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Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1

NCT06435026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-02-17

No results posted yet for this study

Summary

This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy based on drug pharmacokinetics, and (2) evaluate the maternal and infant safety of increased FTC/TDF doses during these periods.

Conditions

  • HIV
  • Prevention
  • Pregnancy

Interventions

DRUG

FTC/TDF 200mg/300mg

Standard Dose

DRUG

FTC/TDF 300mg/450mg

150% Standard Dose

DRUG

FTC/TDF 400mg/600mg

200% Standard Dose

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

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

  • Lynda Stranix-Chibanda, MBChB, MMed · University of Zimbabwe

  • Peter Anderson, PharmD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2026-02-11
Completion
2026-02-11
FDA Drug
Yes

Countries

  • Malawi
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

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 NCT06435026 on ClinicalTrials.gov