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

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