To evaluate the safety and tolerance of adefovir dipivoxil and indinavir administered orally in combination with zidovudine, lamivudine, or stavudine in HIV-infected patients with CD4 cell counts \>= 100 cells/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (500 copies/ml) by 20 weeks of study therapy and the average reduction in HIV-1 RNA from baseline through study week 20. To evaluate the durability of the antiviral response through 48 weeks of study in patients who continue on study therapy after week 24.
This protocol is a stratified, randomized, open-label study of the safety and efficacy of adefovir dipivoxil with indinavir as quadruple therapy in combination with zidovudine and lamivudine, or as triple combination administered with either zidovudine or lamivudine or stavudine for 48 weeks in the treatment of HIV-infected patients with CD4 cell counts \>= 100/mm3 and an HIV-1 RNA baseline copy number \>= 5000 copies/ml. Patients will be randomized to adefovir dipivoxil, indinavir, zidovudine, and lamivudine or adefovir dipivoxil, indinavir, and a nucleoside inhibitor (randomly assigned to receive zidovudine, lamivudine, or stavudine) or to indinavir, zidovudine, and lamivudine. Additionally, a daily dose of L-carnitine will be administered to all patients randomized to an arm containing adefovir dipivoxil.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
100
Phoenix Body Positive
Phoenix, Arizona, United States
AIDS Healthcare Foundation Labs
Los Angeles, California, United States
Davies Med Ctr
San Francisco, California, United States
Blick Med Associates
Greenwich, Connecticut, United States
George Washington Med Ctr
Washington D.C., District of Columbia, United States
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, United States
Johns Hopkins Univ School of Medicine
Baltimore, Maryland, United States
Community Research Initiative
Brookline, Massachusetts, United States
Community Research Initiative on AIDS
New York, New York, United States
Saint Vincent's AIDS Ctr
New York, New York, United States
...and 5 more locations
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