Status:
COMPLETED
A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
3-12 years
Phase:
PHASE1
Brief Summary
To compare the safety, toxicity, and tolerance of two doses of ribavirin in combination with didanosine (ddI) to HIV-infected children. To determine the toxicity of ddI/ribavirin and compare it to the...
Detailed Description
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 ...
Eligibility 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
July 1 1998
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00000833
End Date
July 1 1998
Last Update
October 28 2021
Active Locations (15)
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1
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States, 200102916
2
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
3
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
4
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699