M Bradford Guffey1, Barbra Richardson2, Marla Husnik3, Bonus Makanani4, David Chilongozi5, Elmer Yu6, Gita Ramjee7, Nyaradzo Mgodi8, Kailazarid Gomez9, Sharon L Hillier10, Salim Abdool Karim11. 1. Departments of Medicine and Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA Centre for Infectious Disease Research in Zambia, Lusaka, Zambia. 2. Fred Hutchinson Cancer Research Center, Seattle, Washington, USA Department of Biostatistics, University of Washington, Seattle, Washington, USA. 3. Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. 4. Department of Obstetrics and Gynaecology, University of Malawi College of Medicine, Blantyre, Malawi. 5. University of North Carolina Project, Lilongwe, Malawi. 6. Department of Psychiatry, University of Pennsylvania, Philadelphia, Pensylvania, USA. 7. HIV Prevention Research Unit, South African Medical Research Council, Durban, KwaZulu-Natal, South Africa. 8. Department of Obstetrics and Gynaecology, University of Zimbabwe-University of California San Francisco Collaborative Research Programme, Belgravia, Harare, Zimbabwe. 9. FHI 360, Science Facilitation, Research Triangle Park, North Carolina, USA. 10. Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. 11. University of KwaZulu-Natal, CAPRISA, Durban, KwaZulu-Natal, South Africa.
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 thesafety 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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: L Zeitlin; T E Hoen; S L Achilles; T A Hegarty; A E Jerse; J W Kreider; S S Olmsted; K J Whaley; R A Cone; T R Moench Journal: Sex Transm Dis Date: 2001-07 Impact factor: 2.830
Authors: Salim S Abdool Karim; Barbra A Richardson; Gita Ramjee; Irving F Hoffman; Zvavahera M Chirenje; Taha Taha; Muzala Kapina; Lisa Maslankowski; Anne Coletti; Albert Profy; Thomas R Moench; Estelle Piwowar-Manning; Benoît Mâsse; Sharon L Hillier; Lydia Soto-Torres Journal: AIDS Date: 2011-04-24 Impact factor: 4.177
Authors: Elisabeth M van der Elst; Haile Selassie Okuku; Phellister Nakamya; Allan Muhaari; Alun Davies; R Scott McClelland; Matthew A Price; Adrian D Smith; Susan M Graham; Eduard J Sanders Journal: PLoS One Date: 2009-05-01 Impact factor: 3.240
Authors: Z Mike Chirenje; Nicholas Dhibi; H Hunter Handsfield; Elizabeth Gonese; Beth Tippett Barr; Lovemore Gwanzura; Ahmed S Latif; Dumisili Venessa Maseko; Ranmini S Kularatne; Mufuta Tshimanga; Peter H Kilmarx; Anna Machiha; Owen Mugurungi; Cornelis A Rietmeijer Journal: Sex Transm Dis Date: 2018-06 Impact factor: 2.830
Authors: José A Fernández-Romero; Carolyn Deal; Betsy C Herold; John Schiller; Dorothy Patton; Thomas Zydowsky; Joe Romano; Christopher D Petro; Manjulaa Narasimhan Journal: Trends Microbiol Date: 2015-03-07 Impact factor: 17.079
Authors: Peter A Anton; Terry Saunders; Julie Elliott; Elena Khanukhova; Robert Dennis; Amy Adler; Galen Cortina; Karen Tanner; John Boscardin; William G Cumberland; Ying Zhou; Ana Ventuneac; Alex Carballo-Diéguez; Lorna Rabe; Timothy McCormick; Henry Gabelnick; Christine Mauck; Ian McGowan Journal: PLoS One Date: 2011-09-28 Impact factor: 3.240
Authors: Dobromir Dimitrov; Marie-Claude Boily; Jeannie Marrazzo; Richard Beigi; Elizabeth R Brown Journal: PLoS One Date: 2013-09-16 Impact factor: 3.240