An Exploratory Rectal Safety Study of Three Tenofovir Gel Formulations

Status Completed

Clinical Trial Summary

This is a double-blinded, randomized, pharmacokinetic and safety study of 3 rectally applied tenofovir microbicide formulations: a vaginal formulation (VF), a reduced glycerin vaginal formulation (RGVF), and a rectal-specific formulation (RF). Nine HIV-negative men will be enrolled.

Each participant will receive two inpatient doses of each radiolabeled study product. The first inpatient dose of each product will be administered without coital dynamics simulation (CDS), while the second inpatient dose will be followed by a CDS procedure at 1-hour post dose with instillation of radiolabeled autologous semen. There will be a washout period of at least 11 days between each dose.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

HIV Prevention

Clinical Trial Details

NCT number	NCT01575418
Study type	Interventional
Source	University of Pittsburgh
Contact
Status	Completed
Phase	Phase 1
Start date	March 2013
Completion date	November 2013

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