A Phase 1 study of MK-2048/ Vicriviroc (MK-4176)/
MK 2048A intravaginal rings.
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.