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
Zidovudine
+ Didanosine
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
New approaches to using available agents may provide increased or improved treatment options for AIDS. Combination therapy is expected to play a major role in improving survival and quality of life for HIV-infected individuals. AZT and ddI are two agents that have been most extensively evaluated and for which the evidence for antiretroviral effectiveness is strongest. Patients take AZT and ddI on an empty stomach; ddI is taken 2 minutes after taking antacid. Part A patients receive AZT plus ddI each at ranging doses. Patients in part B may receive a higher dose of ddI than patients in part A. The first patients enrolled are given the lowest dose. Subsequent patients receive increasingly higher doses until a dose limiting toxicity occurs.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.85 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 3 Months to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, United StatesOpen Children's Hosp of Los Angeles/UCLA Med Ctr in Google Maps