Drug-Susceptible Pulmonary Tuberculosis in AIDS patients
Conditions
Interventions
Experimental Group:8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin
Control Group:2HRZE/4HR
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, able to understand and sign the informed consent form. 2.Confirmed HIV infection. 3. Baseline CD4+ T-lymphocyte count < 100 cells/µL. 4.Confirmed active pulmonary tuberculosis. 5.Agree to receive antituberculosis treatment and antiretroviral therapy during the study period.
Exclusion criteria
Exclusion criteria: 1. Known or suspected resistance to any of the drugs in the regimen, including rifapentine, moxifloxacin, rifampicin, isoniazid, ethambutol, and pyrazinamide. 2. Body weight 5 times the upper limit of normal, ULN). 6. Severe renal dysfunction (eGFR 500 ms. 8. Pregnant or lactating women. 9. Presence of other conditions deemed inappropriate for study participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality? at Month 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of IRIS;AE and SAE;Sputum culture negative conversion rate at the end of the 2nd month; | — |
Countries
China
Contacts
Public Contactshenyinzhong
Shanghai Public Health Clinical Center
Outcome results
None listed