Funding Source and Project Period: DAIDS, NIAID, USNIH, 2009-2010

Key Personnel:
Principal Investigator: Dr. Peter Anton
Co-investigator: Dr. Alex Carballo-Diéguez

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Project Overview:


Receptive anal intercourse (RAI) is common among men who have sex with men (MSM) and there is increasing evidence that heterosexual women in the developed and developing world also practice anal sex. It can therefore be anticipated that once vaginal microbicides are licensed, they will be used in both the vaginal and rectal compartments. As a consequence, there is a need to evaluate both the rectal and vaginal safety profile of candidate microbicides. This clinical trial is being conducted to evaluate the safety and acceptability of the candidate microbicide, 1% vaginally-formulated tenofovir gel, when applied rectally in men and women compared to an oral dose of 300 mg tenofovir tablet and a placebo gel (Hydroxyethyl cellulose [HEC] placebo gel

The study is being conducted with 18 HIV-uninfected sexually (rectal and vaginal) abstinent men and women recruited at two MTN study sites (UCLA Center for Prevention Research, Los Angeles, CA and University of Pittsburgh Medical Center, Pittsburgh, PA). Participants are 18 years of age or older. All of the participants are asked to take a tablet orally, and then they are randomized to receive either the gel with the active microbicide or a placebo gel. The study gel (either active or placebo) will be administered once in the clinic, and after two weeks, it will self-administered by participants once per day during seven consecutive days.


The primary objective is to evaluate the systemic safety of 1% vaginally-formulated tenofovir gel applied rectally. The main behavioral objective is to evaluate product acceptability by means of a behavioral assessment that includes both quantitative and qualitative methods. This assessment, administered to all (placebo and drug-exposed) participants, will evaluate not only product acceptability, but also the acceptability of a vaginal applicator for rectal product application. The behavioral assessment consists of three elements: 1) a Baseline Behavioral Questionnaire 2) a Product Acceptability Questionnaire, and 3) an in-depth phone interview. The quantitative data will be primarily descriptive of demographic variables, sexual behavior in the prior three months, lubricant and enema use, frequency of HIV testing, and substance use in the prior three months, and will provide descriptive statistics of acceptability.


To evaluate the acceptability of tenofovir 1% gel when applied rectally, the secondary endpoint is to examine the proportion of participants who at their Final Clinic Visit report that they would be very likely to use the candidate microbicide during receptive anal intercourse. The qualitative data will serve to contextualize participants’ ratings of acceptability. Ultimately, the qualitative and quantitative data will be integrated with the purpose of creating a full-fledged picture of the different factors affecting acceptability. This study is currently recruiting participants.