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NCT Number: NCT07608172

Short-Course Regimens for DS-PTB in AIDS Patients

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.

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Key information

Conditions

Tuberculosis in HIV-infected Individuals Drug Susceptible Pulmonary Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

2HPMZ/2HPM

Drug

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

2HRZE/4HR

Drug

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

Primary outcomes

  1. All-cause mortality at Month 12

    Time frame: 12 month

    Record the date of death and primary cause of death.

Secondary outcomes

  1. The rate of IRIS

    Time frame: At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48.

    Clinical symptoms and laboratory indicators

  2. Sputum culture negative conversion rate at the end of the 2nd month

    Time frame: at the end of the 2nd month

    Microbiological outcome of sputum culture

  3. The rates of AE and SAE

    Time frame: At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48.

    Adverse envents (AEs) will be graded according to CTCAE version 5.0, and the AE name, grade, causality, and outcome will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Yinzhong Shen, Professor

CONTACT

[email protected]

+86 18916113951

Sponsors and collaborators

Lead sponsor

Shanghai Public Health Clinical Center

Other Gov

Collaborators

  • Beijing Ditan Hospital
  • Beijing YouAn Hospital
  • Chengdu Public Health Clinical Center
  • Chest Hospital of Guangxi Zhuang Autonomous Region
  • Chongqing Public Health Medical Center
  • Guangzhou eighth People's Hospital ,Guangzhou Medilcal University
  • Guiyang Public Health Clinical Center
  • Meng Chao Hepatobiliary Hospital of Fujian Medical University
  • Peking Union Medical College Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • The Second Hospital of Nanjing Medical University
  • The Third People's Hospital of Yunnan Province

Registry information

Official study title

A Validation Study of Short-Course Regimens for Drug-Susceptible Pulmonary Tuberculosis in AIDS Patients

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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