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The Women TDF-FTC Benchmark Study

NCT05057858 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-08-12

No results posted yet for this study

Summary

The study seeks to define the expected blood levels of pre-exposure prophylaxis (PrEP) medications (tenofovir) for cisgender women taking directly observed oral PrEP therapy to understand the frequency of PrEP dosing associated with HIV protection in cisgender women. Cisgender women will be randomly assigned to receive varying frequency of weekly PrEP doses and followed for up to 16 weeks. The study will also investigate how pregnancy affects the expected blood levels to help define optimal dosing of PrEP for HIV prevention during pregnancy.

Conditions

  • HIV Infections

Interventions

DRUG

co-formulated 300 mg TDF/ 200mg FTC

Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet co-formulated 300 mg TDF/ 200mg FTC

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Kenya Medical Research Institute

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

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

  • Peter L Anderson, PharmD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • Kenya

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 NCT05057858 on ClinicalTrials.gov