MedTrace Logo

PrEP in Breastfeeding Study

NCT02776748 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-09-21

No results posted yet for this study

Summary

The purpose of this study is to quantify the magnitude and extent of infant exposure to daily emtricitabine (FTC) /tenofovir disoproxil fumarate (TDF) via maternal breastmilk when taken pre-exposure prophylaxis (PrEP) by lactating HIV-uninfected women. The primary outcome is the steady state concentrations of emtricitabine and tenofovir in the infant plasma.

Conditions

  • HIV Pre-exposure Prophylaxis During Breastfeeding

Interventions

DRUG

FTC/TDF PrEP

Daily oral directly observed FTC/TDF PrEP administered to breastfeeding HIV-uninfected women

Sponsors & Collaborators

Principal Investigators

  • Jared M Baeten, MD, PhD · University of Washington

  • Kenneth K Mugwanya, MBChB, MS · University of Washington

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-05-31
Completion
2015-12-31

Countries

  • Kenya
  • Uganda

Study Locations

More Related Trials

Entities

Companies

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 NCT02776748 on ClinicalTrials.gov