A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants
The purpose of this study is to determine the feasibility of a novel method to assess antiretroviral efficacy for protection against HIV-1 infection in vaginal and cervical tissue biopsies.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Feasibility Study to Assess Protection of Vaginal and Cervical Tissues From Ex-Vivo HIV-1 Challenge Following Oral Administration of Maraviroc and Tenofovir|
- Evidence of explant infection [ Time Frame: 2 days post-biopsy ] [ Designated as safety issue: No ]To determine if oral administration of tenofovir plus maraviroc can protect mucosal tissues from HIV infection in an ex-vivo HIV challenge of biopsies collected post-dose.
|Study Start Date:||February 2014|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: All Participants
Maraviroc 600 mg + Tenofovir 600 mg
Other Names:Drug: Maraviroc
Other Name: Selzentry
Participants: Six premenopausal healthy volunteer women between 18-49 years of age with an intact uterus and cervix.
Procedures (methods): Subjects will be given a single dose of two oral antiretrovirals (maraviroc 600mg/tenofovir 600 mg). Subjects will be monitored and assessed for adverse events post-dose. Subjects will be sent home and asked to return in 24 hours. 24 hours post-dose, two vaginal and two cervical biopsies will be obtained. These biopsies will then be placed in an ex-vivo culture system and exposed to HIV. Viral RNA will be measured over two days to determine whether the tissues were protected from infection. A final visit for safety will be conducted 7-14 days post-enrollment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039323
|United States, North Carolina|
|CTRC University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Angela DM Kashuba, PharmD||UNC at Chapel hill|