Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp)
with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly
reduce the risk of adverse birth outcomes compared to IPTp with SP alone or DP alone. This
double-blinded randomized controlled phase III trial of 2757 HIV uninfected pregnant women
enrolled at 12-20 weeks gestation will be randomized in equal proportions to one of three
IPTp treatment arms: 1) SP given every 4 weeks, or 2) DP given every 4 weeks, or 3) SP+DP
given every 4 weeks. SP or DP placebos will be used to ensure adequate blinding is achieved
in the study and follow-up will end 28 days after giving birth.
Phase:
Phase 3
Details
Lead Sponsor:
Grant Dorsey, M.D, Ph.D.
Collaborators:
Infectious Diseases Research Collaboration, Uganda National Institutes of Health (NIH)
Treatments:
Artenimol Dihydroartemisinin Fanasil, pyrimethamine drug combination Piperaquine Pyrimethamine Sulfadoxine