HIV/TB Co-infection
Conditions
Interventions
Intervention Group:Short-course treatment regimen (2HRLzdZE / 2HR)
control group:Standard treatment regimen (2HRZE / 4HR)
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: Participants must be between 18 and 65 years old (inclusive), regardless of gender. 2. HIV Status: All enrolled participants must be HIV-positive. 3. Pulmonary Tuberculosis (PTB) Diagnosis: Participants must have clinically diagnosed or bacteriologically confirmed pulmonary tuberculosis (PTB), be treatment-naïve, and not have rifamycin-resistant TB. 4. Radiological Evidence: Chest X-ray or chest CT must indicate active tuberculosis (TB) lesions in the lungs. 5. Female Participants: Non-pregnant and non-lactating women who agree to use effective contraception throughout the treatment period. 6. Informed Consent: Participants must fully understand the study objectives and requirements, voluntarily sign a written informed consent form, and agree to comply with the requirements and restrictions outlined in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Severe Comorbidities: Participants with unstable or severe cardiovascular, renal, hepatic, hematologic, oncologic, endocrine/metabolic, psychiatric, or rheumatic diseases deemed unsuitable for the study by the investigator. 2. Drug Allergies: Participants with a clinically confirmed history of hypersensitivity to any investigational drug or related compounds, as determined by the investigator. 3. Pregnancy and Family Planning: Pregnant or lactating women, or those planning to conceive during the study period. 4. Compliance and Medical Risk: Participants unlikely to adhere to the study protocol or with any severe medical or psychological conditions that may interfere with the interpretation of efficacy and safety data, as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of participants continuing TB treatment, or the proportion of participants who developed active tuberculosis;mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| mortality rate;IRIS incidence;viral load suppression rate;ART initiation time;drug resistance rate;CD4+ T lymphocyte count increase;total treatment duration;adverse event incidence;the proportion of participants who developed active tuberculosis after 24 months in the randomization groups; | — |
Countries
China
Contacts
Public ContactWang Wen
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed