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MTN 014

Status
Completed
Phase
I
Principal Investigator(s)
Gonasagrie Nair
Objective

To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin 1% gel after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use.

Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Reformulated rectal 1% tenofovir gel
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
Reformulated vaginal 1% tenofovir gel
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Trial Sponsors
CONRAD, MTN, NIAID, NIMH
October 2012
December 2014
Enrollment
14
21
Years
45
Years
Population
Women
Sites

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal
South Africa

Center for Infectious Disease Epidemiologic Research, Mailman School of Public Health

New York, New York
United States of America