Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: tenofovir DF 300 mg QD; tenofovir DF 300 mg QD; emtricitabine 200 mg QD; emtricitabine 200 mg QD; Nevirapine 200 mg BID; Atazanavir 300 mg; Ritonavir 100 mg
Intervention description: 300 mg QD; 300 mg QD; 200 mg QD; 200 mg QD; 200 mg BID; 300 mg QD; 100 mg QD
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine; Nevirapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        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