Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)

• Status: Completed
• Trial end date: 2016-05-26
• Target enrollment: 0
• Participant gender: Female

Summary

This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women between 12 and 28 weeks gestation will be randomized to receive enhanced malaria chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo. Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of age to which the mothers were randomized. All women will receive daily trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be considered a study drug only in infants and children beginning 6 weeks after cessation of breastfeeding and upon exclusion of HIV infection. Women and their children will be followed for 36 months after delivery. In a subset of the study population, the investigators will conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP and EFV. The investigators will also measure HIV-related outcomes among the women enrolled in the study. The investigators will test the hypothesis that for HIV-infected mothers and HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected pregnant women and their children will reduce the incidence of malaria among children from 0 to 24 months of age and improve the development of naturally acquired antimalarial immunity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine; Sulfamethoxazole; Trimethoprim

Criteria

Inclusion Criteria:

1. Intrauterine pregnancy confirmed by ultrasound

2. Estimated gestational age between 12-28 weeks

3. Confirmed to be HIV-infected by Uganda country standard rapid HIV test

4. 16 years of age or older

5. Residency within 30 km of the study clinic

6. Provision of informed consent

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 TS or DP

2. Refusal to take cART during pregnancy or as part of routine HIV care

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

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

5. Active WHO stage 4 condition not stable under treatment

6. Signs or symptoms of early or active labor

7. Currently on ritonavir

8. Currently taking drugs associated with known risk of Torsades de pointes

9. Currently taking CYP3A inhibitor medications which potentially inhibit the metabolism of piperaquine

10. History of cardiac problems or fainting