title: 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: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT00074425.
authors.affiliation: Departments of Medicine and Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.
authors.forename: M Bradford
authors.initials: MB
authors.lastname: Guffey
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, Washington, USA Department of Biostatistics, University of Washington, Seattle, Washington, USA.
authors.forename: Barbra
authors.initials: B
authors.lastname: Richardson
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
authors.forename: Marla
authors.initials: M
authors.lastname: Husnik
authors.affiliation: Department of Obstetrics and Gynaecology, University of Malawi College of Medicine, Blantyre, Malawi.
authors.forename: Bonus
authors.initials: B
authors.lastname: Makanani
authors.affiliation: University of North Carolina Project, Lilongwe, Malawi.
authors.forename: David
authors.initials: D
authors.lastname: Chilongozi
authors.affiliation: Department of Psychiatry, University of Pennsylvania, Philadelphia, Pensylvania, USA.
authors.forename: Elmer
authors.initials: E
authors.lastname: Yu
authors.affiliation: HIV Prevention Research Unit, South African Medical Research Council, Durban, KwaZulu-Natal, South Africa.
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
authors.affiliation: Department of Obstetrics and Gynaecology, University of Zimbabwe-University of California San Francisco Collaborative Research Programme, Belgravia, Harare, Zimbabwe.
authors.forename: Nyaradzo
authors.initials: N
authors.lastname: Mgodi
authors.affiliation: FHI 360, Science Facilitation, Research Triangle Park, North Carolina, USA.
authors.forename: Kailazarid
authors.initials: K
authors.lastname: Gomez
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Hillier
authors.affiliation: University of KwaZulu-Natal, CAPRISA, Durban, KwaZulu-Natal, South Africa.
authors.forename: Salim Abdool
authors.initials: SA
authors.lastname: Karim
mesh_terms: D000180:Acrylic Resins / Q000008:administration & dosage*; D000287:Administration, Topical; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D002690:Chlamydia Infections / Q000188:drug therapy / Q000517:prevention & control*; D017280:Condoms / Q000706:statistics & numerical data; D037001:Directive Counseling / Q000379:methods; D005260:Female; D006069:Gonorrhea / Q000188:drug therapy / Q000517:prevention & control*; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D006293:Health Promotion; D006801:Humans; D008295:Malawi; D009282:Naphthalenesulfonates / Q000008:administration & dosage*; D011108:Polymers / Q000008:administration & dosage*; D040242:Risk Reduction Behavior; D012725:Sexual Behavior; D013019:South Africa; D016896:Treatment Outcome; D014247:Trichomonas Vaginitis / Q000188:drug therapy / Q000517:prevention & control*; D014481:United States; D014621:Vagina; D015024:Zambia; D015030:Zimbabwe
chemical_list: D000180:Acrylic Resins; D000890:Anti-Infective Agents; C420918:BufferGel; D009282:Naphthalenesulfonates; C120231:PRO 2000; D011108:Polymers
keywords: CHLAMYDIA TRACHOMATIS; MICROBICIDES; NEISSERIA GONORRHOEA; PREVENTION; TRICHOMONAS