Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004).

Publication Type:

Journal Article


AIDS (London, England), Volume 25, Issue 8, p.1057-64 (2011)


2011, Administration, Intravaginal, Adolescent, Coitus, Female, Gynecological Examination, Herpesvirus 2, Human, HIV Infections, Humans, Medication Adherence, Patient Satisfaction, Placebos, Polylysine, Treatment Outcome, United States, Vaccine and Infectious Disease Division, Vagina, Vaginal Creams, Foams, and Jellies, Young Adult


The study was designed to assess the safety, adherence, acceptability, and effect on vaginal microflora of 3% SPL7013 Gel (VivaGel), a novel dendrimer topical microbicide that inhibits HIV, herpes simplex virus-2, and human papillomavirus in vitro and in animal models.