Phase 2
N=308
A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
HIV · Pregnancy Malaria · Sexually Transmitted Infection
Bottom Line
View on ClinicalTrials.gov: NCT03431168 ↗Enrolled (actual)
308
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Plasmodium Falciparum Peripheral Parasitemia — 8; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Azithromycin/TMPS (Drug); Placebo/TMPS (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasmodium Falciparum Peripheral Parasitemia |
8; 7 | — |
| PRIMARY Proportion With Composite STI Outcome |
2; 2 | — |
| SECONDARY Low Birthweight (<2500 Grams) |
4; 7 | — |
| SECONDARY Proportion With Adverse Birth Outcomes |
13; 20 | — |
| SECONDARY Maternal Adherence to the Prophylactic Regimen |
148; 148 | — |
| SECONDARY Proportion of Participants With Symptomatic Malaria |
13; 13 | — |
| SECONDARY Proportion With Placental Malaria |
7; 5 | — |
| SECONDARY Proportion With Maternal Anemia and Severe Maternal Anemia |
2; 2 | — |
| SECONDARY Composite STI Measure (Including All STI Tests) |
5; 5 | — |
| SECONDARY GBS Colonization |
8; 7 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT03431168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.