The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.
In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
120
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, United States
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, United States
Med Ctr of Delaware
Wilmington, Delaware, United States
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Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, United States
Rush Presbyterian Saint Lukes Med Ctr
Chicago, Illinois, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Massachusetts Gen Hosp
Boston, Massachusetts, United States
Columbia Presbyterian Hosp
New York, New York, United States
AIDS TMT Unit / Univ Hosp
Stony Brook, New York, United States
Vanderbilt Clinic
Nashville, Tennessee, United States
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