A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) To Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The "One To Three" Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Treatment adherence- pill count
研究概览
简要总结
A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.
详细描述
Participants will be stratified by indication for tuberculosis (TB) preventive treatment (TPT) - HIV seropositive persons or HIV-negative household contact of person with infectious TB - and will receive either one of two TB preventive therapy regimens:
Group 1: People living with HIV infection without active TB
Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP)
Arm B: isoniazid (900mg) and rifapentine (900mg) weekly for 12 weeks (3HP)
Arm A (n=250): 250 participants age ≥13 years of age who are HIV seropositive and taking ART who do not have evidence of active TB will be recruited from local clinics. After being consented, screened, and randomized, participants in Arm A will receive the 1HP regimen once daily for 4 weeks (28 doses).
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1: People living with HIV infection without active TB
干预措施: Daily rifapentine and isoniazid for 4 weeks (Drug)
Group 1: People living with HIV infection without active TB
干预措施: Weekly rifapentine and isoniazid for 12 weeks (Drug)
Group 2: HIV-negative household contacts of adults with rifampicin-sensitive pulmonary TB
干预措施: Daily rifapentine and isoniazid for 4 weeks (Drug)
Group 2: HIV-negative household contacts of adults with rifampicin-sensitive pulmonary TB
干预措施: Weekly rifapentine and isoniazid for 12 weeks (Drug)
结局指标
主要结局
Treatment adherence- pill count
时间窗: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial
Completion of TPT with \>90% adherence documented by pill count (both groups, Arms A and B)
Treatment adherence- electronic monitoring device (EMD)
时间窗: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial
Completion of TPT with \>90% adherence documented by pill count (both groups, Arms A and B)
Early treatment discontinuation
时间窗: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2), to be reported at end of trial
discontinuation of study medications because of side effects (both groups, Arms A and B)
Treatment adherence- self-report
时间窗: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial
Completion of TPT with \>90% adherence documented by self-report (both groups, Arms A and B)
Adverse Events
时间窗: from study entry at Day 0 through Month 6 (Week 24), to be reported at end of trial
Occurrence of Grade 2 or higher targeted safety events (both groups, Arms A and B). Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever.
次要结局
- Cost-effectiveness(from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2) , to be reported at end of trial)