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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000833
First received: November 2, 1999
Last updated: May 1, 2012
Last verified: May 2012

November 2, 1999
May 1, 2012
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Complete list of historical versions of study NCT00000833 on ClinicalTrials.gov Archive Site
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A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.

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.

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.]

Interventional
Phase 1
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Ribavirin
  • Drug: Didanosine
Not Provided
McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 1998
Not Provided

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.

Both
3 Months to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00000833
ACTG 274, 11250
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Van Dyke R
Study Chair: McSherry G
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP