A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
Trial Summary
What is the purpose of this trial?
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.
Research Team
Van Dyke R
Principal Investigator
McSherry G
Principal Investigator
Eligibility Criteria
Inclusion Criteria
Treatment Details
Interventions
- Didanosine (ddI) (Antiretroviral Agent)
- Ribavirin (Antiviral Agent)
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Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Dr. Jeanne Marrazzo
National Institute of Allergy and Infectious Diseases (NIAID)
Chief Executive Officer since 2023
MD, MPH
Dr. H. Clifford Lane
National Institute of Allergy and Infectious Diseases (NIAID)
Chief Medical Officer
MD