PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 20, 2018

Primary Completion Date

September 30, 2020

Study Completion Date

December 31, 2025

Conditions
HIV Prevention
Interventions
DRUG

Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC)

TDF-FTC pod-IVR designed to deliver TDF at a target rate of 1 mg d-1 and FTC at a target rate of 2 mg d-1.

OTHER

Placebo

A placebo pod-IVR containing microcrystalline cellulose pods.

Trial Locations (1)

77555

University of Texas Medical Branch, Galveston

All Listed Sponsors
collaborator

The Miriam Hospital

OTHER

collaborator

Johns Hopkins University

OTHER

collaborator

University of California, Los Angeles

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

Vanderbilt University

OTHER

collaborator

The University of Texas Medical Branch, Galveston

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Oak Crest Institute of Science

OTHER