CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 73 enrolled
Drug / intervention
TDF +3 moredrug
Likely dose
TDF 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01448616
NCT01448616Phase 4Completed
CompareCT.gov

Effect of Tenofovir on Genital HSV Shedding: a Randomized, Double-blind, Placebo-controlled Clinical Trial

University of Washington·interventional·Posted Oct 7, 2011·Updated Feb 16, 2023

In Brief

A Phase 4 clinical trial evaluating TDF, Placebo Vaginal Gel, and 2 other interventions for Herpes Simplex Type II. Completed, enrolled 73 participants across 1 site.

Detailed Summary

The investigators propose a randomized, double blind, placebo-controlled, cross-over trial to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir will reduce genital HSV shedding compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Simplex Type II
CountriesUnited States
CollaboratorsCONRAD, Gilead Sciences

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2011
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.7 years ago

Interventions

TDFdrug

Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.

Placebo Vaginal Geldrug

Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible. The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects - negative or positive - on study endpoints.

Vaginal TFV Geldrug

Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.

Placebo Tabletsdrug

TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.