Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants
Status:
Completed
Trial end date:
2018-05-14
Target enrollment:
Participant gender:
Summary
This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected
pregnant women and the children born to them. The study interventions will be divided into
two phases. In the first phase, HIV uninfected women at 12-20 weeks gestation will be
randomized in equal proportions to one of three intermittent preventive therapy in pregnancy
(IPTp) treatment arms: 1) 3 doses of sulfadoxine-pyrimethamine (SP), 2) 3 doses of
dihydroartemisinin-piperaquine (DP), or 3) monthly DP. All three interventions arms will have
either SP or DP placebo to ensure adequate blinding is achieved. Follow-up for the pregnant
women will end approximately 6 weeks after giving birth. In the second phase of the study,
all children born to mothers enrolled in the study will be followed from birth until they
reach 36 months of age. Children born to mothers randomized to receive 3 doses of SP during
pregnancy will receive DP every 3 months between 2-24 months of age. Children born to mothers
randomized to receive 3 doses of DP or monthly DP during pregnancy will receive either DP
every 3 months or monthly DP between 2-24 months of age. To ensure adequate blinding,
children who will receive DP every 3 months will be given DP placebo during the months they
will not be taking DP. Children will then be followed an additional year between 24-36 months
of age following the interventions. We will test the hypothesis that IPT with DP will
significantly reduce the burden of malaria in pregnancy and infancy and improve the
development of naturally acquired antimalarial immunity.
Phase:
Phase 3
Details
Lead Sponsor:
Grant Dorsey, M.D, Ph.D. University of California, San Francisco
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Treatments:
Artemisinins Artenimol Dihydroartemisinin Fanasil, pyrimethamine drug combination Piperaquine Pyrimethamine Sulfadoxine