Phase 4
Completed N=152
Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
Source: ClinicalTrials.gov NCT00552240 ↗Enrolled (actual)
152
Serious AEs
11.2%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Virologic Response (VR) — 46; 50; 29; 27 participants — p=0.7142
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Virologic Response (VR) |
46; 50; 29; 27 | 0.7142 |
| SECONDARY Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm |
48; 51; 27; 26 | 0.6479 |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 |
42; 48; 2; 8 | 0.1477 |
| SECONDARY Number of Participants With Virologic Success (FDA Definition) |
42; 48; 33; 29 | 0.3703 |
| SECONDARY Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants |
57; 84 | 0.0314 sig |
| SECONDARY Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml |
55; 84 | 0.0172 sig |
| SECONDARY Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response |
1; 4; 2; 9 | — |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment |
6; 5; 62; 63; 7; 9 | — |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment |
12; 10; 53; 62; 10; 5 | — |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment |
23; 14; 38; 53; 14; 10 | — |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment |
34; 23; 25; 50; 16; 4 | — |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment |
42; 43; 20; 27; 13; 7 | — |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment |
48; 61; 9; 5; 18; 11 | — |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment |
53; 55; 4; 5; 18; 17 | — |
| SECONDARY Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment |
42; 48; 2; 8; 31; 21 | — |
| SECONDARY Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment |
24; 17; 44; 51; 7; 9 | — |
| SECONDARY Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment |
38; 31; 27; 41; 10; 5 | — |
| SECONDARY Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment |
40; 44; 21; 23; 14; 10 | — |
| SECONDARY Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment |
48; 58; 11; 15; 16; 4 | — |
| SECONDARY Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment |
56; 63; 6; 7; 13; 7 | — |
| SECONDARY Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment |
51; 63; 6; 3; 18; 11 | — |
| SECONDARY Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment |
54; 59; 3; 1; 18; 17 | — |
| SECONDARY Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment |
43; 54; 1; 2; 31; 21 | — |
| SECONDARY Number of Patients With Virologic Rebound to >400 Copies/ml |
2; 6; 55; 63 | — |
| SECONDARY AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death |
1; 3 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 2. |
62.6; 61.0 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 4. |
76.4; 63.0 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 6. |
87.2; 78.4 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 8. |
111.9; 90.5 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 12. |
123.1; 102.2 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 24. |
131.8; 132.5 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 36. |
147.6; 120.5 | — |
| SECONDARY Change in CD4+ Cell Count From Baseline to Week 48. |
155.1; 160.4 | — |
| SECONDARY Change in Fasting Plasma Total Cholesterol Level |
18.2; 13.8 | 0.7315 |
| SECONDARY Change in Fasting Plasma Triglycerides Level |
-4.7; 8.4 | 0.3625 |
| SECONDARY Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level |
9.6; 3.5 | 0.0164 sig |
| SECONDARY Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level |
8.7; 6.9 | 0.9257 |
| SECONDARY Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio |
-0.38; -0.02 | 0.0375 sig |
| SECONDARY Change in Framingham Score |
-0.09; 0.14 | 0.4645 |
| SECONDARY Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group |
— | — |
| SECONDARY Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48 |
-0.06; -12.81 | — |
| SECONDARY Percentage Adherence by Pill Count |
94.3; 97.0 | — |
| SECONDARY Number of Participants With Genotypic Resistance at the Time of Virologic Failure. |
— | — |
| SECONDARY Incidence of Patients With AIDS Progression at Each Visit |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Proportion of Patients Reporting CNS Side Effects of Any Severity |
25; 23 | — |
| SECONDARY Proportion of Patients Reporting Hepatic Events of Any Severity |
5; 24 | — |
| SECONDARY Proportion of Patients Reporting Rash of Any Severity |
21; 19 | — |
| SECONDARY Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities |
25; 31; 8; 7; 7; 3 | — |
Eligibility Criteria
Inclusion criteria
- Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
- 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
- No prior nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) use of more than 10 days AND
- No prior use of other classes of antiretrovirals (ARVs) of more than 2 weeks duration
- Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed
- NVP and ATV/r susceptibility on screening HIV-1 genotypic resistance assay
- Adequate renal function defined as a calculated creatinine clearance greater than or equal to50 ml/min according to the Cockcroft-Gault formula
- Karnofsky score greater than or equal to 70 (see Appendix 10.7)
- Acceptable medical history, as assessed by the investigator
Exclusion criteria
- History of active drug or alcohol abuse within 2 years prior to study entry (at the investigators discretion)
- Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment
- 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
- 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)
- 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)
- Known hypersensitivity to any ingredients in nevirapine or atazanavir
- Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6
- Use of other investigational medications within 30 days before study entry or during the trial
- 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)
- Patients with Progressive Multifocal Leukoencephalopathy (PML), visceral Kaposi's Sarcoma (KS), and/or any lymphoma
- Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at the screening visit
- Patients who are receiving systemic chemotherapy
Data sourced from ClinicalTrials.gov (NCT00552240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.