At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 86 enrolled
Drug / intervention
Truvada +1 moredrug
Likely dose
Truvada 200 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.
Defining the Rectal Mucosa in Men Who Have Sex With Men at Risk of HIV Infection
In Brief
A Phase 4 clinical trial evaluating Truvada and Gel lubricant for HIV. Completed, enrolled 86 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether the use of rectal lubricants can affect how well the medication, Truvada, will work to prevent infection with HIV when someone is exposed to HIV in the rectum.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedMar 2015
Primary CompletionJan 2017
TodayJul 2026
First PostedMar 27, 2015
Enrollment StartMar 1, 2015
Primary CompletionJan 25, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.3 years ago
Interventions
Truvadadrug
Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
Gel lubricantdevice
Five ml of an over the counter sexual lubricant will be dispensed using an applicator.