Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
This study is an open-label, single site, randomized controlled trial comparing protease
inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected
pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is
designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will
have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART
regimen. The primary study endpoint of the study is placental malaria. This study also
enrolls the infants of these women at the time of delivery.
Phase:
Phase 3
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Efavirenz HIV Protease Inhibitors Lamivudine Lopinavir Protease Inhibitors Ritonavir Zidovudine