A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

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 malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Azithromycin; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).