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Prevention of Malaria in HIV-uninfected Pregnant Women and Infants

NCT02793622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 782

Last updated 2021-04-14

Study results available
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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.

Conditions

Interventions

DRUG

Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy

DRUG

Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Grant Dorsey, MD PhD · University of California, San Francisco

  • Diane V Havlir, MD · University of California, San Francisco

  • Moses Kamya, MBChB MMed PhD · Makarere Univeritys ; Infectious Disease Research Collaboration

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-12-04
Completion
2018-12-04

Countries

  • Uganda

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793622 on ClinicalTrials.gov