Optimizing HIV prevention for pregnant women in Sub-Saharan Africa
Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
This study is testing different doses of a daily HIV prevention pill for pregnant women in Sub-Saharan Africa to see which one is safest and works best for both moms and their babies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (Lilongwe and 1 other locations) |
| Trial ID | NCT06435026 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the optimal dosage of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy. It involves a Phase 2a pharmacokinetic assessment where pregnant women will receive different doses of FTC/TDF to evaluate drug absorption and safety for both mothers and infants. Participants will be monitored closely during their second and third trimesters, with follow-up assessments postpartum to compare drug effects. The findings will inform future dosing recommendations for PrEP in pregnant populations.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 16 years or older, HIV-negative, and within 14 to 23 weeks of gestation.
Not a fit: Patients who are HIV-positive or have other significant health issues that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance HIV prevention strategies for pregnant women, improving maternal and infant health outcomes.
How similar studies have performed: Other studies have shown promise in optimizing PrEP regimens, but this specific approach for pregnant women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Maternal participants: * Aged 16 years or older * PrEP-eligible by local guidelines * Pregnant with a viable singleton pregnancy of between 14 and 23 completed weeks of gestation (from 14 weeks + 0 days to 23 weeks + 6 days) by ultrasonography at study entry * HIV-negative based on the study-specific screening algorithm * Hepatitis B surface antigen (HBsAg)-negative * Weight \>35 kg * Provided informed consent and expressed willingness to participate in study activities with their infants, including daily administration of oral PrEP under direct observation Infant participants: Infant participants enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise. If an infant is deemed too ill to undergo study procedures, procedures necessary for clinical management may be prioritized. Exclusion Criteria: Maternal participants will not enter the study if any of the following conditions are identified during the screening process: * Grade 2 or greater laboratory parameters for alanine transaminase (ALT) or aspartate aminotransferase (AST), hemoglobin (HB), and absolute neutrophil count (ANC). * Estimated creatinine clearance (CrCl) 90 mL/min or below, using the Cockcroft-Gault formula. * Known history or evidence of current significant disease process, including: hematological conditions, renal disease, unexplained bone fractures, environmental enteric dysfunction, or allergies/sensitivities to FTC/TDF. * Other current significant or uncontrolled disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator, would make participation in the study inappropriate or unsafe. * Fetuses with known or suspected major fetal anomaly, either from screening ultrasound or via medical record * Intention to leave the study site's catchment area before scheduled study exit. * Current use of prohibited medications * Concurrent use of other biomedical HIV prevention interventions (vaginal ring, injectable PrEP, any investigational prevention product).
Where this trial is running
Lilongwe and 1 other locations
- Bwaila District Hospital — Lilongwe, Malawi (Not_yet_recruiting)
- Seke North CRS — Harare, Zimbabwe (Recruiting)
Study contacts
- Principal investigator: Benjamin Chi, MD, MSc — University of North Carolina, Chapel Hill
- Study coordinator: Rassil Barada, MPH
- Email: Rassil_Barada@med.unc.edu
- Phone: 9194452864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.