Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies
Status:
Completed
Trial end date:
2001-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus
lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to
their babies after birth.
Pregnant women who are HIV-positive are at risk of giving HIV to their babies during
pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women
from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against
HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV
infection from mother to infant but studies are needed to determine whether they are safe and
effective during pregnancy.
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)