drugset / Trial / NCT07608172
Short-Course Regimens for DS-PTB in AIDS Patients
Not yet recruiting
148 enrolled
Shanghai Public Health Clinical Center
Beijing Ditan Hospital · collabBeijing YouAn Hospital · collabChengdu Public Health Clinical Center · collabChest Hospital of Guangxi Zhuang Autonomous Region · collabChongqing Public Health Medical Center · collabGuangzhou eighth People's Hospital ,Guangzhou Medilcal University · collabGuiyang Public Health Clinical Center · collabMeng Chao Hepatobiliary Hospital of Fujian Medical University · collabPeking Union Medical College Hospital · collabThe First Affiliated Hospital of Zhengzhou University · collabThe Second Hospital of Nanjing Medical University · collabThe Third People's Hospital of Yunnan Province · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05-25
- Primary completion
- 2028-06-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | — | — |
| Subject | Isoniazid | Small molecule | — | — |
| Subject | Moxifloxacin | Small molecule | — | — |
| Subject | Pyrazinamide | Small molecule | — | — |
| Comparator | Rifampin | Small molecule | — | — |
| Subject | Rifapentine | Small molecule | — | — |