A Study to Compare Three Different Formulations of Tenofovir 1% Gel When

Status Completed

Clinical Trial Summary

This is a double-blinded, randomized, safety, acceptability, pharmacokinetic, and ex vivo efficacy study of three rectally-applied tenofovir-based microbicide formulations. Approximately 18 total evaluable HIV-negative men and women (~9 per site) will be enrolled across two study sites: University of California at Los Angeles (UCLA) and Magee-Womens Research Institute (MWRI) at University of Pittsburgh.

Each participant will experience seven rectal exposures to the rectal-specific formulation (RF) and seven rectal exposures to the reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel, but only one exposure to the vaginal formulation (VF), which will be coupled with six preceding exposures to the Universal HEC Placebo Gel to balance out the VF study stage. Participant accrual will take approximately 6 months and each participant will be on study for approximately 3 months. The total duration of the study will be approximately 1 year.

The primary objectives of the study are safety, acceptability, and pharmacokinetics, specifically:

- To evaluate the safety of each tenofovir-based microbicide gel formulation when applied rectally

- To evaluate the acceptability of each tenofovir-based microbicide gel formulation when applied rectally

- To compare systemic and compartment pharmacokinetics among the three tenofovir-based microbicide gel formulations when applied rectally

Secondary objective of the study is to evaluate the mucosal immunotoxicity of each tenofovir-based microbicide gel formulation when applied rectally.

And the exploratory objective of the study is to assess the preliminary (ex vivo) efficacy of each tenofovir-based microbicide gel formulation using biopsy explants after each product is applied rectally.

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	NCT01575405
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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study to Compare Three Different Formulations of Tenofovir 1% Gel When Administered Rectally

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms