Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants

• Status: Completed
• Trial end date: 2018-05-14
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

Inclusion Criteria:

1. Pregnancy confirmed by positive urine pregnancy test or intrauterine pregnancy by ultrasound

2. Estimated gestational age between 12-20 weeks

3. Confirmed to be HIV uninfected by rapid test

4. 16 years of age or older

5. Residency within 30km of the study clinic

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

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

8. Plan to deliver in the hospital

Exclusion Criteria:

1. History of serious adverse event to SP or DP

2. Active medical problem requiring inpatient evaluation at the time of screening

3. Intention of moving more than 30km from the study clinic

4. Chronic medical condition requiring frequent medical attention

5. Prior SP preventive therapy or any other antimalarial therapy during this pregnancy

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