Overview

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