Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals

超短疗程利福喷丁和异烟肼 (1HP) 用于预防未感染 HIV 个体结核病的安全性和耐受性

基本信息

  • 批准号:
    10413161
  • 负责人:
  • 金额:
    $ 95.71万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2020
  • 资助国家:
    美国
  • 起止时间:
    2020-08-01 至 2025-05-31
  • 项目状态:
    未结题

项目摘要

Project Summary Tuberculosis (TB) is the leading infectious cause of death due to a single pathogen globally and the UN has set ambitious targets for reducing the burden of TB by 2030. TB preventive therapy (TPT) is a critical intervention for preventing TB disease and modeling studies consistently indicate that expanded TPT coverage is essential for reaching UN targets. Implementation of TPT among the populations at risk remains extremely poor, however, and new regimens that are shorter and safer than the decades-old standard of isoniazid preventive therapy are urgently needed. Over the past several decades, we have pioneered the development of short-course, rifamycin-based TPT. We demonstrated the efficacy of 3 months of weekly rifapentine and isoniazid (3HP) in people with and without HIV infection and showed that it is non-inferior to longer courses of isoniazid, with better adherence and less toxicity. This regimen is now recommended as a first-line treatment for latent TB infection by the CDC and the World Health Organization, offering the potential of substantially increased uptake of TPT as part of the END TB Strategy. More recently, supported by NIAID, we have shown that one month of daily rifapentine and isoniazid (1HP) is non-inferior to nine months of isoniazid in people with HIV infection, with higher completion rates and less toxicity. The availability of two innovative, new short- course TPT regimens offers a transformative opportunity to global TB control. The potential of a one-month regimen to catalyze uptake of TPT in high-risk populations is enormous, but data on its safety and tolerability in people without HIV infection are needed. The goal of this investigator-initiated, clinical trial application is to conduct a randomized trial comparing treatment success rates and safety of 1HP and 3HP TPT regimens in high-risk patients without HIV infection. While 3HP has been proved safe and effective in HIV-positive and –negative people, 1HP has only been shown to be safe and efficacious in HIV-positive people. Efficacy of 1HP in non-HIV populations may be inferred based on previous experience that shows comparability of TPT regimens across risk groups, but toxicity and tolerability is not known. We will 1) compare treatment success with good adherence, documented by self-report, pill count, and pharmacologic monitoring, of 1HP compared with 3HP in HIV-uninfected adults and adolescents at increased risk of TB and 2) compare the safety of 1HP vs 3HP in this population. We hypothesize that successful treatment with 1HP will be superior to 3HP, and that the safety and tolerability of 1HP will be superior to 3HP. We will also compare the cost-effectiveness of 1HP and 3HP using a societal approach, modeling the incremental cost-effectiveness of 1HP vs 3HP, 6H, and no treatment. We hypothesize that 1HP will be cost saving vs 3HP, vs modelled costs of 6H and v no TPT. The results of this trial will be extremely valuable for establishing global and US guidelines for use of 1HP in HIV-negative people.
项目总结

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Richard E. Chaisson其他文献

Efficacy of Engineering Controls in Reducing Occupational Exposure to Aerosolized Pentamidine
  • DOI:
    10.1378/chest.102.6.1764
  • 发表时间:
    1992-12-01
  • 期刊:
  • 影响因子:
  • 作者:
    Melissa A. McDiarmid;John Schaefer;Cindy Lynn Richard;Richard E. Chaisson;Byron S. Tepper
  • 通讯作者:
    Byron S. Tepper
The Impact of Prophylaxis on Outcome and Resource Utilization in <em>Pneumocystis carinii</em> Pneumonia
  • DOI:
    10.1378/chest.107.4.1018
  • 发表时间:
    1995-04-01
  • 期刊:
  • 影响因子:
  • 作者:
    Joel E. Gallant;Sharon M. McAvinue;Richard D. Moore;John G. Bartlett;David L. Stanton;Richard E. Chaisson
  • 通讯作者:
    Richard E. Chaisson
Risk-stratified treatment for drug-susceptible pulmonary tuberculosis
药物敏感型肺结核的风险分层治疗
  • DOI:
    10.1038/s41467-024-53273-7
  • 发表时间:
    2024-10-30
  • 期刊:
  • 影响因子:
    15.700
  • 作者:
    Vincent K. Chang;Marjorie Z. Imperial;Patrick P. J. Phillips;Gustavo E. Velásquez;Payam Nahid;Andrew Vernon;Ekaterina V. Kurbatova;Susan Swindells;Richard E. Chaisson;Susan E. Dorman;John L. Johnson;Marc Weiner;Amina Jindani;Thomas Harrison;Erin E. Sizemore;William Whitworth;Wendy Carr;Kia E. Bryant;Deron Burton;Kelly E. Dooley;Melissa Engle;Pheona Nsubuga;Andreas H. Diacon;Nguyen Viet Nhung;Rodney Dawson;Radojka M. Savic
  • 通讯作者:
    Radojka M. Savic
Tuberculosis Preventive Treatment in High TB-Burden Settings: A State-of-the-Art Review
  • DOI:
    10.1007/s40265-024-02131-3
  • 发表时间:
    2024-12-28
  • 期刊:
  • 影响因子:
    14.400
  • 作者:
    Violet Chihota;Makaita Gombe;Amita Gupta;Nicole Salazar-Austin;Tess Ryckman;Christopher J. Hoffmann;Sylvia LaCourse;Jyoti S. Mathad;Vidya Mave;Kelly E. Dooley;Richard E. Chaisson;Gavin Churchyard
  • 通讯作者:
    Gavin Churchyard

Richard E. Chaisson的其他文献

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{{ truncateString('Richard E. Chaisson', 18)}}的其他基金

JHU TRAC: Training and Supporting the Next Generation of TB Researchers
JHU TRAC:培训和支持下一代结核病研究人员
  • 批准号:
    10431020
  • 财政年份:
    2022
  • 资助金额:
    $ 95.71万
  • 项目类别:
JHU TRAC: Training and Supporting the Next Generation of TB Researchers
JHU TRAC:培训和支持下一代结核病研究人员
  • 批准号:
    10593142
  • 财政年份:
    2022
  • 资助金额:
    $ 95.71万
  • 项目类别:
The Johns Hopkins Center for AIDS Research (JHU CFAR)
约翰霍普金斯大学艾滋病研究中心 (JHU CFAR)
  • 批准号:
    10268586
  • 财政年份:
    2020
  • 资助金额:
    $ 95.71万
  • 项目类别:
Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals
超短疗程利福喷丁和异烟肼 (1HP) 用于预防未感染 HIV 个体结核病的安全性和耐受性
  • 批准号:
    10226377
  • 财政年份:
    2020
  • 资助金额:
    $ 95.71万
  • 项目类别:
Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals
超短疗程利福喷丁和异烟肼 (1HP) 用于预防 HIV 未感染者结核病的安全性和耐受性
  • 批准号:
    10631078
  • 财政年份:
    2020
  • 资助金额:
    $ 95.71万
  • 项目类别:
Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals
超短疗程利福喷丁和异烟肼 (1HP) 用于预防未感染 HIV 个体结核病的安全性和耐受性
  • 批准号:
    10018455
  • 财政年份:
    2020
  • 资助金额:
    $ 95.71万
  • 项目类别:
Administrative Core
行政核心
  • 批准号:
    10458358
  • 财政年份:
    2012
  • 资助金额:
    $ 95.71万
  • 项目类别:
The Johns Hopkins Center for AIDS Research (JHU CFAR)
约翰霍普金斯大学艾滋病研究中心 (JHU CFAR)
  • 批准号:
    9322787
  • 财政年份:
    2012
  • 资助金额:
    $ 95.71万
  • 项目类别:
The Johns Hopkins Center for AIDS Research (JHU CFAR)
约翰霍普金斯大学艾滋病研究中心 (JHU CFAR)
  • 批准号:
    8843334
  • 财政年份:
    2012
  • 资助金额:
    $ 95.71万
  • 项目类别:
Core-007
核心007
  • 批准号:
    10835353
  • 财政年份:
    2012
  • 资助金额:
    $ 95.71万
  • 项目类别:

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