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

Abstract

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 sexually transmitted infections, including Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV). Incidences of STIs were determined by study arm, and hazard ratios (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 GC, 3.9/100 PYAR for CT, and 15.3/100 PYAR for TV. For BufferGel versus placebo gel, HRs were 0.99 (95% CI 0.49–2.00), 1.00 (95% CI 0.64–1.57), and 0.95 (95% CI 0.71–1.25) for prevention of GC, CT, and TV respectively. For PRO 2000, HRs were 1.66 (95% CI 0.90–3.06), 1.16 (95% CI 0.76–1.79), and 1.18 (95% CI 0.90–1.53) for prevention of GC, CT, and TV respectively. Conclusions The incidence of STIs was high during HPTN 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.

How common and frequent is heterosexual anal intercourse among South Africans? A systematic review and meta‐analysis

“…only1[57]2[69,78]3Regional lang. & English17[40,41,43,44,47–49,53,54,56,59–62,73–75]7[40,41,70,76,77,79,80]22 b  Not stated11[42,45,50–52,55,58,63–66]5[46,67,68,71,72]16AI – anal intercourse, VI – vaginal intercourse, UAI – unprotected anal intercourse, UVI – unprotected vaginal intercourse, F – female, M – male, Mix – data available on mixed gender only, FSW – female sex worker, MSM – men who have sex with men, shebeen – an informal establishment serving alcohol, STI – sexually transmitted infection, VCT – voluntary counselling and testing, ACASI – audio computer-assisted self-interview, FTFI – face-to-face interview, SAQ – self-administered questionnaire, CRS – cluster random sample, SRS – simple random sample, RDS – respondent-driven sample, RCT – randomized controlled trial a Studies which reported AI prevalence for unprotected AI only. b Sum lower than expected as two studies report on both higher and general-risk populations. c Recall period referred to here as “general” when participants were asked “Do you practise anal sex”, or similar. d Defined by author as “high risk” but no definition provided; sample consists of 79% FSW [70]. …”

“…The two highest AI prevalence estimates were reported by male school pupils (61.7% and 70.0%) in studies using ACASI [46] and a mixture of ACASI and SAQ [49]. In contrast, the lowest estimates (≤3% over various recall periods) were reported by adult women in FTFI [42,47,50–52,59,65](Figure 1a). Apart from one estimate [81], AI prevalence among higher-risk respondents was consistently high across recall periods (28.4–42.8%) (Figure 1b) and generally higher than for general-risk populations.…”

Multipurpose prevention technologies: the future of HIV and STI protection

“…The HPTN 035 phase II/IIB safety and efficacy study of vaginal microbicides recently evaluated BufferGel and 0.5% PRO 2000 for prevention of T. vaginalis, C. trachomatis and N. gonorrhoeae. Regrettably, neither candidate microbicide had any protective effect against trichomoniasis, chlamydia, or gonorrhea [42]. …”

Новітні Методи Стримування Інфекцій, Що Передаються Статевим Шляхом

“…Також досліджувалися вагінальні мікробіциди, такі як BufferGel і 0,5 % PRO 2000, для профілактики інфікування Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae. На жаль, жоден з кандидатів цих бактерицидних субстанцій не мав достатнього захисного ефекту проти трихомонозу, хламідіозу або гонореї [11]. Відсутність підходящих тварин-моделей для вивчення патогенезу трихомонадної інвазії ускладнювала проведення стандартних досліджень з метою випробовування мікробіцидів.…”