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:Open label, Randomized
Arms and Assigned Interventions
DescriptionDrug: 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 DeliveryGel, Tablet
ARMsExperimental
DescriptionDrug: 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 DeliveryGel, Tablet
ARMsExperimental
Official Code:
NCT02346084
Trial Sponsors:
IPM, NIAID, NIH
Start Date
End Date
January 13, 2015
March 13, 2016
Enrollment:19
Age range:
18 Years ↔
45 Years
Population:Cisgender Men, Cisgender Women