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:
Participant gender:
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
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)