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

HIV/AIDS Clinical Trial

Official title:
CHARM-03: A Randomized, Open Label, Crossover Phase 1 Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel Administered Rectally and Vaginally to HIV-1 Seronegative Adults

Clinical Trial 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.

Clinical Trial Description

Trail 11991 is a Phase 1 randomized, open label, single-site trial. Approximately 19 participants (9 female, 10 male) will be randomized to the 9 female study arms and 4 male study arms with 1-3 participants per arm. The randomization will be completed for the product sequence and the timing of tissue sample collection.

All participants will receive both study products by multiple routes of administration (i.e., PO, PR, [and PV for female participants]), and they will be randomized to the order of product sequence and specimen sampling schedule. The male participants will receive oral and rectal MVC and the female participants will receive oral, rectal, and vaginal MVC, in randomized sequence.

Participant accrual will take approximately 6 months. Male participants will be on study for approximately 9 to 12 weeks. Female participants will be on study for approximately 12 to 16 weeks. The total duration of the study will be approximately 9 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02346084
Study type Interventional
Source International Partnership for Microbicides, Inc.
Contact
Status Completed
Phase Phase 1
Start date January 2015
Completion date March 2016
View Details
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