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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00135343

Run by

Bristol-Myers Squibb

People needed

60

Starts

2004-04-01

Expected to finish

2005-10-01

Last updated by the study team

2011-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution — San Francisco, California, United States
• Local Institution — Washington D.C., District of Columbia, United States
• Local Institution — Atlantis, Florida, United States
• Local Institution — Orlando, Florida, United States
• Local Institution — South Miami, Florida, United States
• Local Institution — Tampa, Florida, United States
• Local Institution — New Orleans, Louisiana, United States
• Local Institution — Boston, Massachusetts, United States
• Local Institution — Berkley, Michigan, United States
• Local Institution — St Louis, Missouri, United States
• Local Institution — Huntersville, North Carolina, United States
• Local Institution — Clumbia, South Carolina, United States
• Local Institution — Austin, Texas, United States
• Local Institution — Dallas, Texas, United States
• Local Institution — Hampton, Virginia, United States

Full record on ClinicalTrials.gov

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