MTN 027
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:Blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionThe vicriviroc (MK-4176) IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Mode of DeliveryRing
ARMsExperimental
DescriptionThe MK-2048 IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Mode of DeliveryRing
ARMsExperimental
DescriptionThe MK-2048A IVR will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Mode of DeliveryRing
ARMsExperimental
Official Code:
NCT02356302
Trial Sponsors:
DAIDS-ES: 12014, NICHD, NIH, NIMH, USAID
Start Date
End Date
none
none
Enrollment:48
Age range:
18 Years ↔
45 Years
Population:Cisgender Women