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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Page 1 of 4 (15 locations)

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