A Validation Study of Short-Course Regimens for Drug-Susceptible Pulmonary Tuberculosis in AIDS Patients

Shanghai Public Health Clinical Center0 个研究点目标入组 148 人开始时间: 2026年5月25日最近更新: 2026年5月27日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Shanghai Public Health Clinical Center
入组人数: 148

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

This study adopts a multicenter, open-label, randomized controlled design, conducted across key designated AIDS diagnosis and treatment hospitals nationwide. It aims to compare the efficacy and safety of the 2HPMZ/2HPM regimen versus the 2HRZE/4HR regimen in treating HIV-associated drug-susceptible pulmonary tuberculosis (DS-TB) among patients with a CD4+ T-cell count < 100 cells/μL. A total of 148 participants will be enrolled and randomized 1:1 into two groups: 74 cases in the 2HPMZ/2HPM group and 74 cases in the 2HRZE/4HR group.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥ 18 years, able to understand and sign the informed consent form.
•Confirmed HIV infection.
•Baseline CD4+ T-lymphocyte count < 100 cells/μL.
•Confirmed active pulmonary tuberculosis.
•Agree to receive antituberculosis treatment and antiretroviral therapy during the study period.

排除标准

•Known or suspected resistance to any of the drugs in the regimen, including rifapentine, moxifloxacin, rifampicin, isoniazid, ethambutol, and pyrazinamide.
•Body weight < 40 kg.
•Received the current tuberculosis treatment for more than 7 days.
•Complicated with tuberculous meningitis or other severe forms of tuberculosis.
•Severe liver dysfunction (ALT or AST > 5 times the upper limit of normal, ULN). - - Severe renal dysfunction (eGFR < 30 mL/min/1.73m²).
•Baseline electrocardiogram (ECG) showing QTc interval > 500 ms.
•Pregnant or lactating women.
•Presence of other conditions deemed inappropriate for study participation by the investigators.

研究者

发起方

Shanghai Public Health Clinical Center

申办方类型

Other Gov

责任方

Principal Investigator

主要研究者

Yinzhong Shen

Professor

Shanghai Public Health Clinical Center

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