Completed

A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

From 3 Months to 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Ribavirin, a broad spectrum antiviral agent, may enhance the antiretroviral activity of didanosine ( ddI ) without a concomitant increase in toxicity. Ribavirin alters the intracellular metabolism of ddI, enhancing the antiretroviral activity of the active form of ddI. Patients are divided into two cohorts. Subjects will be stratified by age 3 months to < 24 months and >= 24 months to 12 years. Fifty % of patients from each age group will be assigned to each cohort. Cohort 1 receives ddI monotherapy for 4 weeks, followed by combination ddl/ribavirin therapy for an additional 20 weeks. Cohort 2 receives combination ddI/ribavirin for 24 weeks. In both cohorts, after study medications are stopped, patients are treated with prescription antiretrovirals for 4 more weeks. \[AS PER AMENDMENT 7/2/96: Note: In each cohort of 10 subjects at least 2 of 5 children from the older half of the cohort will have an ICD p24 antigen at entry.\]

Official TitleA Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
NCT00000833
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 Months to 12 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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeAIDS-Related ComplexCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

Criteria

Inclusion Criteria Concurrent Medication: Recommended: * PCP prophylaxis. Allowed: * Acetaminophen for no more than 72 hours. * Immunoglobulin. * Corticosteroids. * Erythropoietin. * G-CSF and GM-CSF. * Ethionamide or isoniazid for TB if no alternative available. * Immunizations according to current recommendations. Patients must have: * HIV infection. * Immunologic abnormality or clinical symptoms as detailed in the Disease Status field. * No active AIDS-defining opportunistic infection or malignancy, no progressive encephalopathy attributable to HIV and no chronic persistent diarrhea. * Consent of parent or guardian. PER AMENDMENT 7/2/96: * At least 2 of the 5 children in the older half of each cohort must have an ICD p24 antigen concentration \>= 70 pg/ml at screening. Prior Medication: Allowed: * Up to 6 weeks of prior immunomodulator therapy. * Maternal immunomodulator or antiretroviral therapy, including during pregnancy. * Prior corticosteroids or intravenous immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Current grade 3 or worse neuropathy/lower motor neuropathy. * Clinical or laboratory grade 3 or worse toxicities. * Active serious bacterial infection. Concurrent Medication: Excluded: * Chemotherapy for active malignancy. * Antiretrovirals other than study drugs. * Immunomodulators unless specifically allowed. Patients with the following prior condition are excluded: * History of grade 3 or worse neuropathy/lower motor neuropathy. Prior Medication: Excluded: * Prior ddI or oral ribavirin. * Aerosolized ribavirin within 6 weeks prior to study entry. * Antiretroviral or immunomodulator therapy (other than corticosteroids or IVIG) within 1 week prior to blood draws for study entry. Ongoing drug or alcohol abuse.

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 15 locations

Suspended

Children's Hosp of Washington DC

Washington D.C., United StatesOpen Children's Hosp of Washington DC in Google Maps
Suspended

Howard Univ Hosp

Washington D.C., United States
Suspended

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, United States
Suspended

Tulane Univ / Charity Hosp of New Orleans

New Orleans, United States
Completed15 Study Centers