Roxana Rustomjee|Salim S. Abdool Karim|Salim S. Abdool Karim|Marie Laga|Zena Stein
Phase 1 trial of nonoxynol-9 film among sex workers in South Africa
University of KwaZulu-Natal|South African Medical Research Council|South African Medical Research Council|University of KwaZulu-Natal|Columbia University|South African Medical Research Council|Instituut voor Tropische Geneeskunde|Columbia University
assess acceptability safety vaginal nonoxynol9 film group sex workers truck stop south africaa randomized doubleblinded crossover trial conducted april 1995 july 1995seventytwo mg nonoxynol9 film identical glycerine placebo filmfollowing informed consent study participant randomly assigned designated precoded film 1 month second month filmfree washout period participants used alternate film third month besides measuring behavioural clinical outcomes colposcopy examination genital lesions serology microbiology investigations sexually transmitted diseases semiquantitative pcr vaginal hiv load estimates performedtwenty women participated study women reported average 19 sexual encounters per week vaginal intercourse protected 25 time condoms average 11 vaginal films either nonoxynol9 placebos inserted per week statistically significant differences two treatment groups genital lesions p 029 reported side effects p 073 viral load p 09 however proportions clinically detected genital lesions six eight versus two eight selfreported sideeffects five eight versus three eight higher nonoxynol9 group compared placebo group incident sexually transmitted diseases occurred frequently placebo group increased viral load associated development genital lesion relative risk 60 95 confidence interval 081444the 72 mg film formulation nonoxynol9 acceptable product use population sex workers although statistically significant differences adverse outcomes detected clinically appeared increase minor lesions selfreported sideeffects nonoxynol9 less protection sexually transmitted diseases placebo furthermore hiv shedding correlated presence incident vaginal cervical lesions brings question potential narrow margin safety product additional phase 2 studies therefore required