Browsing by Author "Husnik M"

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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.
    (2014-Aug) Guffey MB; Richardson B; Husnik M; Makanani B; Chilongozi D; Yu E; Ramjee G; Mgodi N; Gomez K; Hillier SL; Karim SA; Fred Hutchinson Cancer Research Center, Seattle, Washington, USA Department of Biostatistics, University of Washington, Seattle, Washington, USA.; University of North Carolina Project, Lilongwe, Malawi.; Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.; Department of Obstetrics and Gynaecology, University of Malawi College of Medicine, Blantyre, Malawi.; Department of Psychiatry, University of Pennsylvania, Philadelphia, Pensylvania, USA.; University of KwaZulu-Natal, CAPRISA, 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.; HIV Prevention Research Unit, South African Medical Research Council, Durban, KwaZulu-Natal, South Africa.; Departments of Medicine and Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    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.
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    Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.
    (2016-Sep) Riddler SA; Husnik M; Gorbach PM; Levy L; Parikh U; Livant E; Pather A; Makanani B; Muhlanga F; Kasaro M; Martinson F; Elharrar V; Balkus JE; h UZ-UCSF Collaborative Research Programme , University of Zimbabwe , Harare , Zimbabwe.; b MTN Statistical and Data Management Center , Fred Hutchinson Cancer Research Center , Seattle , WA , USA.; j UNC Project - Tidziwe Centre , Kamuzu Central Hospital , Lilongwe , Malawi.; g College of Medicine-John Hopkins University Research Project , Queen Elizabeth Central Hospital , Blantyre , Malawi.; k Division of AIDS , National Institutes of Health , Bethesda , MD , USA.; f HIV Prevention Research Unit , South African Medical Research Council , Durban , South Africa.; e Microbicide Trials Network , Magee-Womens Research Institute , Pittsburgh , PA , USA.; d FHI360 , Durham, NC , USA.; i Centre for Infectious Disease Research in Zambia , Lusaka , Zambia.; a Division of Infectious Diseases , University of Pittsburgh , Pittsburgh , PA , USA.; c Department of Epidemiology , University of California , Los Angeles , CA , USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort. METHODS: Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing. RESULTS: MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness. CONCLUSIONS: Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.