A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants
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|ClinicalTrials.gov Identifier: NCT02039323|
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : June 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy Adult Females||Drug: Tenofovir Drug: Maraviroc||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Experimental: All Participants
Maraviroc 600 mg + Tenofovir 600 mg
Other Name: Selzentry
- Evidence of explant infection [ Time Frame: 2 days post-biopsy ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|