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

Status
Completed
Phase
Open Label
Principal Investigator(s)
Kathleen L Vincent, MD
Objective

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).

 

Last updated May 15, 2021

Prevention Option(s)
Microbicides
Study Design
Open label
Arms and Assigned Interventions
Description
All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
Mode of Delivery
Ring
Products
TDF
ARMs
Experimental
Description
If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
Mode of Delivery
Ring
Products
TDF/FTC (Truvada)
ARMs
Experimental
Description
If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
Mode of Delivery
Ring
Products
Maraviroc
TDF/FTC (Truvada)
ARMs
Experimental
Trial Sponsors
Auritec Pharmaceuticals (ARV-IVR 01)
June 2015
December 2016
Enrollment
6
18
Years
45
Years
Sites

University of Texas Medical Branch

Galveston, Texas
United States of America