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Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults

NCT02346084 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-09-08

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of maraviroc gel following rectal and vaginal administration. The study also includes oral exposure to maraviroc.

Conditions

Interventions

DRUG

Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)

Tablets: daily 300 mg oral maraviroc, Selzentry®,(MVC) for 8 consecutive days Gel: daily rectally administered 1% MVC gel for 8 daily consecutive days Female Participants - will receive an additional third regimen of daily vaginally administered MVC 1% gel for 8 consecutive days. Each treatment regimen will be followed by a washout period of 14 to 21 days. Participants will also be randomized to a biopsy sampling schedule (i.e., D8, D9, or D10 sampling).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • International Partnership for Microbicides, Inc.

    lead INDUSTRY

Principal Investigators

  • Ian McGowan, MD, PhD, FRCP · Magee-Women's Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02346084 on ClinicalTrials.gov