CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
Once Daily Application of TFV RG 1% Gel - Vaginal +3 moredrug
Likely dose
Not stated in 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/NCT01768962
NCT01768962Phase 1Completed
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A Phase 1 Crossover Trial Evaluating the Pharmacokinetics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women

CONRAD·interventional·Posted Jan 16, 2013·Updated Jun 28, 2021

In Brief

A Phase 1 clinical trial evaluating Once Daily Application of TFV RG 1% Gel - Vaginal and Once Daily Application of TFV RG 1% gel - Rectal for HIV Prevention. Completed, enrolled 14 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Prevention
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2013
Enrollment StartApr 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.5 years ago

Interventions

Once Daily Application of TFV RG 1% Gel - Vaginaldrug

Vaginal application

Once Daily Application of TFV RG 1% gel - Rectaldrug

Rectal application

Once Daily Application of TFV RG 1% gel - Rectaldrug

Rectal application

Once Daily Application of TFV RG 1% Gel - Vaginaldrug

Vaginal application