Drug Susceptible Pulmonary Tuberculosis, Tuberculosis in HIV-infected Individuals
Conditions
Keywords
Drug susceptible pulmonary tuberculosis, HIV-infected individuals, 2HPMZ/2HPM
Brief summary
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.
Interventions
DRUG2HPMZ/2HPM
8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin
DRUG2HRZE/4HR
2 months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampin
Sponsors
Shanghai Public Health Clinical Center
Beijing Ditan Hospital
Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
The Second Hospital of Nanjing Medical University
Chengdu Public Health Clinical Center
The Third People's Hospital of Yunnan Province
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Peking Union Medical College Hospital
Beijing YouAn Hospital
The First Affiliated Hospital of Zhengzhou University
Guiyang Public Health Clinical Center
Chongqing Public Health Medical Center
Chest Hospital of Guangxi Zhuang Autonomous Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality at Month 12 | 12 month | Record the date of death and primary cause of death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of IRIS | At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48. | Clinical symptoms and laboratory indicators |
| Sputum culture negative conversion rate at the end of the 2nd month | at the end of the 2nd month | Microbiological outcome of sputum culture |
| The rates of AE and SAE | At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48. | Adverse envents (AEs) will be graded according to CTCAE version 5.0, and the AE name, grade, causality, and outcome will be recorded. |
Contacts
CONTACTYinzhong Shen, Professor
Outcome results
None listed