MTN 028
Status:Completed
Phase:I
Principal Investigator(s):Albert Liu, MD, MPH
Objective:Intravaginal rings (IVRs) may offer an ideal way to deliver antiretroviral (ARV) drugs to prevent HIV infection. This study will evaluate the pharmacokinetics and safety of two IVRs containing different doses of a combination of two HIV ARV drugs, vicriviroc (VCV) (MK-4176) and MK-2048, in healthy, HIV-uninfected women.
*Closed to follow-up as of 3/22/16*
Last updated May 16, 2021
Prevention Option(s):Microbicides
Study Design:Blind, Randomized
Arms and Assigned Interventions
DescriptionThe MK-2048A IVR (Low Dose) will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Contains 91 mg of vicriviroc (MK-4176) and 10 mg of MK-2048.
Mode of DeliveryRing
ARMsExperimental
DescriptionThe MK-2048A IVR (Original Dose) will be inserted during the enrollment visit (Day 0), and it will be removed on Day 28.
Contains 182 mg of vicriviroc (MK-4176) and 30 mg of MK-2048.
Mode of Delivery
ARMsExperimental
Official Code:
NCT02419456
Trial Sponsors:
NIAID (DAIDS-ES: 12022), NICHD, NIH, NIMH
Start Date
End Date
June 1, 2015
March 1, 2016
Enrollment:19
Age range:
18 Years ↔
45 Years
Population:Cisgender Women