A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women
Status:
Completed
Trial end date:
2001-06-01
Target enrollment:
Participant gender:
Summary
To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI)
administration in third trimester pregnant women who are HIV positive but are either
intolerant or resistant to zidovudine (AZT). To collect data on infant toxicity following
maternal treatment with ddI during the third trimester of pregnancy.
AZT may not be the optimal antiretroviral agent for all pregnant women requiring therapy for
HIV infection. Although ddI has been approved for use in HIV-infected adults and older
children, the safety and pharmacokinetics of ddI in pregnant women has not yet been
determined.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)