A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule
Eligibility Criteria
Inclusion Criteria Patients must have: HIV-1 seropositivity. CD4 count >= 550 cells/mm3. Asymptomatic disease. No prior antiretroviral therapy. Consent of parent or guardian if less than 18 years old. PER AMENDMENT 6/18/96: Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Medical condition that precludes study compliance. Concurrent Medication: Excluded: Antiretrovirals other than study drugs. Biologic response modifiers including erythropoietin and G-CSF. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Systemic radiation therapy. Patients with the following prior conditions are excluded: History of grade 2 or worse peripheral neuropathy. History of pancreatitis or factors predisposing to pancreatitis. Prior Medication: Excluded: Prior antiretrovirals. Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry. Chronic alcoholism.
Sites / Locations
- Univ of Alabama at Birmingham
- San Francisco Gen Hosp
- Univ of Colorado Health Sciences Ctr
- Univ of Miami School of Medicine
- Northwestern Univ Med School
- Cook County Hosp
- Rush Presbyterian - Saint Luke's Med Ctr
- Louis A Weiss Memorial Hosp
- Illinois Masonic Med Ctr
- Indiana Univ Hosp
- Methodist Hosp of Indiana / Life Care Clinic
- Johns Hopkins Hosp
- Harvard (Massachusetts Gen Hosp)
- Brigham and Women's Hosp
- Jack Weiler Hosp / Bronx Municipal Hosp
- Beth Israel Med Ctr
- Bellevue Hosp / New York Univ Med Ctr
- Univ of Rochester Medical Center
- Univ of North Carolina
- Univ of Cincinnati
- Ohio State Univ Hosp Clinic
- Univ of Washington