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

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

March 31, 2016

Conditions
HIV/AIDS
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)."

Trial Locations (1)

15213

Magee Women's Hospital of UPMC, Pittsburgh

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

International Partnership for Microbicides, Inc.

INDUSTRY

NCT02346084 - Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults | Biotech Hunter | Biotech Hunter