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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
2HPMZ/2HPM
Drug8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin
2HRZE/4HR
Drug2 months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampin
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: 2HPMZ/2HPMExperimental treatment 1 intervention
Group B: 2HRZE/4HRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality at Month 12
Record the date of death and primary cause of death.
Time frame
12 monthSecondary outcomes
1
The rate of IRIS
Clinical symptoms and laboratory indicators
Time frame
At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48.2
Sputum culture negative conversion rate at the end of the 2nd month
Microbiological outcome of sputum culture
Time frame
at the end of the 2nd month3
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.
Time frame
At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
This trial is not recruiting at the moment. You can still explore other options: