A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children
Status:
Completed
Trial end date:
1994-03-01
Target enrollment:
Participant gender:
Summary
AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected
pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and
its metabolites in newborns of HIV-1 infected mothers who receive IV AZT only during labor;
to evaluate the safety of IV AZT administered by continuous infusion to HIV-1 infected
laboring women and their infants. Original design: To determine the distribution and
elimination of zidovudine (AZT) in the body as well as its safety in the treatment of
pregnant women and their unborn children. The information derived from this study is required
in order to design a future study that will assess the efficacy of AZT in reducing the
transmission rate of HIV-1 from seropositive women to their fetus by treating them during the
third trimester of pregnancy.
An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to
their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously
demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult
patients; benefits of treatment include decreased mortality rate, decreased incidence of
opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children,
however, have resulted in uncontrolled information regarding clinical efficacy. The present
study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and
oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the
safety and efficacy of such treatment in their newborns.
It is hoped that the results will be instrumental in designing future studies to assess the
efficacy of AZT in reducing the transmission risk of HIV-1.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)