SAFETY EVALUATION OF NONOXYNOL-9 GEL IN WOMEN AT LOW-RISK OF HIV-INFECTION

Objective: To determine the safety of a vaginal microbicide, COL-1492, containing 52.5 mg nonoxynol-9, applied once daily for 14 days among healthy volunteers. Methods: A randomized, double-blind controlled tri al with three arms, COL-1492 gel versus placebo gel versus no-treatmen t controls, was conducted. Outcomes of interest were reported genital symptoms, incidence of gynaecological signs, and incidence of genital lesions revealed by colposcopy. Participants were enrolled in four cen tres (Belgium, The Netherlands, and two in Thailand). Results: A total of 534 women participated in the study: 179 used COL-1492, 178 used p lacebo, and 177 were no-treatment controls. Study visits were schedule d 1 week prior to enrolment (day -7), day 0 (enrolment), day 8 and day 14. The most frequently reported genital symptom was vaginal discharg e in both the COL-1492 and placebo groups. This appeared to be related to leakage of the product out of the vagina. The incidence of lesions associated with epithelial disruption (ulcers and abrasions) was very low (< 2%) and there was no statistically significant difference betw een the three groups. Of the lesions observed by colposcopy that did n ot involve epithelial disruption, petechial haemorrhage was the most f requently detected, with an incidence of 20.1, 9.0 and 7.3% in the COL -1492, placebo and control groups, respectively. COL-1492 users had a higher incidence of erythema (8.4 versus 2% in the other groups). Conc lusion: COL-1492 showed minimal toxicity when applied once daily. A Ph ase III trial to assess the product's effectiveness in HIV prevention is currently ongoing. (C) 1998 Rapid Science Ltd.