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Pharmacokinetics of Two Intravaginal Rings (IVRs) Containing Different Dose Strengths of Vicriviroc (MK-4176) and MK-2048

NCT02419456 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-11-11

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

MK-2048A IVR (Low Dose)

Contains 91 mg of vicriviroc (MK-4176) and 10 mg of MK-2048.

DRUG

MK-2048A IVR (Original Dose)

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Albert Liu, MD, MPH · San Francisco Department of Public Health

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
2015-06-30
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 NCT02419456 on ClinicalTrials.gov