Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
Status:
Completed
Trial end date:
2018-12-04
Target enrollment:
Participant gender:
Summary
This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected
pregnant women and the children born to them. HIV uninfected women at 12-20 weeks gestation
will be randomized in equal proportions to one of two intermittent preventive treatment in
pregnancy (IPTp) treatment arms: 1) monthly sulfadoxine-pyrimethamine (SP), or 2) monthly
dihydroartemisinin-piperaquine (DP). Both interventions arms will have either SP or DP
placebo to ensure adequate blinding is achieved in the study. Follow-up for the pregnant
women will end approximately 6 weeks after giving birth. All children born to mothers
enrolled in the study will be followed from birth until they reach 12 months of age.
Phase:
Phase 3
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Bill and Melinda Gates Foundation Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Artemisinins Artenimol Dihydroartemisinin Fanasil, pyrimethamine drug combination Piperaquine Pyrimethamine Sulfadoxine