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Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women

NCT02431273 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-07-02

Study results available
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Summary

This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC ("Triple" IVR).

TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc

Conditions

  • Human Immunodeficiency Virus (HIV) Prophylaxis

Interventions

DRUG

TDF IVR

DRUG

TDF-FTC IVR

DRUG

TDF-FTC-MVC IVR

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • Oak Crest Institute of Science

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Auritec Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Kathleen L Vincent, MD · University of Texas Medical Branch (UTMB)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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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 NCT02431273 on ClinicalTrials.gov