PT - JOURNAL ARTICLE AU - M Bradford Guffey AU - Barbra Richardson AU - Marla Husnik AU - Bonus Makanani AU - David Chilongozi AU - Elmer Yu AU - Gita Ramjee AU - Nyaradzo Mgodi AU - Kailazarid Gomez AU - Sharon L Hillier AU - Salim Abdool Karim AU - on behalf of the HIV Prevention Trials Network (HPTN) 035 Study Team TI - HPTN 035 phase II/IIb randomised safety and effectiveness study of the vaginal microbicides BufferGel and 0.5% PRO 2000 for the prevention of sexually transmitted infections in women AID - 10.1136/sextrans-2014-051537 DP - 2014 Aug 01 TA - Sexually Transmitted Infections PG - 363--369 VI - 90 IP - 5 4099 - http://sti.bmj.com/content/90/5/363.short 4100 - http://sti.bmj.com/content/90/5/363.full SO - Sex Transm Infect2014 Aug 01; 90 AB - Objectives To estimate the effectiveness of candidate microbicides BufferGel and 0.5% PRO 2000 Gel (P) (PRO 2000) for prevention of non-ulcerative sexually transmitted infections (STIs). Methods Between 2005 and 2007, 3099 women were enrolled in HIV Prevention Trials Network (HPTN) protocol 035, a phase II/IIb evaluation of the safety and effectiveness of BufferGel and PRO 2000 for prevention of STIs, including Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV). Incidences of STIs were determined by study arm, and HRs of BufferGel and PRO 2000 versus placebo gel or no gel control groups were computed using discrete time Andersen-Gill proportional hazards model. Results The overall incidence rates were 1.6/100 person-years at risk (PYAR) for NG, 3.9/100 PYAR for CT and 15.3/100 PYAR for TV. For BufferGel versus placebo gel, HRs were 0.99 (95% CI 0.49 to 2.00), 1.00 (95% CI 0.64 to 1.57) and 0.95 (95% CI 0.71 to 1.25) for prevention of NG, CT and TV, respectively. For PRO 2000, HRs were 1.66 (95% CI 0.90 to 3.06), 1.16 (95% CI 0.76 to 1.79) and 1.18 (95% CI 0.90 to 1.53) for prevention of NG, CT and TV, respectively. Conclusions The incidence of STIs was high during HIV Prevention Trials Network 035 despite provision of free condoms and comprehensive risk-reduction counselling, highlighting the need for effective STI prevention programmes in this population. Unfortunately, candidate microbicides BufferGel and PRO2000 had no protective effect against gonorrhoea, chlamydia or trichomoniasis. Trial registration number NCT00074425.