Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
- Conditions
- HIVPreventionPregnancy
- Registration Number
- NCT06435026
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 54
Inclusion Criteria:<br><br>Maternal participants:<br><br> - Aged 16 years or older<br><br> - PrEP-eligible by local guidelines<br><br> - Pregnant with a viable singleton pregnancy of between 14 and 23 completed weeks of<br> gestation (from 14 weeks + 0 days to 23 weeks + 6 days) by ultrasonography at study<br> entry<br><br> - HIV-negative based on the study-specific screening algorithm<br><br> - Hepatitis B surface antigen (HBsAg)-negative<br><br> - Weight >35 kg<br><br> - Provided informed consent and expressed willingness to participate in study<br> activities with their infants, including daily administration of oral PrEP under<br> direct observation<br><br>Infant participants:<br><br>Infant participants enter the study with their mother as unborn infants. There are no<br>specific eligibility criteria for infant participation otherwise. If an infant is deemed<br>too ill to undergo study procedures, procedures necessary for clinical management may be<br>prioritized.<br><br>Exclusion Criteria:<br><br>Maternal participants will not enter the study if any of the following conditions are<br>identified during the screening process:<br><br> - Grade 2 or greater laboratory parameters for alanine transaminase (ALT) or aspartate<br> aminotransferase (AST), hemoglobin (HB), and absolute neutrophil count (ANC).<br><br> - Estimated creatinine clearance (CrCl) 90 mL/min or below, using the Cockcroft-Gault<br> formula.<br><br> - Known history or evidence of current significant disease process, including:<br> hematological conditions, renal disease, unexplained bone fractures, environmental<br> enteric dysfunction, or allergies/sensitivities to FTC/TDF.<br><br> - Other current significant or uncontrolled disease process (active or chronic),<br> substance use, or social circumstances that, in the judgment of the site<br> investigator, would make participation in the study inappropriate or unsafe.<br><br> - Fetuses with known or suspected major fetal anomaly, either from screening<br> ultrasound or via medical record<br><br> - Intention to leave the study site's catchment area before scheduled study exit.<br><br> - Current use of prohibited medications<br><br> - Concurrent use of other biomedical HIV prevention interventions (vaginal ring,<br> injectable PrEP, any investigational prevention product).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs)
- Secondary Outcome Measures
Name Time Method Maternal grade >/= 2 adverse events;Adverse pregnancy outcomes