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Exploratory Pharmacodynamic Study of Tenofovir-Based Products

NCT02722343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-09-02

No results posted yet for this study

Summary

This single site study is designed to describe and measure the efficacy of oral versus vaginal dosing of TFV-based products, specifically emtricitabine/tenofovir disoproxil fumarate oral tablets (Truvada) vs tenofovir intravaginal rings (IVR).

Conditions

Interventions

DRUG

Tenofovir intravaginal ring

The participant will wear the intravaginal ring consecutively for 14 days and nights. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)

DRUG

Truvada

The participant will take the tablet for 14 days. taking one tablet each morning. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)

Sponsors & Collaborators

  • Eastern Virginia Medical School

    collaborator OTHER

  • University of North Carolina

    collaborator OTHER

  • Agility Clinical, Inc.

    collaborator INDUSTRY

  • CONRAD

    lead OTHER

Principal Investigators

  • Andrea R Thurman, M.D. · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

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 NCT02722343 on ClinicalTrials.gov