drugset / Trial / NCT03834909
Pre-Exposure Prophylaxis Dosing in Pregnancy to Optimize HIV Prevention (PREP-P)
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2022-04
- Primary completion
- 2027-09
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | — |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 600 mg | — |
| Subject | emtricitabine | Other / unclassified | 200 mg | — |
| Subject | emtricitabine | Other / unclassified | 400 mg | — |