Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Resistance, Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, Indinavir, RNA, Viral, Adenine, efavirenz
Eligibility Criteria
Inclusion Criteria Patients must have: Serologically documented HIV infection. Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml. Parental consent for patients under 18. Nelfinavir-Failure Group: Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent. Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold). Control Group: Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks. Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's. Exclusion Criteria Prior Medication: Excluded: Control group: Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors. Required: Nelfinavir-failure patients: At least 16 weeks of nelfinavir. Control group: At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.
Sites / Locations
- LAC / USC Med Ctr / Infectious Diseases
- Yale Univ / AIDS Clinical Trials Unit
- Med Ctr of Delaware
- Hawaii AIDS Clinical Trial Unit
- Rush Presbyterian Saint Lukes Med Ctr
- Johns Hopkins Hosp
- Massachusetts Gen Hosp
- Columbia Presbyterian Hosp
- AIDS TMT Unit / Univ Hosp
- Vanderbilt Clinic
- Oaklawn Physicians Group