RT Journal Article
SR Electronic
T1 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
JF Sexually Transmitted Infections
JO Sex Transm Infect
FD BMJ Publishing Group Ltd
SP 363
OP 369
DO 10.1136/sextrans-2014-051537
VO 90
IS 5
A1 M Bradford Guffey
A1 Barbra Richardson
A1 Marla Husnik
A1 Bonus Makanani
A1 David Chilongozi
A1 Elmer Yu
A1 Gita Ramjee
A1 Nyaradzo Mgodi
A1 Kailazarid Gomez
A1 Sharon L Hillier
A1 Salim Abdool Karim
A1 on behalf of the HIV Prevention Trials Network (HPTN) 035 Study Team
YR 2014
UL http://sti.bmj.com/content/90/5/363.abstract
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.