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Short-Course Regimens for DS-PTB in AIDS Patients

Not Yet RecruitingNA

Sponsor: Shanghai Public Health Clinical Center

Conditions: Tuberculosis in HIV-infected Individuals, Drug Susceptible Pulmonary Tuberculosis

Interventions: 2HPMZ/2HPM, 2HRZE/4HR

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.
* Agree to receive antituberculosis treatment and antiretroviral therapy during the study period.

Exclusion Criteria:

* 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.
* Severe liver dysfunction (ALT or AST \> 5 times the upper limit of normal, ULN). - - Severe renal dysfunction (eGFR \< 30 mL/min/1.73m²).
* Baseline electrocardiogram (ECG) showing QTc interval \> 500 ms.
* Pregnant or lactating women.
* Presence of other conditions deemed inappropriate for study participation by the investigators.