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

NCT03255915 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-03

No results posted yet for this study

Summary

Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC pod-IVR during Stage 3. During Stages 2 \& 3 participants will also complete brief phone surveys (\<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs) regarding perceptibility and acceptability. If willing, participants' male sexual partners will be invited to complete IDIs as well.

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.

Sponsors & Collaborators

  • The Miriam Hospital

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • University of California, Los Angeles

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • Vanderbilt University

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Oak Crest Institute of Science

    lead OTHER

Principal Investigators

  • Kathleen L Vincent, MD · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2020-09-30
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

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 NCT03255915 on ClinicalTrials.gov