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Status
Completed
Phase
I
Principal Investigator(s)
Albert Liu, MD, MPH
Objective
Intravaginal rings (IVRs) may offer an ideal way to deliver antiretroviral (ARV) drugs to prevent HIV infection. This study will evaluate the pharmacokinetics and safety of two IVRs containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176) and MK-2048, in healthy, HIV-uninfected women.
*Closed to follow-up as of 3/22/16*
Last updated May 16, 2021
Prevention Option(s)
Microbicides
Study Design
Randomized
Blind
Arms and Assigned Interventions
Description
The MK-2048A IVR (Low Dose) will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Contains 91 mg of vicriviroc (MK-4176) and 10 mg of MK-2048.
Mode of Delivery
Ring
Products
Vicriviroc
ARMs
Experimental
Description
The MK-2048A IVR (Original Dose) will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Contains 182 mg of vicriviroc (MK-4176) and 30 mg of MK-2048.
Products
Vicriviroc
ARMs
Experimental
Official Code
Trial Sponsors
NIAID (DAIDS-ES: 12022) , NICHD, NIMH, NIH
June 2015
March 2016
Enrollment
19
18
Years
45
Years
Population
Women
Sites
Bridge HIV CRS
San Francisco, California
United States of America