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MTN-027 was a multi-site, single-blind, four-arm, randomized, placebo-controlled Phase 1 safety and PK trial of the vicriviroc (MK-4176) IVR, containing 182 mg vicriviroc (MK-4176); the MK-2048 IVR, containing 30 mg MK-2048; the MK-2048A IVR, containing 182 mg vicriviroc (MK-4176) and 30 mg MK-2048; and the Placebo VR. The combination IVR (MK-2048A IVR) combines two different classes of antiretroviral agents - a CCR5-receptor antagonist, VCV (MK-4176), with an integrase inhibitor, MK-2048. The study enrolled 48 healthy women aged 18-45 who were HIV-uninfected, non-pregnant, sexually abstinent, and using adequate contraception. Women were randomized to one of four study regimens in a 1:1:1:1 ratio. The IVR was used continuously for approximately 28 consecutive days. The design of MTN-027 allowed for safety comparisons of each study product to a placebo and provided data on relative safety among active products.  Additionally, data related to the absorption and distribution of the drug(s) were collected.

MTN-027 and MTN-028 were the first clinical trials to test an integrase inhibitor as a microbicide. MTN-027 completed follow-up on March 7, 2016. The primary manuscript was published in Clinical Infectious Diseases on March 19, 2019, along with the primary results manuscript for Protocol MTN-028.

Protocol Chair(s)
Hoesley, Craig (Protocol Chair)
Protocol Title
Phase 1 Safety and Pharmacokinetics Study of MK-2048/Vicriviroc (MK-4176)/MK 2048A Intravaginal Rings
DAIDS Protocol ID
Vaginal Ring
Vicriviroc (MK‐4176)  
Study Focus/Product Administration
Study Type
Study Phase
Phase I  
United States
Women (cisgender women, non‐transgender women)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Other Study Info

Phase I, multi-site, four-arm, randomized (1:1:1:1), single-blind, placebo-controlled trial