A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.
Status:
Completed
Trial end date:
1998-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)