HIV Infections
Conditions
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).
Interventions
300 mg QD
DRUGemtricitabine 200 mg QD
200 mg QD
DRUGNevirapine 200 mg BID
200 mg BID
300 mg QD
DRUGRitonavir 100 mg
100 mg QD
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 4. 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) 5. 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) 6. Known hypersensitivity to any ingredients in nevirapine or atazanavir 7. Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6 8. Use of other investigational medications within 30 days before study entry or during the trial 9. 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) 10. Patients with Progressive Multifocal Leukoencephalopathy (PML), visceral Kaposi's Sarcoma (KS), and/or any lymphoma 11. Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at the screening visit 12. Patients who are receiving systemic chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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). |
| 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 |
| Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml | baseline to week 48 | — |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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). |
| Change in CD4+ Cell Count From Baseline to Week 2. | baseline to week 2 | Patients on-treatment, data within time windows |
| Change in CD4+ Cell Count From Baseline to Week 4. | baseline to week 4 | Patients on-treatment, data within time windows |
| Change in CD4+ Cell Count From Baseline to Week 6. | baseline to week 6 | Patients on-treatment, data within time windows |
| Change in CD4+ Cell Count From Baseline to Week 8. | baseline to week 8 | Patients on-treatment, data within time windows |
| Change in CD4+ Cell Count From Baseline to Week 12. | baseline to week 12 | Patients on-treatment, data within time windows |
| Change in CD4+ Cell Count From Baseline to Week 24. | baseline to week 24 | Patients on-treatment, data within time windows |
| Change in CD4+ Cell Count From Baseline to Week 36. | baseline to week 36 | Patients on-treatment, data within time windows |
| Change in CD4+ Cell Count From Baseline to Week 48. | baseline to week 48 | Patients on-treatment, data within time windows |
| Change in Fasting Plasma Total Cholesterol Level | baseline to week 48 | — |
| Change in Fasting Plasma Triglycerides Level | baseline to week 48 | — |
| Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level | baseline to week 48 | — |
| Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level | baseline to week 48 | — |
| Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio | baseline to week 48 | — |
| 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%. |
| Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group | baseline to week 48 | — |
| 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 |
| Percentage Adherence by Pill Count | baseline to week 48 | Number of pills not returned / number of treatment days in percent (%) |
| 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 |
| Incidence of Patients With AIDS Progression at Each Visit | baseline to week 52 | Cumulative incidence of patients with AIDS progression are shown |
| Proportion of Patients Reporting CNS Side Effects of Any Severity | baseline to week 52 | — |
| Proportion of Patients Reporting Hepatic Events of Any Severity | baseline to week 52 | — |
| Proportion of Patients Reporting Rash of Any Severity | baseline to week 52 | — |
| Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities | baseline to week 52 | — |
| 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. |
Countries
United States
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 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.
Participants by arm
| Arm | Count |
|---|---|
| Nevirapine (NVP) Plus Truvada Nevirapine 200 mg bis in die (BID) | 75 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD) | 77 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 9 |
| Overall Study | Lack of Efficacy | 6 | 0 |
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Nevirapine (NVP) Plus Truvada | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Total |
|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 10.4 | 35.9 years STANDARD_DEVIATION 9.7 | 36.8 years STANDARD_DEVIATION 10.1 |
| CD4+ count | 178.9 cells/mm^3 STANDARD_DEVIATION 105.3 | 183.5 cells/mm^3 STANDARD_DEVIATION 111.3 | 181.2 cells/mm^3 STANDARD_DEVIATION 108 |
| Log10 HIV viral load | 4.9 copies/mL STANDARD_DEVIATION 0.8 | 4.9 copies/mL STANDARD_DEVIATION 0.7 | 4.9 copies/mL STANDARD_DEVIATION 0.8 |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Male | 65 Participants | 71 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 50 / 75 | 61 / 77 |
| serious Total, serious adverse events | 10 / 75 | 7 / 77 |
Outcome results
Primary
Number of Participants With Virologic Response (VR)
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
Population: All treated patients. Early withdrawals were considered failures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With Virologic Response (VR) | Responders | 46 participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With Virologic Response (VR) | Nonresponders | 29 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With Virologic Response (VR) | Responders | 50 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With Virologic Response (VR) | Nonresponders | 27 participants |
Comparison: 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%.p-value: 0.714295% CI: [-0.183, 0.101]Cochran-Mantel-Haenszel
Secondary
AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
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
Population: All treated patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nevirapine (NVP) Plus Truvada | AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death | 1 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death | 3 Participants |
Secondary
Change in CD4+ Cell Count From Baseline to Week 12.
Patients on-treatment, data within time windows
Time frame: baseline to week 12
Population: Includes only treated patients with data in the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 12. | 123.1 cells/mm^3 | Standard Deviation 109.5 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 12. | 102.2 cells/mm^3 | Standard Deviation 103.9 |
Secondary
Change in CD4+ Cell Count From Baseline to Week 2.
Patients on-treatment, data within time windows
Time frame: baseline to week 2
Population: Includes only treated patients with data in the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 2. | 62.6 cells/mm^3 | Standard Deviation 80.9 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 2. | 61.0 cells/mm^3 | Standard Deviation 69.7 |
Secondary
Change in CD4+ Cell Count From Baseline to Week 24.
Patients on-treatment, data within time windows
Time frame: baseline to week 24
Population: Includes only treated patients with data in the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 24. | 131.8 cells/mm^3 | Standard Deviation 115.5 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 24. | 132.5 cells/mm^3 | Standard Deviation 86.8 |
Secondary
Change in CD4+ Cell Count From Baseline to Week 36.
Patients on-treatment, data within time windows
Time frame: baseline to week 36
Population: Includes only treated patients with data in the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 36. | 147.6 cells/mm^3 | Standard Deviation 120.7 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 36. | 120.5 cells/mm^3 | Standard Deviation 99.4 |
Secondary
Change in CD4+ Cell Count From Baseline to Week 4.
Patients on-treatment, data within time windows
Time frame: baseline to week 4
Population: Includes only treated patients with data in the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 4. | 76.4 cells/mm^3 | Standard Deviation 88.2 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 4. | 63.0 cells/mm^3 | Standard Deviation 72.6 |
Secondary
Change in CD4+ Cell Count From Baseline to Week 48.
Patients on-treatment, data within time windows
Time frame: baseline to week 48
Population: Includes only treated patients with data in the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 48. | 155.1 cells/mm^3 | Standard Deviation 118.8 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 48. | 160.4 cells/mm^3 | Standard Deviation 108.7 |
Secondary
Change in CD4+ Cell Count From Baseline to Week 6.
Patients on-treatment, data within time windows
Time frame: baseline to week 6
Population: Includes only treated patients with data in the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 6. | 87.2 cells/mm^3 | Standard Deviation 86 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 6. | 78.4 cells/mm^3 | Standard Deviation 67.6 |
Secondary
Change in CD4+ Cell Count From Baseline to Week 8.
Patients on-treatment, data within time windows
Time frame: baseline to week 8
Population: Includes only treated patients with data in the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 8. | 111.9 cells/mm^3 | Standard Deviation 100.2 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in CD4+ Cell Count From Baseline to Week 8. | 90.5 cells/mm^3 | Standard Deviation 85.2 |
Secondary
Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
Time frame: baseline to week 48
Population: All treated patients with data, Last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level | 9.6 mg/dl | Standard Deviation 11.8 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level | 3.5 mg/dl | Standard Deviation 15 |
p-value: 0.016495% CI: [0.9, 8.8]ANCOVA
Secondary
Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
Time frame: baseline to week 48
Population: All treated patients with data, Last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level | 8.7 mg/dl | Standard Deviation 21.5 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level | 6.9 mg/dl | Standard Deviation 32.2 |
p-value: 0.925795% CI: [-8.4, 9.3]ANCOVA
Secondary
Change in Fasting Plasma Total Cholesterol Level
Time frame: baseline to week 48
Population: All treated patients with data, Last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in Fasting Plasma Total Cholesterol Level | 18.2 mg/dl | Standard Deviation 26.5 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in Fasting Plasma Total Cholesterol Level | 13.8 mg/dl | Standard Deviation 39.5 |
p-value: 0.731595% CI: [-8.4, 11.9]ANCOVA
Secondary
Change in Fasting Plasma Triglycerides Level
Time frame: baseline to week 48
Population: All treated patients with data, Last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in Fasting Plasma Triglycerides Level | -4.7 mg/dl | Standard Deviation 87.6 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in Fasting Plasma Triglycerides Level | 8.4 mg/dl | Standard Deviation 120.4 |
p-value: 0.362595% CI: [-33.4, 12.3]ANCOVA
Secondary
Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
Time frame: baseline to week 48
Population: All treated patients with data, Last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio | -0.38 ratio | Standard Deviation 0.96 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio | -0.02 ratio | Standard Deviation 1.06 |
p-value: 0.037595% CI: [-0.64, -0.02]ANCOVA
Secondary
Change in Framingham Score
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
Population: All treated patients with data, Last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in Framingham Score | -0.09 percent 10-year risk | Standard Deviation 2.01 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in Framingham Score | 0.14 percent 10-year risk | Standard Deviation 2.66 |
p-value: 0.464595% CI: [-1.02, 0.47]ANCOVA
Secondary
Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
using 4-variable Modification of Diet in Renal Disease (MDRD) formula
Time frame: baseline to week 48
Population: Includes only treated patients with data for the specified time window
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48 | -0.06 ml/min/1.73m^2 | Standard Deviation 33.9 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48 | -12.81 ml/min/1.73m^2 | Standard Deviation 35.61 |
Secondary
Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group
Time frame: baseline to week 48
Population: Not calculated as no data on family history of cardiovascular disease were available
Secondary
Incidence of Patients With AIDS Progression at Each Visit
Cumulative incidence of patients with AIDS progression are shown
Time frame: baseline to week 52
Population: Full Analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 6 | 0 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 24 | 0 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 4 | 0 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 36 | 0 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 8 | 0 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 48 | 1 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 0 | 0 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 50 | 1 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 2 | 0 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | End of Study Visit | 2 participants |
| Nevirapine (NVP) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 12 | 0 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | End of Study Visit | 3 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 2 | 0 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 4 | 0 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 6 | 1 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 8 | 1 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 12 | 2 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 24 | 3 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 36 | 3 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 48 | 3 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 50 | 3 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Incidence of Patients With AIDS Progression at Each Visit | week 0 | 0 participants |
Secondary
Number of Participants With Genotypic Resistance at the Time of Virologic Failure.
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
Population: Includes only treated patients with data in the specified time window
Secondary
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 12
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment | HIV viral load < 400 copies/ml | 56 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment | HIV viral load ≥ 400 copies/ml | 6 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment | Missing data | 13 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment | HIV viral load < 400 copies/ml | 63 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment | HIV viral load ≥ 400 copies/ml | 7 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment | Missing data | 7 Participants |
Secondary
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 24
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment | HIV viral load ≥ 400 copies/ml | 6 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment | Missing data | 18 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment | HIV viral load < 400 copies/ml | 51 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment | HIV viral load ≥ 400 copies/ml | 3 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment | HIV viral load < 400 copies/ml | 63 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment | Missing data | 11 Participants |
Secondary
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 2
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment | HIV viral load < 400 copies/ml | 24 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment | HIV viral load ≥ 400 copies/ml | 44 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment | Missing data | 7 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment | HIV viral load < 400 copies/ml | 17 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment | HIV viral load ≥ 400 copies/ml | 51 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment | Missing data | 9 Participants |
Secondary
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 36
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment | HIV viral load < 400 copies/ml | 54 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment | HIV viral load ≥ 400 copies/ml | 3 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment | Missing data | 18 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment | HIV viral load < 400 copies/ml | 59 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment | HIV viral load ≥ 400 copies/ml | 1 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment | Missing data | 17 Participants |
Secondary
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 48
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment | HIV viral load < 400 copies/ml | 43 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment | HIV viral load ≥ 400 copies/ml | 1 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment | Missing data | 31 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment | HIV viral load < 400 copies/ml | 54 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment | HIV viral load ≥ 400 copies/ml | 2 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment | Missing data | 21 Participants |
Secondary
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 4
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment | HIV viral load < 400 copies/ml | 38 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment | HIV viral load ≥ 400 copies/ml | 27 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment | Missing data | 10 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment | HIV viral load < 400 copies/ml | 31 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment | HIV viral load ≥ 400 copies/ml | 41 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment | Missing data | 5 Participants |
Secondary
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 6
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment | HIV viral load < 400 copies/ml | 40 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment | HIV viral load ≥ 400 copies/ml | 21 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment | Missing data | 14 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment | HIV viral load < 400 copies/ml | 44 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment | HIV viral load ≥ 400 copies/ml | 23 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment | Missing data | 10 Participants |
Secondary
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 8
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment | HIV viral load < 400 copies/ml | 48 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment | HIV viral load ≥ 400 copies/ml | 11 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment | Missing data | 16 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment | HIV viral load < 400 copies/ml | 58 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment | HIV viral load ≥ 400 copies/ml | 15 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment | Missing data | 4 Participants |
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 12
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment | HIV viral load < 50 copies/ml | 42 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment | HIV viral load ≥ 50 copies/ml | 20 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment | Missing data | 13 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment | HIV viral load < 50 copies/ml | 43 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment | HIV viral load ≥ 50 copies/ml | 27 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment | Missing data | 7 Participants |
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 24
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment | HIV viral load < 50 copies/ml | 48 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment | HIV viral load ≥ 50 copies/ml | 9 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment | Missing data | 18 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment | HIV viral load < 50 copies/ml | 61 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment | HIV viral load ≥ 50 copies/ml | 5 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment | Missing data | 11 Participants |
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 2
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment | HIV viral load ≥ 50 copies/ml | 62 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment | Missing data | 7 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment | HIV viral load < 50 copies/ml | 6 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment | HIV viral load ≥ 50 copies/ml | 63 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment | Missing data | 9 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment | HIV viral load < 50 copies/ml | 5 Participants |
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 36
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment | HIV viral load ≥ 50 copies/ml | 4 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment | Missing data | 18 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment | HIV viral load < 50 copies/ml | 53 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment | HIV viral load ≥ 50 copies/ml | 5 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment | HIV viral load < 50 copies/ml | 55 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment | Missing data | 17 Participants |
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
HIV viral load \<50 copies/ml measured at Week 48 among observed cases on-treatment.
Time frame: baseline to week 48
Population: Only includes treated patients with data in the Week 48 time window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 | Responders | 42 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 | Nonresponders | 2 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 | Responders | 48 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 | Nonresponders | 8 Participants |
p-value: 0.147795% CI: [-0.03, 0.197]Cochran-Mantel-Haenszel
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 48
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment | HIV viral load ≥ 50 copies/ml | 2 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment | Missing data | 31 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment | HIV viral load < 50 copies/ml | 42 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment | HIV viral load ≥ 50 copies/ml | 8 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment | HIV viral load < 50 copies/ml | 48 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment | Missing data | 21 Participants |
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 4
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment | HIV viral load < 50 copies/ml | 12 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment | HIV viral load ≥ 50 copies/ml | 53 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment | Missing data | 10 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment | HIV viral load < 50 copies/ml | 10 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment | HIV viral load ≥ 50 copies/ml | 62 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment | Missing data | 5 Participants |
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 6
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment | HIV viral load < 50 copies/ml | 23 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment | HIV viral load ≥ 50 copies/ml | 38 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment | Missing data | 14 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment | HIV viral load < 50 copies/ml | 14 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment | HIV viral load ≥ 50 copies/ml | 53 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment | Missing data | 10 Participants |
Secondary
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment
Time frame: baseline to week 8
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment | HIV viral load < 50 copies/ml | 34 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment | HIV viral load ≥ 50 copies/ml | 25 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment | Missing data | 16 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment | HIV viral load < 50 copies/ml | 23 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment | HIV viral load ≥ 50 copies/ml | 50 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment | Missing data | 4 Participants |
Secondary
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
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
Population: All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response | At week 24 | 1 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response | At week 48 | 2 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response | At week 24 | 4 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response | At week 48 | 9 Participants |
Secondary
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
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
Population: All treated patients. Early withdrawals were considered failures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | Responders | 48 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | Nonresponders | 27 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | Responders | 51 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | Nonresponders | 26 Participants |
p-value: 0.647995% CI: [-0.167, 0.113]Cochran-Mantel-Haenszel
Secondary
Number of Participants With Virologic Success (FDA Definition)
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
Population: All treated patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Participants With Virologic Success (FDA Definition) | Nonresponders | 33 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Participants With Virologic Success (FDA Definition) | Responders | 42 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With Virologic Success (FDA Definition) | Nonresponders | 29 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Participants With Virologic Success (FDA Definition) | Responders | 48 Participants |
p-value: 0.370395% CI: [-0.215, 0.08]Cochran-Mantel-Haenszel
Secondary
Number of Patients With Virologic Rebound to >400 Copies/ml
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
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Number of Patients With Virologic Rebound to >400 Copies/ml | Rebound following response | 2 Participants |
| Nevirapine (NVP) Plus Truvada | Number of Patients With Virologic Rebound to >400 Copies/ml | No rebound following response | 55 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Patients With Virologic Rebound to >400 Copies/ml | Rebound following response | 6 Participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Number of Patients With Virologic Rebound to >400 Copies/ml | No rebound following response | 63 Participants |
Secondary
Percentage Adherence by Pill Count
Number of pills not returned / number of treatment days in percent (%)
Time frame: baseline to week 48
Population: All treated patients with data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Percentage Adherence by Pill Count | 94.3 percentage adherence | Standard Deviation 17.7 |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Percentage Adherence by Pill Count | 97.0 percentage adherence | Standard Deviation 8.1 |
Secondary
Proportion of Patients Reporting CNS Side Effects of Any Severity
Time frame: baseline to week 52
Population: All treated patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nevirapine (NVP) Plus Truvada | Proportion of Patients Reporting CNS Side Effects of Any Severity | 25 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Proportion of Patients Reporting CNS Side Effects of Any Severity | 23 participants |
Secondary
Proportion of Patients Reporting Hepatic Events of Any Severity
Time frame: baseline to week 52
Population: All treated patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nevirapine (NVP) Plus Truvada | Proportion of Patients Reporting Hepatic Events of Any Severity | 5 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Proportion of Patients Reporting Hepatic Events of Any Severity | 24 participants |
Secondary
Proportion of Patients Reporting Rash of Any Severity
Time frame: baseline to week 52
Population: All treated patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nevirapine (NVP) Plus Truvada | Proportion of Patients Reporting Rash of Any Severity | 21 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Proportion of Patients Reporting Rash of Any Severity | 19 participants |
Secondary
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
Time frame: baseline to week 52
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine (NVP) Plus Truvada | Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities | Grade 2 moderate | 25 participants |
| Nevirapine (NVP) Plus Truvada | Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities | Grade 3 severe | 8 participants |
| Nevirapine (NVP) Plus Truvada | Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities | Grade 4 potential lifethreatening | 7 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities | Grade 2 moderate | 31 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities | Grade 3 severe | 7 participants |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities | Grade 4 potential lifethreatening | 3 participants |
Secondary
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Time to response whereby patients withdrawing early were censored after their withdrawal
Time frame: baseline to week 48
Population: All treated patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nevirapine (NVP) Plus Truvada | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants | 57 days |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants | 84 days |
Comparison: Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine.p-value: 0.031495% CI: [0.46, 0.964]Regression, Cox
Secondary
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
Time frame: baseline to week 48
Population: All responders
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nevirapine (NVP) Plus Truvada | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml | 55 days |
| Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml | 84 days |
Comparison: Responders only~Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine.p-value: 0.017295% CI: [0.428, 0.921]Regression, Cox