A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
2 other identifiers
interventional
20
2 countries
15
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
July 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +8 more criteria
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198, United States
Schneider Children's Hosp
New Hyde Park, New York, 11040, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457, United States
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067, Puerto Rico
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Van Dyke R
- STUDY CHAIR
McSherry G