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
DescriptionOral 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 DeliveryGel, Tablet
ARMsExperimental
Results: MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments.
Official Code: NCT00592124
Trial Sponsors: CONRAD, Gilead, MTN, NIAID
Start Date
End Date
June 30, 2008
July 31, 2010
Enrollment:168
Age range: 18 Years ↔ 45 Years
Population:Cisgender Women