A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04
Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
CONRAD
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)