Status:
COMPLETED
A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
HIV
Pregnancy Malaria
Eligibility:
FEMALE
16-55 years
Phase:
PHASE2
Brief Summary
More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malari...
Detailed Description
The World Health Organization (WHO) recommends malaria prophylaxis for all pregnant women living in endemic areas in order to reduce maternal anemia, low birth weight and perinatal mortality by 25-45%...
Eligibility Criteria
Inclusion
- Confirmed HIV-infection (documented in medical record)
- Age ≥16 years
- Confirmed pregnancy, \<28 weeks estimated gestational age (by best obstetric estimate which may include ultrasound or fundal height and LMP)
- Live singleton pregnancy
- Receiving prenatal care at Mboppi Hospital or Mutengene Hospital
- Plan to receive follow up prenatal care and deliver at study facility
- Capable of providing written informed consent
- Able and agree to come to facility for febrile episodes or acute illness during pregnancy (with reimbursement of transportation costs).
- Agree to avoid antimalarial medications outside of study protocol.
Exclusion
- Severe anemia (last hemoglobin \<6)
- History of severe adverse reaction to co-trimoxazole or azithromycin
- Active medical problem requiring inpatient evaluation at the time of screening
- Intention of moving far away from the facility during pregnancy or not likely to return for follow up care or delivery
- Signs or symptoms of early or active labor
- History of severe cardiac disease (including congestive heart failure, severe valvular disease or arrhythmias).
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT03431168
Start Date
March 7 2018
End Date
January 1 2022
Last Update
November 27 2023
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294