Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Zidovudine, Nevirapine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Chemoprophylaxis for Pneumocystis carinii pneumonia. Antibiotics, antifungals, and antiviral medications, as clinically indicated. Regularly prescribed medication such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or any other medications deemed appropriate by the primary care provider. Concurrent Treatment: Allowed: Limited localized radiation therapy to the skin. Prior Medication: Required: AZT (minimum 300 mg/day) for at least 1 month (uninterrupted) but no more than 2 years immediately prior to study entry. Patients must have: Asymptomatic HIV infection. CD4 count 300-600 cells/mm3. No plasma/serum PCR for codon 215 mutation at screening. Prior AZT monotherapy. NOTE: All Department of Defense (DOD)-eligible patients must be at least 18 years of age. Enrollment of women is encouraged. AS PER AMENDMENT 04/03/95: DOD female patients must have a negative pregnancy test within 48 hours prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Symptomatic grade 2 or worse peripheral neuropathy. Unable to swallow capsules and tablets. Other medical condition that contraindicates study participation. Concurrent Medication: Excluded: Systemic cytotoxic chemotherapy. Biologic response modifiers (such as interferon, ampligen, or PEG-IL2). Anti-HIV agents other than study drugs. Other investigational agents. Foscarnet unless clinically indicated for unresponsive herpes virus infection. Chronic antacid or H-2 blocker use. Rifampin or rifamycin class agents. Antibiotics containing clavulanic acid. Concurrent Treatment: Excluded: Radiation therapy other than limited localized therapy to skin. Patients with the following prior condition are excluded: History of pancreatitis. Prior Medication: Excluded: Prior therapy with nucleoside or non-nucleoside antiretroviral agents other than AZT. Immune modulating therapies (e.g., IFN-alpha, gp160) within 60 days prior to screening. Prior Treatment: Excluded: Blood transfusion within the preceding 2 weeks. Illicit drug or alcohol abuse.
Sites / Locations
- UCLA CARE Ctr
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
- San Mateo AIDS Program / Stanford Univ
- Stanford Univ Med Ctr
- Harbor UCLA Med Ctr
- Univ of Colorado Health Sciences Ctr
- Georgetown Univ Med Ctr
- Children's Hosp of Washington DC
- George Washington Univ / Hershey Med Ctr
- Walter Reed Army Med Ctr
- Emory Univ Hosp / Pediatrics
- Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
- Queens Med Ctr
- Univ of Hawaii
- Indiana Univ Hosp
- Univ of Iowa Hosp and Clinic
- State of MD Div of Corrections / Johns Hopkins Univ Hosp
- Johns Hopkins Hosp
- Natl Naval Med Ctr
- Fitzsimmons Army Med Ctr
- Beth Israel Deaconess Med Ctr
- Hennepin County Med Clinic
- Univ of Minnesota
- St Paul Ramsey Med Ctr
- Univ of Nebraska Med Ctr
- Adirondack Med Ctr at Saranac Lake
- Albany Med College / Division of HIV Medicine A158
- Mid - Hudson Care Ctr
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- Comprehensive Health Care Ctr / Bronx Municipal Hosp
- Montefiore Family Health Ctr / Bronx Municipal Hosp
- Jack Weiler Hosp / Bronx Municipal Hosp
- Montefiore Med Ctr / Bronx Municipal Hosp
- Montefiore Med Ctr Adolescent AIDS Program
- North Central Bronx Hosp / Bronx Municipal Hosp
- SUNY / Erie County Med Ctr at Buffalo
- Bellevue Hosp / New York Univ Med Ctr
- Columbia Presbyterian Med Ctr
- Harlem Hosp Ctr
- Univ of Rochester Medical Center
- SUNY / State Univ of New York
- Univ of North Carolina
- Carolinas Med Ctr
- Wake County Dept of Health
- Case Western Reserve Univ
- MetroHealth Med Ctr
- Ohio State Univ Hosp Clinic
- Med College of Ohio
- Milton S Hershey Med Ctr
- Univ of Pennsylvania at Philadelphia
- Thomas Jefferson Univ Hosp
- Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
- Vanderbilt Univ Med Ctr
- Univ of Texas Galveston
- Wilford Hall Med Ctr
- Brooke Army Med Ctr
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
- San Juan City Hosp