A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
Status:
Completed
Trial end date:
2003-11-01
Target enrollment:
Participant gender:
Summary
To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral
administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile
to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in
this population, defined as the ability to take oral doses and lack of vomiting within 30
minutes of receiving oral study doses.
The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not
practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV
ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more
practical method of delivering ZDV during labor and delivery that, at minimum, will
approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would
enable women to start an intensive ZDV regimen during early labor, even prior to reaching the
hospital.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)