At a glance
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Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
In Brief
A Phase 3 clinical trial evaluating Lopinavir/ritonavir, Efavirenz, and 2 other interventions for Malaria and HIV Infections. Completed, enrolled 389 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
LPV 200mg/r 50mg
600mg
Zidovudine 300 mg
Lamivudine 150 mg