Short-Course Regimens for DS-PTB in AIDS Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Public Health Clinical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 2HPMZ/2HPM
- 2HRZE/4HR
Treatment groups
148 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Shanghai Public Health Clinical Center
Lead sponsor
Beijing Ditan Hospital
Collaborator
Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
Collaborator
The Second Hospital of Nanjing Medical University
Collaborator
Chengdu Public Health Clinical Center
Collaborator
The Third People's Hospital of Yunnan Province
Collaborator
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Collaborator
Peking Union Medical College Hospital
Collaborator
Beijing YouAn Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Guiyang Public Health Clinical Center
Collaborator
Chongqing Public Health Medical Center
Collaborator
Chest Hospital of Guangxi Zhuang Autonomous Region
Collaborator
Source ClinicalTrials.gov