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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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 expected toxicity of ddI monotherapy. To determine the effect of concurrent ribavirin on the pharmacokinetics of ddI. To determine a dosage of ribavirin that would be suitable for a Phase II/III evaluation of ddI/ribavirin. 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.

Key facts

Study ID

NCT00000833

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Expected to finish

1998-07-01

Last updated by the study team

2021-10-28

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl — Newark, New Jersey, United States
• Schneider Children's Hosp — New Hyde Park, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Incarnation Children's Ctr / Columbia Presbyterian Med Ctr — New York, New York, United States
• Harlem Hosp Ctr — New York, New York, United States
• Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
• Glaxo Wellcome Inc — Research Triangle Park, North Carolina, United States
• Texas Children's Hosp / Baylor Univ — Houston, Texas, United States
• Univ of Puerto Rico / Univ Children's Hosp AIDS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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