A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04

Summary

This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will be randomized to gel or film, tenofovir or placebo. This study will provide additional information in the evaluation of vaginal films containing microbial agents in humans. In addition to safety, the efficacy of these formulations against HIV in an ex vivo biopsy challenge model will be compared.

This study is the first study assessing the safety of tenofovir film in humans. Tenofovir film is formulated in a cellulose based vaginal film containing hydroxypropyl methyl cellulose (HPMC) E5 (5 cp), hydroxyethyl cellulose (HEC), Sodium Carboxymethylcellulose (NaCMC), and glycerin. The excipients of the film have documented safety in other clinical settings.

While the tenofovir film has not been studied extensively in preclinical studies, there are favorable safety data from the macaque study and a substantial body of research with tenofovir gel. It is appropriate to advance the tenofovir film products into a clinical trial for the following reasons:

* No safety concerns were note in the tenofovir film macaque trial.
* The toxicity of tenofovir administered vaginally has been studied extensively. No clinically significant toxicity associated with this route of administration has been observed to date.
* All of the active ingredients of the tenofovir film have been tested in pre-clinical toxicity studies; therefore, the influence of these ingredients on the toxicity profile of tenofovir has been adequately evaluated and has been shown to result in no local or systemic effects.
* The individual components of the tenofovir film have been adequately evaluated and have been shown to be safe.

Conditions

• HIV

Interventions

DRUG

1% vaginally applied tenofovir gel

DRUG

Tenofovir film- 10mg

DRUG

Tenofovir Film-40 mg

OTHER

HEC Placebo Gel

OTHER

Placebo Vaginal Film

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• CONRAD

  lead OTHER

Principal Investigators

• Katherine Bunge, MD · University of Pittsburgh-Magee Womens Hospital of UPMC

• Sharon L Hillier, PhD · University of Pittsburgh-Magee-Womens Hospital of UPMC

Study Design

Allocation

RANDOMIZED

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-11-30

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• United States

Study Locations