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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 enrolled 48 healthy, 18-45 year old women 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 is worn for approximately 28 consecutive days.

The design of MTN-027 will allow safety comparisons of each study product to a placebo and may provide data on relative safety among active products.  Additionally, data related to the absorption and distribution of the drug(s) will be collected.

MTN-027 and MTN-028 are the first clinical trials to test an integrase inhibitor as a microbicide.

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
12014
Status
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
MK‐2048
Vicriviroc (MK‐4176)  
Study Focus/Product Administration
Vaginal
Study Type
Pharmacokinetics
Safety
Study Phase
Phase I  
Countries
United States
Population
Women (cisgender women, non‐transgender women)
Funder(s)
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
Sponsor(s)
DAIDS
Other Study Info

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