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

NCT03834909 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-04-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Standard dose Truvada®

TDF/FTC fixed dose combination, 300 mg TDF/200 mg FTC, one tablet each day

DRUG

Pregnancy-adjusted dose Truvada®

TDF/FTC fixed dose combination, 300 mg TDF/200 mg FTC, two tablets each day

Sponsors & Collaborators

Principal Investigators

  • Craig Hendrix, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2027-09-30
Completion
2028-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834909 on ClinicalTrials.gov