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| Name | Class |
|---|---|
| Beijing Ditan Hospital | OTHER |
| Guangzhou eighth People's Hospital ,Guangzhou Medilcal University | UNKNOWN |
| The Second Hospital of Nanjing Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2HPMZ/2HPM | Experimental | 8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin. |
|
| 2HRZE/4HR | Active Comparator | 2HRZE/4HR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2HPMZ/2HPM | Drug | 8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality at Month 12 | Record the date of death and primary cause of death. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of IRIS | Clinical symptoms and laboratory indicators | At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48. |
| Sputum culture negative conversion rate at the end of the 2nd month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yinzhong Shen, Professor | Contact | +86 18916113951 | Shenyinzhong@shphc.org.cn |
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| Chengdu Public Health Clinical Center |
| OTHER |
| The Third People's Hospital of Yunnan Province | OTHER_GOV |
| Meng Chao Hepatobiliary Hospital of Fujian Medical University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Beijing YouAn Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Guiyang Public Health Clinical Center | UNKNOWN |
| Chongqing Public Health Medical Center | OTHER |
| Chest Hospital of Guangxi Zhuang Autonomous Region | UNKNOWN |
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| 2HRZE/4HR | Drug | 2 months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampin |
|
Microbiological outcome of sputum culture
| at the end of the 2nd month |
| The rates of AE and SAE | Adverse envents (AEs) will be graded according to CTCAE version 5.0, and the AE name, grade, causality, and outcome will be recorded. | At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48. |