CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 10 enrolled
Drug / intervention
TDF IVR +2 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/NCT02431273
NCT02431273Early Ph 1Completed
CompareCT.gov

Open-Label Safety and Pharmacokinetic Study of Single (TDF), Dual (TDF-FTC), and Triple ARV IVR (TDF-FTC-MVC) in Healthy Women

Auritec Pharmaceuticals·interventional·Posted May 1, 2015·Updated Jul 2, 2019

In Brief

A Early Phase 1 clinical trial evaluating TDF IVR, TDF-FTC IVR, and 1 other intervention for Human Immunodeficiency Virus (HIV) Prophylaxis. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC ("Triple" IVR). TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus (HIV) Prophylaxis
CountriesUnited States
CollaboratorsThe University of Texas Medical Branch, Galveston, Oak Crest Institute of Science, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Early Ph 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 1, 2015
Enrollment StartJun 1, 2015
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.2 years ago

Interventions

TDF IVRdrug

TDF-FTC IVRdrug

TDF-FTC-MVC IVRdrug