A Phase I Study to Evaluate the Safety and Toxicity of the Combination of Zidovudine and 2',3'-Dideoxyinosine (Didanosine) in Children With HIV Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Evaluation, Drug Therapy, Combination, Zidovudine
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Corticosteroids for treatment of lymphocytic interstitial pneumonitis. Concurrent Treatment: Allowed: Intravenous hyperalimentation. Patients must have the following: P-2 class symptomatic HIV infection as defined by CDC OR who are asymptomatic but whose total CD4 cell count is < 500 cells/mm3. Freedom from significant active opportunistic or other infection requiring specific therapy. Part B patients: Prior treatment with zidovudine (AZT) that was discontinued because of hematologic toxicity. Availability of a parent or legal guardian who is sufficiently reliable to give informed consent and follow necessary study procedures including administration of medications and return for follow-up visits. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection. History of acute or chronic pancreatitis. Patients with the following are excluded: Critically ill, clinically unstable, or receiving drug therapy for an opportunistic or other infection. History of acute or chronic pancreatitis. Prior Medication: Excluded: Antiretroviral or other antiviral agent within 14 days of entry into study. Immunomodulating agents, cytolytic chemotherapeutic agents, corticosteroids within 30 days (except for lymphocytic interstitial pneumonitis). Part A patients: Zidovudine (AZT) or didanosine (ddI). Part B patients: Didanosine (ddI). Prior Treatment: Excluded: Radiation therapy within 30 days. Intravenous immunoglobulin preparations within 14 days of entry into study.
Sites / Locations
- Children's Hosp of Los Angeles/UCLA Med Ctr