Short-Course Regimens for DS-PTB in AIDS Patients

Summary

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.

Conditions

• Tuberculosis in HIV-infected Individuals
• Drug Susceptible Pulmonary Tuberculosis

Interventions

DRUG

2HPMZ/2HPM

8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin

DRUG

2HRZE/4HR

2 months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampin

Sponsors & Collaborators

• Beijing Ditan Hospital

  collaborator OTHER

• Guangzhou eighth People's Hospital ,Guangzhou Medilcal University

  collaborator UNKNOWN

• The Second Hospital of Nanjing Medical University

  collaborator OTHER

• Chengdu Public Health Clinical Center

  collaborator OTHER

• The Third People's Hospital of Yunnan Province

  collaborator OTHER_GOV

• Meng Chao Hepatobiliary Hospital of Fujian Medical University

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Beijing YouAn Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Guiyang Public Health Clinical Center

  collaborator UNKNOWN

• Chongqing Public Health Medical Center

  collaborator OTHER

• Chest Hospital of Guangxi Zhuang Autonomous Region

  collaborator UNKNOWN

• Shanghai Public Health Clinical Center

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-25

Primary Completion

2028-06-30

Completion

2028-12-31