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Safety and Pharmacokinetics of Intravaginal Rings Containing Vicriviroc (MK-4176) and/or MK-2048

NCT02356302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-10-25

No results posted yet for this study

Summary

Research is currently underway to develop new HIV prevention strategies. Intravaginal rings (IVRs) are one drug delivery method that is currently being studied. This study will evaluate the safety and pharmacokinetics of IVRs containing vicriviroc, MK-2048, and a combination of vicriviroc/MK-2048, in healthy, HIV-uninfected women.

Conditions

  • HIV Infections

Interventions

DEVICE

Vicriviroc (MK-4176) Intravaginal Ring (IVR)

Contains 182 mg vicriviroc (MK-4176).

DEVICE

MK-2048 IVR

Contains 30 mg MK-2048.

DEVICE

MK-2048A IVR

Contains 182 mg vicriviroc (MK-4176) and 30 mg MK-2048.

DEVICE

Placebo IVR

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Craig Hoesley, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02356302 on ClinicalTrials.gov