Status:
COMPLETED
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00135343
Start Date
April 1 2004
End Date
October 1 2005
Last Update
April 14 2011
Active Locations (15)
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1
Local Institution
San Francisco, California, United States
2
Local Institution
Washington D.C., District of Columbia, United States
3
Local Institution
Atlantis, Florida, United States
4
Local Institution
Orlando, Florida, United States