A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
NCT ID: NCT00000833
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
1998-07-31
Brief Summary
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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.
Detailed Description
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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. \[AS PER AMENDMENT 7/2/96: Note: In each cohort of 10 subjects at least 2 of 5 children from the older half of the cohort will have an ICD p24 antigen at entry.\]
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Ribavirin
Didanosine
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Months
12 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Van Dyke R
Role: STUDY_CHAIR
McSherry G
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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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
Other Identifiers
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11250
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 274
Identifier Type: -
Identifier Source: org_study_id