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Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum

NCT03386578 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2025-02-19

Study results available
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Summary

The purpose of this study was to evaluate the pharmacokinetics, feasibility, acceptability, and safety of a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) as oral daily pre-exposure prophylaxis (PrEP) to prevent HIV during pregnancy and postpartum in adolescents and young women and their infants.

Conditions

  • HIV Infections

Interventions

DRUG

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

200 mg/300 mg of FTC/TDF administered orally as a fixed-dose combination tablet once daily

BEHAVIORAL

Behavioral HIV risk reduction package

Included cohort-appropriate SMS messages.

BEHAVIORAL

Enhanced adherence support

Included two-way SMS messaging and tailored counseling with drug level feedback.

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Benjamin Chi, MD, MSc · University of North Carolina, Chapel Hill

  • Lynda Stranix-Chibanda, MBChB, MMED · University of Zimbabwe Faculty of Medicine and Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
24 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2023-10-25
Completion
2024-02-24
FDA Drug
Yes

Countries

  • Malawi
  • South Africa
  • Uganda
  • Zimbabwe

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 NCT03386578 on ClinicalTrials.gov