Overview
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
Status:
Completed
Completed
Trial end date:
2005-10-01
2005-10-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
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