Microbicide Trials Network

MTN-027

Details

Protocol Title: 
Phase 1 Safety and Pharmacokinetics Study of MK-2048/Vicriviroc (MK-4176)/MK 2048A Intravaginal Rings
DAIDS Protocol ID: 
12014
Status: 
Closed to Follow Up

Protocol Chair(s)

Craig Hoesley (Protocol Chair)

Description

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.

 

Other Study Info

Sponsors:

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 

Co-Sponsors:

DAIDS 

Study Design:

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