AEGiS-14IAC: Phase I clinical trial to evaluate the safety, tolerance and acceptability of the invisible condomÃ‚Â® when applied intravaginally to healthy female subjects.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Phase I clinical trial to evaluate the safety, tolerance and acceptability of the invisible condom é « when applied intravaginally to healthy female subjects.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. LbPp2212)

Trottier S, Omar R, Desormeaux A, Gagnon MT, Vezina F, Guilbert E, Bergeron M
Hospital/University, Quebec, Canada

BACKGROUND: We have developed a topical microbicide gel formulation containing sodium lauryl sulfate (SLS), called the Invisible Condom é « that can provide both a physical and a chemical barrier to prevent STDs including HIV/AIDS. We showed that SLS is a potent inhibitor of various HIV and HSV strains. We also showed that vaginal pretreatment of mice with the gel containing SLS completely protected animals against the lethal vaginal HSV-2 infection and that the gel was well tolerated after repeated vaginal applications to rabbits.

METHODS: We have conducted phase I clinical trial to evaluate the safety & acceptability of the Invisible Condom é « when applied vaginally once or twice daily for 14 days to healthy female subjects and their male sexual partners, when applicable. All 47 female subjects and 23 male sexual partners completed product exposure. Women were divided into 3 groups: sexually abstinent, sexually active with tubal ligation, and on oral contraceptive. An applicator specifically designed to distribute the gel uniformly throughout the vagina and cervix was used. Nugent score, pH, general & genital adverse events were evaluated. Gynecologic and colposcopic examinations were done at baseline and after the last gel application.

RESULTS: The gel persisted 4 to 8 hours after its vaginal application. Vaginal flora were not significantly altered as assessed by Nugent score. The vaginal pH did not change over the product exposure period (pH before, during and after gel applications ranged from 4.4 to 5.4). Minor symptoms (mild or moderate) possibly related to the product use were observed in about one third of subjects. The most common events were erythema, itching, burning sensation, vaginal discharge and vaginal dryness. No genital ulceration or lesions were seen during gel use.

CONCLUSION: Both the gel formulation and the applicator were acceptable by most of the subjects. The Invisible Condom é « was found to be generally well tolerated.

Keywords: AEGIS, Clinical Trials, HIV Infections, Safety, Anti-Infective Agents, Gels, Vagina, Spermatocidal Agents, Herpesvirus 2, Human, Sodium Dodecyl Sulfate, Anti-Infective Agents, Local, Human, Female, Male, Animal, Mice, Rabbits

020707
LbPp2212