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Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults (CHARM-03)

Status
Completed
Phase
I
Principal Investigator(s)
Ian McGowan, MD, PhD, FRCP
Objective

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.

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
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). Other Name: Tablet - Selzentry®, (MVC)
Mode of Delivery
Gel
Tablet
Products
Maraviroc
ARMs
Experimental
Description
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). Other Name: Tablet - Selzentry®, (MVC)
Mode of Delivery
Gel
Tablet
Products
Maraviroc
ARMs
Experimental
Trial Sponsors
IPM, NIAID, NIH
January 2015
March 2016
Enrollment
19
18
Years
45
Years
Population
Women
Men
Sites

Magee Women's Hospital of UPMC

Pittsburgh
United States of America