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Clinical Trial
. 2014 Aug;90(5):363-9.
doi: 10.1136/sextrans-2014-051537. Epub 2014 Jun 4.

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

M Bradford Guffey  1 , Barbra Richardson  2 , Marla Husnik  3 , Bonus Makanani  4 , David Chilongozi  5 , Elmer Yu  6 , Gita Ramjee  7 , Nyaradzo Mgodi  8 , Kailazarid Gomez  9 , Sharon L Hillier  10 , Salim Abdool Karim  11 ; HIV Prevention Trials Network (HPTN) 035 Study Team
Collaborators, Affiliations
Clinical Trial

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

M Bradford Guffey et al. Sex Transm Infect. 2014 Aug.

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.

Keywords: CHLAMYDIA TRACHOMATIS; MICROBICIDES; NEISSERIA GONORRHOEA; PREVENTION; TRICHOMONAS.

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Conflict of interest statement

Competing Interests:

None of the authors, or their immediate family, has any specified relationships with any companies that might have an interest in the submitted work. Among the remaining members of the HPTN 035 Study Team, A.P. was an employee of, and held equity interest in, Endo Pharmaceuticals Solutions, the owner of PRO 2000. T.M. was an employee of ReProtect that sponsored BufferGel for the study, and R.B., L.S.-T., and S.E. were employed by the NIH, which funded the study.

Figures

Figure 1
Figure 1. Incidence rates of non-ulcerative STIs by treatment group and location
Incidence rates are calculated as the number of new infections per 100 person-years at risk (PYAR) for incident Gonorrhoea (A), Chlamydia (B), and Trichomoniasis (C). Incidence rates are indicated by treatment group including: all groups combined (■), BufferGel (●), PRO 2000 (○), Placebo Gel (✖), and No Gel/Condoms Only (−), and 95% confidence intervals are shown as vertical lines. For each STI, incidence rates at all sites combined are presented first, followed by rates of infection at each site.
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