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MTN 001

Status
Completed
Phase
Open Label
Principal Investigator(s)
Craig W. Hendrix
Objective

To determine the adherence acceptability to and blood levels of three daily regimens of tenofovir in both oral and gel form.

 

Results:Compared to oral dosing, vaginal dosing achieved much lower serum concentrations and much higher vaginal tissue concentrations. Even allowing for 100-fold concentration differences due to poor adherence or less frequent prescribed dosing, vaginal dosing of tenofovir should provide higher active site concentrations and theoretically greater PrEP efficacy than oral dosing; randomized topical dosing PrEP trials to the contrary indicates that factors beyond tenofovir's antiviral effect substantially influence PrEP efficacy.

Prevention Option(s)
Microbicides
Study Design
Open label
Arms and Assigned Interventions
Description
Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20
Mode of Delivery
Gel
Tablet
Products
1% tenofovir gel
TDF
ARMs
Experimental
Trial Sponsors
NIAID, MTN, CONRAD, Gilead
June 2008
July 2010
Enrollment
168
18
Years
45
Years
Population
Women
Sites

Bronx-Lebanon Hospital

New York, New York
United States of America

Case CRS

Cleveland, Ohio
United States of America

Botha's Hill CRS

Westville, KwaZulu-Natal
South Africa

Umkomaas CRS

Umkomaas, KwaZulu-Natal
South Africa

Makerere University - Johns Hopkins University Research Collaboration

Kampala
Uganda

Alabama Microbicide CRS

Birmingham, Alabama
United States of America

Bronx- Lebanon Hospital Center Clinical Research Site

Bronx, New York
United States of America

Pitt CRS

Pittsburgh, Pennsylvania
United States of America