Prevention of Malaria in HIV-uninfected Pregnant Women and Infants

• Status: Completed
• Trial end date: 2018-12-04
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

Inclusion Criteria:

• Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by ultrasound

• Estimated gestational age between 12-20 weeks

• Confirmed to be HIV uninfected by rapid test

• 16 years of age or older

• Resident of Busia District, Uganda

• Provision of informed consent by the pregnant woman for herself and her unborn child

• Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol

• Plan to deliver in the hospital

Exclusion Criteria:

• History of serious adverse event to SP or DP

• Active medical problem requiring inpatient evaluation at the time of screening

• Intention of moving outside of Busia District, Uganda

• Chronic medical condition requiring frequent medical attention

• Prior SP preventive therapy or any other antimalarial therapy during this pregnancy

• Early or active labor (documented by cervical change with uterine contractions)