NCT02346084

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: International Partnership for Microbicides, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• HIV/AIDS

Interventions

Type	Name	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).

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2015-01-26
• Last updated: 2017-09-08

Locations

1 site across 1 country: United States