Status:
COMPLETED
Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Malaria
Human Immunodeficiency Virus
Eligibility:
FEMALE
16+ years
Phase:
PHASE3
Brief 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 w...
Detailed Description
Pregnant women will be scheduled to be seen in the study clinic every 4 weeks during their pregnancy. Women will be seen at 1 week, 6 weeks, and 3 months postpartum and every 3 months thereafter. In a...
Eligibility Criteria
Inclusion
- Intrauterine pregnancy confirmed by ultrasound
- Estimated gestational age between 12-28 weeks
- Confirmed to be HIV-infected by Uganda country standard rapid HIV test
- 16 years of age or older
- Residency within 30 km of the study clinic
- Provision of informed consent
- 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
- History of serious adverse event to TS or DP
- Refusal to take cART during pregnancy or as part of routine HIV care
- Active medical problem requiring inpatient evaluation at the time of screening
- Intention of moving more than 30 km from the study clinic
- Active WHO stage 4 condition not stable under treatment
- Signs or symptoms of early or active labor
- Currently on ritonavir
- Currently taking drugs associated with known risk of Torsades de pointes
- Currently taking CYP3A inhibitor medications which potentially inhibit the metabolism of piperaquine
- History of cardiac problems or fainting
Key Trial Info
Start Date :
December 9 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02282293
Start Date
December 9 2014
End Date
May 26 2016
Last Update
March 5 2019
Active Locations (1)
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1
IDRC Research Clinic - Tororo District Hospital
Tororo, Uganda