Short-Course Regimens for DS-PTB in AIDS Patients

N/ANot Yet RecruitingNCT07608172

Shanghai Public Health Clinical Center148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Tuberculosis in HIV-infected Individuals Drug Susceptible Pulmonary Tuberculosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

All-cause mortality at Month 12

Record the date of death and primary cause of death.

Time frame: 12 month

Secondary Outcomes

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.

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 month

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.