HIV Infections
Conditions
Keywords
Didanosine, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule
Brief summary
To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration. The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
Detailed description
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity. Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks. PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.
Interventions
DRUGZidovudine
DRUGDidanosine
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb
Glaxo Wellcome
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed