Investigational Site	Newark	New Jersey	United States
11	1100.1512.18 Boehringer Ingelheim Investigational Site	Somers Point	New Jersey	United States
12	1100.1512.22 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina	United States
13	1100.1512.21 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania	United States
14	1100.1512.13 Boehringer Ingelheim Investigational Site	Charleston	South Carolina	United States
15	1100.1512.30 Boehringer Ingelheim Investigational Site	Dallas	Texas	United States
16	1100.1512.19 Boehringer Ingelheim Investigational Site	Fort Worth	Texas	United States
17	1100.1512.16 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
18	1100.1512.24 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
19	1100.1512.27 Boehringer Ingelheim Investigational Site	Annandale	Virginia	United States

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00552240
• Other Study ID Numbers: 1100.1512
• First Posted: Nov 1, 2007
• Last Update Posted: Jan 27, 2014
• Last Verified: Dec 1, 2013

• Additional relevant MeSH terms: HIV Infections; Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine; Nevirapine

Study Results

Participant Flow

Recruitment Details	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 Detail	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.

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Period Title: Overall Study
STARTED	75	77
COMPLETED	51	59
NOT COMPLETED	24	18

Baseline Characteristics

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Total
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)	Total of all reporting groups
Overall Participants	75	77	152
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.7 (10.4)	35.9 (9.7)	36.8 (10.1)
Sex: Female, Male (Count of Participants)
Female	10 13.3%	6 7.8%	16 10.5%
Male	65 86.7%	71 92.2%	136 89.5%
Log10 HIV viral load (copies/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [copies/mL]	4.9 (0.8)	4.9 (0.7)	4.9 (0.8)
CD4+ count (cells/mm^3) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/mm^3]	178.9 (105.3)	183.5 (111.3)	181.2 (108.0)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Virologic Response (VR)
Description	VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48.
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients. Early withdrawals were considered failures.

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Responders	46 61.3%	50 64.9%
Nonresponders	29 38.7%	27 35.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments	With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).
Statistical Test of Hypothesis	p-Value	0.7142
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Difference in proportion of responders
	Estimated Value	-0.041
	Confidence Interval	() 95%; -0.183 to 0.101
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
Description	HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48.
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients. Early withdrawals were considered failures.

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Responders	48 64%	51 66.2%
Nonresponders	27 36%	26 33.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Same as for the primary analysis
Statistical Test of Hypothesis	p-Value	0.6479
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Difference in proportion of responders
	Estimated Value	-0.027
	Confidence Interval	() 95%; -0.167 to 0.113
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
Description	HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

Only includes treated patients with data in the Week 48 time window.

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Responders	42 56%	48 62.3%
Nonresponders	2 2.7%	8 10.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Same as for primary analysis
Statistical Test of Hypothesis	p-Value	0.1477
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Difference in proportion of responders
	Estimated Value	0.084
	Confidence Interval	() 95%; -0.030 to 0.197
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Participants With Virologic Success (FDA Definition)
Description	HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS).
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients.

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Responders	42 56%	48 62.3%
Nonresponders	33 44%	29 37.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Same as for primary analysis
Statistical Test of Hypothesis	p-Value	0.3703
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Difference in proportion of responders
	Estimated Value	-0.067
	Confidence Interval	() 95%; -0.215 to 0.080
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Description	Time to response whereby patients withdrawing early were censored after their withdrawal
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Median (Inter-Quartile Range) [days]	57	84

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments	Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values < 1 indicate faster response in nevirapine.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0314
	Comments
	Method	Regression, Cox
	Comments	Controlling for screening viral load and CD4+ categories.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.666
	Confidence Interval	() 95%; 0.460 to 0.964
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

All responders

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	55	65
Median (Inter-Quartile Range) [days]	55	84

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments	Responders only Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values < 1 indicate faster response in nevirapine.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0172
	Comments
	Method	Regression, Cox
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.628
	Confidence Interval	() 95%; 0.428 to 0.921
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
Description	HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Time Frame	baseline to week 24 and week 48

Outcome Measure Data

Analysis Population Description

All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
At week 24	1 1.3%	4 5.2%
At week 48	2 2.7%	9 11.7%

8. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 2

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 50 copies/ml	6 8%	5 6.5%
HIV viral load ≥ 50 copies/ml	62 82.7%	63 81.8%
Missing data	7 9.3%	9 11.7%

9. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 4

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 50 copies/ml	12 16%	10 13%
HIV viral load ≥ 50 copies/ml	53 70.7%	62 80.5%
Missing data	10 13.3%	5 6.5%

10. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 6

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 50 copies/ml	23 30.7%	14 18.2%
HIV viral load ≥ 50 copies/ml	38 50.7%	53 68.8%
Missing data	14 18.7%	10 13%

11. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 8

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 50 copies/ml	34 45.3%	23 29.9%
HIV viral load ≥ 50 copies/ml	25 33.3%	50 64.9%
Missing data	16 21.3%	4 5.2%

12. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 12

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 50 copies/ml	42 56%	43 55.8%
HIV viral load ≥ 50 copies/ml	20 26.7%	27 35.1%
Missing data	13 17.3%	7 9.1%

13. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 24

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 50 copies/ml	48 64%	61 79.2%
HIV viral load ≥ 50 copies/ml	9 12%	5 6.5%
Missing data	18 24%	11 14.3%

14. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 36

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 50 copies/ml	53 70.7%	55 71.4%
HIV viral load ≥ 50 copies/ml	4 5.3%	5 6.5%
Missing data	18 24%	17 22.1%

15. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 50 copies/ml	42 56%	48 62.3%
HIV viral load ≥ 50 copies/ml	2 2.7%	8 10.4%
Missing data	31 41.3%	21 27.3%

16. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 2

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 400 copies/ml	24 32%	17 22.1%
HIV viral load ≥ 400 copies/ml	44 58.7%	51 66.2%
Missing data	7 9.3%	9 11.7%

17. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 4

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 400 copies/ml	38 50.7%	31 40.3%
HIV viral load ≥ 400 copies/ml	27 36%	41 53.2%
Missing data	10 13.3%	5 6.5%

18. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 6

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 400 copies/ml	40 53.3%	44 57.1%
HIV viral load ≥ 400 copies/ml	21 28%	23 29.9%
Missing data	14 18.7%	10 13%

19. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 8

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 400 copies/ml	48 64%	58 75.3%
HIV viral load ≥ 400 copies/ml	11 14.7%	15 19.5%
Missing data	16 21.3%	4 5.2%

20. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 12

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 400 copies/ml	56 74.7%	63 81.8%
HIV viral load ≥ 400 copies/ml	6 8%	7 9.1%
Missing data	13 17.3%	7 9.1%

21. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 24

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 400 copies/ml	51 68%	63 81.8%
HIV viral load ≥ 400 copies/ml	6 8%	3 3.9%
Missing data	18 24%	11 14.3%

22. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 36

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 400 copies/ml	54 72%	59 76.6%
HIV viral load ≥ 400 copies/ml	3 4%	1 1.3%
Missing data	18 24%	17 22.1%

23. Secondary Outcome

Title	Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Description	Results within time windows, patients on-treatment
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
HIV viral load < 400 copies/ml	43 57.3%	54 70.1%
HIV viral load ≥ 400 copies/ml	1 1.3%	2 2.6%
Missing data	31 41.3%	21 27.3%

24. Secondary Outcome

Title	Number of Patients With Virologic Rebound to >400 Copies/ml
Description	HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml)
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Rebound following response	2 2.7%	6 7.8%
No rebound following response	55 73.3%	63 81.8%

25. Secondary Outcome

Title	AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
Description	AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting. Number of cases (no time-to analysis was performed due to small numbers).
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Number [Participants]	1 1.3%	3 3.9%

26. Secondary Outcome

Title	Change in CD4+ Cell Count From Baseline to Week 2.
Description	Patients on-treatment, data within time windows
Time Frame	baseline to week 2

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	64	64
Mean (Standard Deviation) [cells/mm^3]	62.6 (80.9)	61.0 (69.7)

27. Secondary Outcome

Title	Change in CD4+ Cell Count From Baseline to Week 4.
Description	Patients on-treatment, data within time windows
Time Frame	baseline to week 4

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	65	70
Mean (Standard Deviation) [cells/mm^3]	76.4 (88.2)	63.0 (72.6)

28. Secondary Outcome

Title	Change in CD4+ Cell Count From Baseline to Week 6.
Description	Patients on-treatment, data within time windows
Time Frame	baseline to week 6

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	59	62
Mean (Standard Deviation) [cells/mm^3]	87.2 (86.0)	78.4 (67.6)

29. Secondary Outcome

Title	Change in CD4+ Cell Count From Baseline to Week 8.
Description	Patients on-treatment, data within time windows
Time Frame	baseline to week 8

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	58	69
Mean (Standard Deviation) [cells/mm^3]	111.9 (100.2)	90.5 (85.2)

30. Secondary Outcome

Title	Change in CD4+ Cell Count From Baseline to Week 12.
Description	Patients on-treatment, data within time windows
Time Frame	baseline to week 12

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	62	68
Mean (Standard Deviation) [cells/mm^3]	123.1 (109.5)	102.2 (103.9)

31. Secondary Outcome

Title	Change in CD4+ Cell Count From Baseline to Week 24.
Description	Patients on-treatment, data within time windows
Time Frame	baseline to week 24

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	59	68
Mean (Standard Deviation) [cells/mm^3]	131.8 (115.5)	132.5 (86.8)

32. Secondary Outcome

Title	Change in CD4+ Cell Count From Baseline to Week 36.
Description	Patients on-treatment, data within time windows
Time Frame	baseline to week 36

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	57	61
Mean (Standard Deviation) [cells/mm^3]	147.6 (120.7)	120.5 (99.4)

33. Secondary Outcome

Title	Change in CD4+ Cell Count From Baseline to Week 48.
Description	Patients on-treatment, data within time windows
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	46	54
Mean (Standard Deviation) [cells/mm^3]	155.1 (118.8)	160.4 (108.7)

34. Secondary Outcome

Title	Change in Fasting Plasma Total Cholesterol Level
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients with data, Last observation carried forward (LOCF).

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	66	68
Mean (Standard Deviation) [mg/dl]	18.2 (26.5)	13.8 (39.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7315
	Comments
	Method	ANCOVA
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	1.8
	Confidence Interval	() 95%; -8.4 to 11.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

35. Secondary Outcome

Title	Change in Fasting Plasma Triglycerides Level
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients with data, Last observation carried forward (LOCF)

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	66	68
Mean (Standard Deviation) [mg/dl]	-4.7 (87.6)	8.4 (120.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3625
	Comments
	Method	ANCOVA
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-10.6
	Confidence Interval	() 95%; -33.4 to 12.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

36. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All treated patients with data, Last observation carried forward (LOCF)

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	66	68
Mean (Standard Deviation) [mg/dl]	9.6 (11.8)	3.5 (15.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0164
	Comments
	Method	ANCOVA
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.8
	Confidence Interval	() 95%; 0.9 to 8.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

37. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All treated patients with data, Last observation carried forward (LOCF)

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	66	68
Mean (Standard Deviation) [mg/dl]	8.7 (21.5)	6.9 (32.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9257
	Comments
	Method	ANCOVA
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.4
	Confidence Interval	() 95%; -8.4 to 9.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

38. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All treated patients with data, Last observation carried forward (LOCF)

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	66	68
Mean (Standard Deviation) [ratio]	-0.38 (0.96)	-0.02 (1.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0375
	Comments
	Method	ANCOVA
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.33
	Confidence Interval	() 95%; -0.64 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

39. Secondary Outcome

Title	Change in Framingham Score
Description	Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients with data, Last observation carried forward (LOCF)

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	67	71
Mean (Standard Deviation) [percent 10-year risk]	-0.09 (2.01)	0.14 (2.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4645
	Comments
	Method	ANCOVA
	Comments	Controlling for screening viral load and CD4+ categories
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.28
	Confidence Interval	() 95%; -1.02 to 0.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

40. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Not calculated as no data on family history of cardiovascular disease were available

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	0	0

41. Secondary Outcome

Title	Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
Description	using 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data for the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	66	68
Mean (Standard Deviation) [ml/min/1.73m^2]	-0.06 (33.90)	-12.81 (35.61)

42. Secondary Outcome

Title	Percentage Adherence by Pill Count
Description	Number of pills not returned / number of treatment days in percent (%)
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

All treated patients with data

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	71	76
Mean (Standard Deviation) [percentage adherence]	94.3 (17.7)	97.0 (8.1)

43. Secondary Outcome

Title	Number of Participants With Genotypic Resistance at the Time of Virologic Failure.
Description	Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.
Time Frame	baseline to week 48

Outcome Measure Data

Analysis Population Description

Includes only treated patients with data in the specified time window

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	0	0

44. Secondary Outcome

Title	Incidence of Patients With AIDS Progression at Each Visit
Description	Cumulative incidence of patients with AIDS progression are shown
Time Frame	baseline to week 52

Outcome Measure Data

Analysis Population Description

Full Analysis set

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
week 0	0 0%	0 0%
week 2	0 0%	0 0%
week 4	0 0%	0 0%
week 6	0 0%	1 1.3%
week 8	0 0%	1 1.3%
week 12	0 0%	2 2.6%
week 24	0 0%	3 3.9%
week 36	0 0%	3 3.9%
week 48	1 1.3%	3 3.9%
week 50	1 1.3%	3 3.9%
End of Study Visit	2 2.7%	3 3.9%

45. Secondary Outcome

Title	Proportion of Patients Reporting CNS Side Effects of Any Severity
Time Frame	baseline to week 52

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Number [participants]	25 33.3%	23 29.9%

46. Secondary Outcome

Title	Proportion of Patients Reporting Hepatic Events of Any Severity
Time Frame	baseline to week 52

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Number [participants]	5 6.7%	24 31.2%

47. Secondary Outcome

Title	Proportion of Patients Reporting Rash of Any Severity
Time Frame	baseline to week 52

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Number [participants]	21 28%	19 24.7%

48. Secondary Outcome

Title	Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Time Frame	baseline to week 52

Outcome Measure Data

Analysis Population Description

All treated patients

Arm/Group Title	Nevirapine (NVP) Plus Truvada	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Measure Participants	75	77
Grade 2 moderate	25 33.3%	31 40.3%
Grade 3 severe	8 10.7%	7 9.1%
Grade 4 potential lifethreatening	7 9.3%	3 3.9%

Adverse Events

Time Frame	52 weeks
Arm/Group Title	Nevirapine (NVP) Plus Truvada		Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Arm/Group Description	Nevirapine 200 mg bis in die (BID)		Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
All Cause Mortality
	Nevirapine (NVP) Plus Truvada		Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Nevirapine (NVP) Plus Truvada		Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/75 (13.3%)		7/77 (9.1%)
Cardiac disorders
Pericardial effusion	0/75 (0%)		1/77 (1.3%)
Hepatobiliary disorders
Hepatitis	1/75 (1.3%)		0/77 (0%)
Immune system disorders
Drug hypersensitivity	1/75 (1.3%)		0/77 (0%)
Immune reconstitution syndrome	1/75 (1.3%)		0/77 (0%)
Infections and infestations
Bronchopneumonia	1/75 (1.3%)		0/77 (0%)
Cerebral toxoplasmosis	1/75 (1.3%)		0/77 (0%)
Gastroenteritis viral	1/75 (1.3%)		0/77 (0%)
Injury, poisoning and procedural complications
Epicondylitis	0/75 (0%)		1/77 (1.3%)
Overdose	0/75 (0%)		1/77 (1.3%)
Thermal burn	1/75 (1.3%)		0/77 (0%)
Rib fracture	0/75 (0%)		1/77 (1.3%)
Upper limb fracture	0/75 (0%)		1/77 (1.3%)
Investigations
Transaminases increased	1/75 (1.3%)		0/77 (0%)
Metabolism and nutrition disorders
Dehydration	0/75 (0%)		1/77 (1.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma	0/75 (0%)		1/77 (1.3%)
Nervous system disorders
Cerebrovascular accident	0/75 (0%)		1/77 (1.3%)
Mononeuropathy multiplex	1/75 (1.3%)		0/77 (0%)
Dizziness	1/75 (1.3%)		0/77 (0%)
Hypoaesthesia	1/75 (1.3%)		0/77 (0%)
Psychiatric disorders
Suicidal ideation	1/75 (1.3%)		2/77 (2.6%)
Suicide attempt	0/75 (0%)		2/77 (2.6%)
Completed suicide	1/75 (1.3%)		0/77 (0%)
Depression	0/75 (0%)		1/77 (1.3%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/75 (1.3%)		1/77 (1.3%)
Pleural effusion	0/75 (0%)		1/77 (1.3%)
Other (Not Including Serious) Adverse Events
	Nevirapine (NVP) Plus Truvada		Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	50/75 (66.7%)		61/77 (79.2%)
Eye disorders
Ocular icterus	1/75 (1.3%)		11/77 (14.3%)
Gastrointestinal disorders
Diarrhoea	12/75 (16%)		15/77 (19.5%)
Nausea	10/75 (13.3%)		11/77 (14.3%)
Vomiting	3/75 (4%)		6/77 (7.8%)
Gastritis	0/75 (0%)		4/77 (5.2%)
General disorders
Fatigue	13/75 (17.3%)		10/77 (13%)
Oedema peripheral	2/75 (2.7%)		4/77 (5.2%)
Hepatobiliary disorders
Jaundice	0/75 (0%)		12/77 (15.6%)
Infections and infestations
Upper respiratory tract infection	8/75 (10.7%)		18/77 (23.4%)
Sinusitis	3/75 (4%)		7/77 (9.1%)
Anogenital warts	1/75 (1.3%)		6/77 (7.8%)
Bronchitis	2/75 (2.7%)		5/77 (6.5%)
Musculoskeletal and connective tissue disorders
Back pain	6/75 (8%)		3/77 (3.9%)
Nervous system disorders
Headache	11/75 (14.7%)		11/77 (14.3%)
Dizziness	4/75 (5.3%)		5/77 (6.5%)
Psychiatric disorders
Insomnia	4/75 (5.3%)		7/77 (9.1%)
Respiratory, thoracic and mediastinal disorders
Cough	7/75 (9.3%)		8/77 (10.4%)
Oropharyngeal pain	5/75 (6.7%)		1/77 (1.3%)
Skin and subcutaneous tissue disorders
Rash	7/75 (9.3%)		3/77 (3.9%)
Acne	1/75 (1.3%)		6/77 (7.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.