Marie Laga

Safety of multiple daily applications of COL-1492, a nonoxynol-9 vaginal gel, among female sex workers

RationaleCOL-1492 is a nonoxynol-9 (N-9)-containing vaginal gel and may be a potential microbicide. As part of an effectiveness trial, an initial toxicity study was conducted. ObjectivesThe main objective of the reported study was the assessment of the toxicity of a 52.5 mg N-9 gel, COL-1492, when used a number of times each day by female sex workers. MethodsThis was a randomized, placebo-controlled triple-blinded trial among female sex workers. The participants were asked to use the product for each vaginal sexual act. At each monthly visit a gynaecological examination with sexually transmitted disease sampling and colposcopy was performed. Venous blood was drawn for syphilis and HIV serology. All women received intensive counselling on condom use. Male condoms and sexually transmitted disease treatment were given free of charge. ResultsOnly blinded results on the colposcopic examinations are reported. The incidence of lesions with or without an epithelial disruption was low: 0.06 and 0.29, respectively, per 100 woman–days in group A; 0.09 and 0.26 respectively per 100 woman–days in group B. There was no significant difference between the two arms. ConclusionThe multiple daily use of COL-1492 by female sex workers did not show an increase of local toxicity over that of a placebo. Colposcopy was discontinued in the autumn of 1997 in accordance with a Data Safety Monitoring Board decision. In the currently ongoing effectiveness trial the assessment of the products toxicity continues to be monitored by simple visual examination.

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 trial with three arms, COL-1492 gel versus placebo gel versus no-treatment 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 centres (Belgium, The Netherlands, and two in Thailand). Results:A total of 534 women participated in the study: 179 used COL-1492, 178 used placebo, and 177 were no-treatment controls. Study visits were scheduled 1 week prior to enrolment (day −7), day 0 (enrolment), day 8 and day 14. The most frequently reported genital symptom was vaginal discharge 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 between the three groups. Of the lesions observed by colposcopy that did not involve epithelial disruption, petechial haemorrhage was the most frequently 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). Conclusion:COL-1492 showed minimal toxicity when applied once daily. A Phase III trial to assess the products effectiveness in HIV prevention is currently ongoing.

Sexually Transmitted Diseases in the Tropics

As is the case for most other infectious diseases, sexually transmitted diseases (STD) are common in many parts of the developing world. This may have multiple causes, such as a larger pool of infected individuals, lack of control programs, antimicrobial resistance of causative organisms, poor health care facilities in general, poor health-seeking behavior, and socioeconomic factors [1]. Table 24.1 shows infection rates of various sexually transmitted agents in pregnant women.