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

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ClinicalTrials.gov Identifier: NCT00552240
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : May 23, 2011
Last Update Posted : January 27, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: tenofovir DF 300 mg QD
Drug: emtricitabine 200 mg QD
Drug: Nevirapine 200 mg BID
Drug: Atazanavir 300 mg
Drug: Ritonavir 100 mg
Enrollment 154
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 Details 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
Hide 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 [1] 77 [1]
Completed 51 59
Not Completed 24 18
Reason Not Completed
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
[1]
Number in Full Analysis Set (FAS)
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Total
Hide 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 Number of Baseline Participants 75 77 152
Hide Baseline Analysis Population Description
Full Analysis Set (FAS)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 77 participants 152 participants
37.7  (10.4) 35.9  (9.7) 36.8  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 77 participants 152 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  
Mean (Standard Deviation)
Unit of measure:  copies/mL
Number Analyzed 75 participants 77 participants 152 participants
4.9  (0.8) 4.9  (0.7) 4.9  (0.8)
CD4+ count  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 75 participants 77 participants 152 participants
178.9  (105.3) 183.5  (111.3) 181.2  (108.0)
1.Primary Outcome
Title Number of Participants With Virologic Response (VR)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: participants
Responders 46 50
Nonresponders 29 27
Show Statistical Analysis 1 Hide 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 [Not Specified]
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
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
Responders 48 51
Nonresponders 27 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Same as for the primary analysis
Statistical Test of Hypothesis P-Value 0.6479
Comments [Not Specified]
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
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
Hide Description HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
Responders 42 48
Nonresponders 2 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Same as for primary analysis
Statistical Test of Hypothesis P-Value 0.1477
Comments [Not Specified]
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
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Virologic Success (FDA Definition)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients.
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
Responders 42 48
Nonresponders 33 29
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Same as for primary analysis
Statistical Test of Hypothesis P-Value 0.3703
Comments [Not Specified]
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
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Hide Description Time to response whereby patients withdrawing early were censored after their withdrawal
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Median (Inter-Quartile Range)
Unit of Measure: days
57
(42 to 168)
84
(56 to 173)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0314
Comments [Not Specified]
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
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
Hide Description [Not Specified]
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All responders
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 55 65
Median (Inter-Quartile Range)
Unit of Measure: days
55
(41 to 85)
84
(56 to 169)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0172
Comments [Not Specified]
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
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
At week 24 1 4
At week 48 2 9
8.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 50 copies/ml 6 5
HIV viral load ≥ 50 copies/ml 62 63
Missing data 7 9
9.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 50 copies/ml 12 10
HIV viral load ≥ 50 copies/ml 53 62
Missing data 10 5
10.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 50 copies/ml 23 14
HIV viral load ≥ 50 copies/ml 38 53
Missing data 14 10
11.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 50 copies/ml 34 23
HIV viral load ≥ 50 copies/ml 25 50
Missing data 16 4
12.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 50 copies/ml 42 43
HIV viral load ≥ 50 copies/ml 20 27
Missing data 13 7
13.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 50 copies/ml 48 61
HIV viral load ≥ 50 copies/ml 9 5
Missing data 18 11
14.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 50 copies/ml 53 55
HIV viral load ≥ 50 copies/ml 4 5
Missing data 18 17
15.Secondary Outcome
Title Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 50 copies/ml 42 48
HIV viral load ≥ 50 copies/ml 2 8
Missing data 31 21
16.Secondary Outcome
Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 400 copies/ml 24 17
HIV viral load ≥ 400 copies/ml 44 51
Missing data 7 9
17.Secondary Outcome
Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 400 copies/ml 38 31
HIV viral load ≥ 400 copies/ml 27 41
Missing data 10 5
18.Secondary Outcome
Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 400 copies/ml 40 44
HIV viral load ≥ 400 copies/ml 21 23
Missing data 14 10
19.Secondary Outcome
Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 400 copies/ml 48 58
HIV viral load ≥ 400 copies/ml 11 15
Missing data 16 4
20.Secondary Outcome
Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 400 copies/ml 56 63
HIV viral load ≥ 400 copies/ml 6 7
Missing data 13 7
21.Secondary Outcome
Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 400 copies/ml 51 63
HIV viral load ≥ 400 copies/ml 6 3
Missing data 18 11
22.Secondary Outcome
Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 400 copies/ml 54 59
HIV viral load ≥ 400 copies/ml 3 1
Missing data 18 17
23.Secondary Outcome
Title Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Hide Description Results within time windows, patients on-treatment
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
HIV viral load < 400 copies/ml 43 54
HIV viral load ≥ 400 copies/ml 1 2
Missing data 31 21
24.Secondary Outcome
Title Number of Patients With Virologic Rebound to >400 Copies/ml
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
Rebound following response 2 6
No rebound following response 55 63
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: Participants
1 3
26.Secondary Outcome
Title Change in CD4+ Cell Count From Baseline to Week 2.
Hide Description Patients on-treatment, data within time windows
Time Frame baseline to week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 64 64
Mean (Standard Deviation)
Unit of Measure: 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.
Hide Description Patients on-treatment, data within time windows
Time Frame baseline to week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 65 70
Mean (Standard Deviation)
Unit of Measure: 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.
Hide Description Patients on-treatment, data within time windows
Time Frame baseline to week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 59 62
Mean (Standard Deviation)
Unit of Measure: 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.
Hide Description Patients on-treatment, data within time windows
Time Frame baseline to week 8
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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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 58 69
Mean (Standard Deviation)
Unit of Measure: 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.
Hide Description Patients on-treatment, data within time windows
Time Frame baseline to week 12
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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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 62 68
Mean (Standard Deviation)
Unit of Measure: 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.
Hide Description Patients on-treatment, data within time windows
Time Frame baseline to week 24
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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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 59 68
Mean (Standard Deviation)
Unit of Measure: 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.
Hide Description Patients on-treatment, data within time windows
Time Frame baseline to week 36
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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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 57 61
Mean (Standard Deviation)
Unit of Measure: 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.
Hide Description Patients on-treatment, data within time windows
Time Frame baseline to week 48
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Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 46 54
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
155.1  (118.8) 160.4  (108.7)
34.Secondary Outcome
Title Change in Fasting Plasma Total Cholesterol Level
Hide Description [Not Specified]
Time Frame baseline to week 48
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Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: mg/dl
18.2  (26.5) 13.8  (39.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7315
Comments [Not Specified]
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
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Change in Fasting Plasma Triglycerides Level
Hide Description [Not Specified]
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: mg/dl
-4.7  (87.6) 8.4  (120.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3625
Comments [Not Specified]
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
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
Hide Description [Not Specified]
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: mg/dl
9.6  (11.8) 3.5  (15.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0164
Comments [Not Specified]
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
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
Hide Description [Not Specified]
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: mg/dl
8.7  (21.5) 6.9  (32.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9257
Comments [Not Specified]
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
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
Hide Description [Not Specified]
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: ratio
-0.38  (0.96) -0.02  (1.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0375
Comments [Not Specified]
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
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Change in Framingham Score
Hide 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
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All treated patients with data, Last observation carried forward (LOCF)
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 67 71
Mean (Standard Deviation)
Unit of Measure: percent 10-year risk
-0.09  (2.01) 0.14  (2.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nevirapine (NVP) Plus Truvada, Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4645
Comments [Not Specified]
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
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
Hide Description [Not Specified]
Time Frame baseline to week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
41.Secondary Outcome
Title Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
Hide Description using 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time Frame baseline to week 48
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Hide 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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 66 68
Mean (Standard Deviation)
Unit of Measure: ml/min/1.73m^2
-0.06  (33.90) -12.81  (35.61)
42.Secondary Outcome
Title Percentage Adherence by Pill Count
Hide Description Number of pills not returned / number of treatment days in percent (%)
Time Frame baseline to week 48
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All treated patients with data
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 71 76
Mean (Standard Deviation)
Unit of Measure: 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.
Hide 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
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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
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
44.Secondary Outcome
Title Incidence of Patients With AIDS Progression at Each Visit
Hide Description Cumulative incidence of patients with AIDS progression are shown
Time Frame baseline to week 52
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Full Analysis set
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: participants
week 0 0 0
week 2 0 0
week 4 0 0
week 6 0 1
week 8 0 1
week 12 0 2
week 24 0 3
week 36 0 3
week 48 1 3
week 50 1 3
End of Study Visit 2 3
45.Secondary Outcome
Title Proportion of Patients Reporting CNS Side Effects of Any Severity
Hide Description [Not Specified]
Time Frame baseline to week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: participants
25 23
46.Secondary Outcome
Title Proportion of Patients Reporting Hepatic Events of Any Severity
Hide Description [Not Specified]
Time Frame baseline to week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: participants
5 24
47.Secondary Outcome
Title Proportion of Patients Reporting Rash of Any Severity
Hide Description [Not Specified]
Time Frame baseline to week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: participants
21 19
48.Secondary Outcome
Title Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Hide Description [Not Specified]
Time Frame baseline to week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide Arm/Group Description:
Nevirapine 200 mg bis in die (BID)
Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
Overall Number of Participants Analyzed 75 77
Measure Type: Number
Unit of Measure: participants
Grade 2 moderate 25 31
Grade 3 severe 8 7
Grade 4 potential lifethreatening 7 3
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Affected / at Risk (%) Affected / at Risk (%)
Total   10/75 (13.33%)   7/77 (9.09%) 
Cardiac disorders     
Pericardial effusion  1  0/75 (0.00%)  1/77 (1.30%) 
Hepatobiliary disorders     
Hepatitis  1  1/75 (1.33%)  0/77 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  1/75 (1.33%)  0/77 (0.00%) 
Immune reconstitution syndrome  1  1/75 (1.33%)  0/77 (0.00%) 
Infections and infestations     
Bronchopneumonia  1  1/75 (1.33%)  0/77 (0.00%) 
Cerebral toxoplasmosis  1  1/75 (1.33%)  0/77 (0.00%) 
Gastroenteritis viral  1  1/75 (1.33%)  0/77 (0.00%) 
Injury, poisoning and procedural complications     
Epicondylitis  1  0/75 (0.00%)  1/77 (1.30%) 
Overdose  1  0/75 (0.00%)  1/77 (1.30%) 
Thermal burn  1  1/75 (1.33%)  0/77 (0.00%) 
Rib fracture  1  0/75 (0.00%)  1/77 (1.30%) 
Upper limb fracture  1  0/75 (0.00%)  1/77 (1.30%) 
Investigations     
Transaminases increased  1  1/75 (1.33%)  0/77 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/75 (0.00%)  1/77 (1.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Burkitt’s lymphoma  1  0/75 (0.00%)  1/77 (1.30%) 
Nervous system disorders     
Cerebrovascular accident  1  0/75 (0.00%)  1/77 (1.30%) 
Mononeuropathy multiplex  1  1/75 (1.33%)  0/77 (0.00%) 
Dizziness  1  1/75 (1.33%)  0/77 (0.00%) 
Hypoaesthesia  1  1/75 (1.33%)  0/77 (0.00%) 
Psychiatric disorders     
Suicidal ideation  1  1/75 (1.33%)  2/77 (2.60%) 
Suicide attempt  1  0/75 (0.00%)  2/77 (2.60%) 
Completed suicide  1  1/75 (1.33%)  0/77 (0.00%) 
Depression  1  0/75 (0.00%)  1/77 (1.30%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/75 (1.33%)  1/77 (1.30%) 
Pleural effusion  1  0/75 (0.00%)  1/77 (1.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nevirapine (NVP) Plus Truvada Atazanavir Plus Ritonavir (ATV/r) Plus Truvada
Affected / at Risk (%) Affected / at Risk (%)
Total   50/75 (66.67%)   61/77 (79.22%) 
Eye disorders     
Ocular icterus  1  1/75 (1.33%)  11/77 (14.29%) 
Gastrointestinal disorders     
Diarrhoea  1  12/75 (16.00%)  15/77 (19.48%) 
Nausea  1  10/75 (13.33%)  11/77 (14.29%) 
Vomiting  1  3/75 (4.00%)  6/77 (7.79%) 
Gastritis  1  0/75 (0.00%)  4/77 (5.19%) 
General disorders     
Fatigue  1  13/75 (17.33%)  10/77 (12.99%) 
Oedema peripheral  1  2/75 (2.67%)  4/77 (5.19%) 
Hepatobiliary disorders     
Jaundice  1  0/75 (0.00%)  12/77 (15.58%) 
Infections and infestations     
Upper respiratory tract infection  1  8/75 (10.67%)  18/77 (23.38%) 
Sinusitis  1  3/75 (4.00%)  7/77 (9.09%) 
Anogenital warts  1  1/75 (1.33%)  6/77 (7.79%) 
Bronchitis  1  2/75 (2.67%)  5/77 (6.49%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  6/75 (8.00%)  3/77 (3.90%) 
Nervous system disorders     
Headache  1  11/75 (14.67%)  11/77 (14.29%) 
Dizziness  1  4/75 (5.33%)  5/77 (6.49%) 
Psychiatric disorders     
Insomnia  1  4/75 (5.33%)  7/77 (9.09%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/75 (9.33%)  8/77 (10.39%) 
Oropharyngeal pain  1  5/75 (6.67%)  1/77 (1.30%) 
Skin and subcutaneous tissue disorders     
Rash  1  7/75 (9.33%)  3/77 (3.90%) 
Acne  1  1/75 (1.33%)  6/77 (7.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00552240     History of Changes
Other Study ID Numbers: 1100.1512
First Submitted: September 28, 2007
First Posted: November 1, 2007
Results First Submitted: March 16, 2011
Results First Posted: May 23, 2011
Last Update Posted: January 27, 2014