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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.
Sex Transm Infect. 2014 Aug; 90(5):363-9.ST

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 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.

Authors+Show Affiliations

Departments of Medicine and Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.Fred Hutchinson Cancer Research Center, Seattle, Washington, USA Department of Biostatistics, University of Washington, Seattle, Washington, USA.Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.Department of Obstetrics and Gynaecology, University of Malawi College of Medicine, Blantyre, Malawi.University of North Carolina Project, Lilongwe, Malawi.Department of Psychiatry, University of Pennsylvania, Philadelphia, Pensylvania, USA.HIV Prevention Research Unit, South African Medical Research Council, Durban, KwaZulu-Natal, South Africa.Department of Obstetrics and Gynaecology, University of Zimbabwe-University of California San Francisco Collaborative Research Programme, Belgravia, Harare, Zimbabwe.FHI 360, Science Facilitation, Research Triangle Park, North Carolina, USA.Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.University of KwaZulu-Natal, CAPRISA, Durban, KwaZulu-Natal, South Africa.No affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

24898857

Citation

Guffey, M Bradford, et al. "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." Sexually Transmitted Infections, vol. 90, no. 5, 2014, pp. 363-9.
Guffey MB, Richardson B, Husnik M, et al. 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. Sex Transm Infect. 2014;90(5):363-9.
Guffey, M. B., Richardson, B., Husnik, M., Makanani, B., Chilongozi, D., Yu, E., Ramjee, G., Mgodi, N., Gomez, K., Hillier, S. L., & Karim, S. A. (2014). 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. Sexually Transmitted Infections, 90(5), 363-9. https://doi.org/10.1136/sextrans-2014-051537
Guffey MB, et al. 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. Sex Transm Infect. 2014;90(5):363-9. PubMed PMID: 24898857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR 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. AU - Guffey,M Bradford, AU - Richardson,Barbra, AU - Husnik,Marla, AU - Makanani,Bonus, AU - Chilongozi,David, AU - Yu,Elmer, AU - Ramjee,Gita, AU - Mgodi,Nyaradzo, AU - Gomez,Kailazarid, AU - Hillier,Sharon L, AU - Karim,Salim Abdool, AU - ,, Y1 - 2014/06/04/ PY - 2014/6/6/entrez PY - 2014/6/6/pubmed PY - 2014/9/12/medline KW - CHLAMYDIA TRACHOMATIS KW - MICROBICIDES KW - NEISSERIA GONORRHOEA KW - PREVENTION KW - TRICHOMONAS SP - 363 EP - 9 JF - Sexually transmitted infections JO - Sex Transm Infect VL - 90 IS - 5 N2 - 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. SN - 1472-3263 UR - https://www.unboundmedicine.com/medline/citation/24898857/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_ L2 - https://sti.bmj.com/lookup/pmidlookup?view=long&pmid=24898857 DB - PRIME DP - Unbound Medicine ER -