A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
Status:
Completed
Trial end date:
1998-06-01
Target enrollment:
Participant gender:
Summary
To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in
combination with zidovudine (AZT) in HIV-infected infants.
PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the
safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in
log10 RNA, of the two study arms.
Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and
rapid decline of CD4 count and immunologic function. Combination therapy may be preferred
over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is
little information on ddI monotherapy in young infants less than 90 days and no information
on the use of combination therapy in this population.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)