Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)

• Status: Not yet recruiting
• Trial end date: 2028-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial is a prospective, multi-center, randomized comparison study of 2 Pre-Exposure Prophylaxis (PrEP) pharmacokinetic (PK) dosing regimens from 1st trimester through 12 weeks following delivery (postpartum) to achieve study objectives which include PK, safety monitoring for maternal and fetal/infant safety signals, and adherence.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• age 18 years or older

• Able to speak English, French, or Spanish

• Able and willing to provide written informed consent

• Viable first (preferable) or second trimester intrauterine pregnancy

• Creatinine clearance >70 ml/min

• Negative HIV test and no signs/symptoms of acute HIV infection,

• Documented negative hepatitis B virus status.

Exclusion Criteria:

• HIV positive at any time in the study. All neonates of mothers participating in the trial will be recruited, regardless of gestational age at delivery or congenital anomalies/comorbidities.