An Exploratory, Double-Blinded, Randomized, Pharmacokinetic and Safety Study of Three Rectally-Applied Tenofovir 1% Microbicide Gel Formulations

NCT01575418 Phase 1 COMPLETED

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.

Details

Lead sponsor	Ian McGowan
Phase	Phase 1
Status	COMPLETED
Enrolment	9
Start date	2013-03
Completion	2013-11

Conditions

• HIV Prevention

Interventions

• Rectal formulation (RF) of tenofovir 1% gel
• Vaginal formulation (VF) of tenofovir 1% gel
• Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel
• Radiolabeling of study drugs and semen

Primary outcomes

• Occurrence of adverse events and/or abnormal laboratory values Grade 2 or higher — Participants will be followed for the duration of study, an expected average of 12 weeks
  Grade 2 or higher clinical and laboratory adverse events as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies) will be used to assess safety.

Countries

United States