In vitro and ex vivo testing of tenofovir shows it is effective as an HIV-1 microbicide.

Background: Tenofovir gel has entered into clinical trials for use as a topical microbicide to prevent HIV-1 infection but has no published data regarding pre-clinical testing using in vitro and ex vivo models. To validate our findings with on-going clinical trial results, we evaluated topical tenofovir gel for safety and efficacy. We also modeled systemic application of tenofovir for efficacy.

Covert use, vaginal lubrication, and sexual pleasure: a qualitative study of urban U.S. Women in a vaginal microbicide clinical trial.

Using data from a U.S. clinical safety trial of tenofovir gel, a candidate microbicide, we explored the intersection of sexual pleasure and vaginal lubrication to understand whether and under what circumstances women would use a microbicide gel covertly with primary partners.

Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study.

Objectives: In this phase I safety trial of tenofovir gel, a candidate vaginal microbicide for human immunodeficiency virus (HIV) prevention, a mixed-methods design was used to gather acceptability data among women participants. The impact of acceptability factors on use of the gel and the relationship between qualitative and quantitative acceptability data are explored.

Methods: Participants included low-risk, HIV-uninfected, and clinically stable HIV-infected women.

Acceptability of tenofovir gel as a vaginal microbicide by US male participants in a Phase I clinical trial (HPTN 050).

We studied the acceptability of tenofovir gel among HIV-infected and uninfected men who were exposed to it during vaginal intercourse. The gel was found to be highly acceptable to most men, the large majority indicating they would probably use it in the future if they were concerned about HIV and the product were available. Men liked the gel's transparency and odorless qualities, although reactions to its viscosity were more varied.

Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women.

Objectives: Few studies of topical microbicides have assessed their safety in HIV-infected women. We conducted this study to evaluate the safety and acceptability of 6% cellulose sulfate (CS) gel as a vaginal microbicide in sexually abstinent and active HIV-infected women.

Methods: Fifty-nine HIV-infected women were enrolled in a randomized double-blind placebo-controlled study comparing 6% CS to placebo gel used for 14 days.

Phase I safety study of 0.5% PRO 2000 vaginal Gel among HIV un-infected women in Pune, India.

Background: The objective of this study was to evaluate the safety of twice daily, intra-vaginal use of 0.5% PRO 2000 Gel for fourteen days in HIV un-infected women at lower as well as higher risk for HIV acquisition, in Pune, India.

Methods: Forty-two eligible volunteers (30 low-risk and 12 high-risk) were given 0.

Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women.

Objectives: To establish the highest practical dose and frequency (HPDF) of 0.3% or 1% tenofovir vaginal gel applied once or twice daily by sexually abstinent HIV-uninfected women, and to evaluate the safety, tolerability and systemic pharmacokinetics of the HPDF in abstinent and sexually active HIV-negative and HIV-infected women.

Methods: Eighty-four women, enrolled in sequential cohorts, used the study product for 14 consecutive intermenstrual days.

Safety and acceptability of penile application of 2 candidate topical microbicides: BufferGel and PRO 2000 Gel: 3 randomized trials in healthy low-risk men and HIV-positive men.

Objectives: To assess safety and acceptability of penile application of BufferGel (ReProtect, Baltimore, MD) and PRO 2000 Gel (Indevus Pharmaceuticals, Lexington, MA)compared with placebo among low-risk sexually abstinent men and HIV-positive sexually abstinent men.

Design: Seventy-two healthy low-risk men (36 uncircumcised) and 25 HIV-positive men (12 uncircumcised) were enrolled in 3 double-blind, single-center studies as follows: 36 low-risk men in a study of BufferGel and K-Y Jelly (McNeil-PPC, Skillman, NJ) placebo; 36 low-risk men in a study of PRO 2000 Gel and vehicle placebo; and 25 HIV-positive men in a crossover study of BufferGel, PRO 2000 Gel, and K-Y Jelly placebo.

Methods: Participants applied product to the penis on 7 consecutive nights, kept study diaries, and were then interviewed and examined.