Short-Course Regimens for DS-PTB in AIDS Patients

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.

NCT Number	NCT07608172
Lead Sponsor	Shanghai Public Health Clinical Center Collaborators: 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
Conditions	Tuberculosis in HIV-infected Individuals, Drug Susceptible Pulmonary Tuberculosis
Enrollment	148 participants
Start Date	2026-05-25
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-27