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Status
Completed
Phase
I
Principal Investigator(s)
Craig Hoesley, MD
Objective
MTN-027 is a multi-site, single-blind, four-arm, randomized, placebo-controlled Phase 1 safety and PK trial of the vicriviroc (MK-4176) VR, containing 182 mg vicriviroc (MK-4176); the MK-2048 VR, containing 30 mg MK-2048; the MK-2048A VR, containing 182 mg vicriviroc (MK-4176) and 30 mg MK-2048; and the Placebo VR. The combination IVR (MK-2048A IVR) is novel as it combines two different classes of antiretroviral agents - a CCR5-receptor antagonist, VCV (MK-4176), with an integrase inhibitor, MK-2048. The study will enroll approximately 48 healthy, 18-45 year old women who are HIV-uninfected, non-pregnant, sexually abstinent, and using adequate contraception. Women will be randomized to one of four study regimens in a 1:1:1:1 ratio. The IVR will be worn for approximately 28 consecutive days.
*Closed to follow-up as of 3/7/16*
Last updated May 16, 2021
Prevention Option(s)
Microbicides
Study Design
Placebo
Randomized
Blind
Arms and Assigned Interventions
Description
The vicriviroc (MK-4176) IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Mode of Delivery
Ring
Products
Vicriviroc
ARMs
Experimental
Description
The MK-2048 IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Mode of Delivery
Ring
Products
Vicriviroc
ARMs
Experimental
Description
The MK-2048A IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Mode of Delivery
Ring
Products
Vicriviroc
ARMs
Experimental
Description
The placebo IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
ARMs
Placebo Comparator
Official Code
Trial Sponsors
USAID, NIMH, NICHD, NIH, DAIDS-ES: 12014
Enrollment
48
18
Years
45
Years
Population
Women
Sites
Alabama Microbicide CRS
Birmingham, Alabama
United States of America
University of Pittsburgh CRS
Pittsburgh, Pennsylvania
United States of America