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.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health
Phase I, multi-site, four-arm, randomized (1:1:1:1), single-blind, placebo-controlled trial