A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Efavirenz; Ritonavir

Criteria

Inclusion Criteria:

• Provide written informed consent

• HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3

• Antiretroviral (ARV) naive prior to enrollment

• Normal plasma triglycerides ≤ 200 mg/dL

• Women of child-bearing age must use effective barrier contraception

Exclusion Criteria:

• Pregnancy or breast feeding

• Evidence of resistance to antiretroviral drugs

• History of elevated blood cholesterol or triglycerides

• History of diabetes

• Hypersensitivity to any component of the study drugs

• Any cholesterol or triglyceride lowering medications in the past six months

• Use of growth hormone, megestrol acetate, or anabolic steroids in the past six months

• Imprisonment or involuntary incarceration for medical treatment