Safety and Tolerability of Ultra-short Course Rifapentine and Isoniazid (1HP) for Prevention of Tuberculosis in HIV-Uninfected Individuals
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 531
- 试验地点
- 2
- 主要终点
- Number of Participants Who Complete Treatment With >90% Adherence
研究概览
简要总结
To compare treatment success (adherence and completion of treatment) and safety of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
详细描述
Tuberculosis (TB) is the leading infectious killer globally and a major cause of illness and suffering. The World Health Organization has prioritized TB preventive therapy (TPT) for people with latent TB infection (LTBI) as a key strategy for controlling the epidemic. Prevention of TB with isoniazid preventive therapy (IPT) is effective and reduces morbidity and mortality, and has been the mainstay of TB prevention for decades. But for an intervention with an excellent evidence of efficacy, global uptake has been abysmal. Completion rates for IPT when it is administered are poor (Gillespie 2008; Durovni 2010), with a large proportion of patients unable to complete treatment (McClintock 2017; Sterling 2011). While uptake is influenced by a variety of factors, a critical element has been the duration of IPT, with adherence falling sharply over time in clinical trials and practice. Shorter course regimens have a much higher completion rate and are more acceptable to patients, clinicians, and programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive tuberculin skin test or interferon-gamma release assay (IGRA) test and
- •Household contact of an infectious TB case within previous 90 days, defined as sleeping at least once in a residence with a person diagnosed with pulmonary TB, or
- •Documented conversion of Tuberculin skin test (TST)/IGRA from negative to positive within 2 years
排除标准
- •Documented HIV infection
- •Evidence of active tuberculosis on clinical exam or chest x-ray
- •Known intolerance of any study drug
- •Treatment for active or latent TB in the past for more than 14 days
- •Known close contact to someone with INH or rifampin resistant TB
- •Active liver disease or Aspartate aminotransferase(AST)/Alanine transaminase (ALT) >3 times upper limit of normal (ULN)
- •Neutropenia (ANC <1000)
- •Peripheral neuropathy >Grade 1 by DAIDS Grading Table
- •Pregnant or breastfeeding. Women of childbearing potential must agree to use non-hormonal contraception during study treatment.
- •Weight <40 kg
研究组 & 干预措施
Arm A: 1HP
Participants will receive Rifapentine 600 mg daily and isoniazid (INH) 300 mg daily for 4 weeks.
干预措施: Rifapentine 600 mg and INH 300 mg (Drug)
Arm B: 3HP
Participants will receive Rifapentine 900 mg and isoniazid 900 mg weekly for 12 weeks.
干预措施: Rifapentine 900 mg and INH 900 mg (Drug)
结局指标
主要结局
Number of Participants Who Complete Treatment With >90% Adherence
时间窗: 6 months
To compare treatment success (completion of treatment with \>90% adherence) of 1HP with 3HP in HIV-uninfected adults and adolescents at increased risk of TB.
Frequency of Targeted Adverse Events or Treatment Discontinuation for Side Effects
时间窗: 6 months
Participants with targeted adverse event grade 2 or more or discontinuing treatment for any side effect.
次要结局
未报告次要终点