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Not yet recruiting NCT07608172

Short-Course Regimens for DS-PTB in AIDS Patients

No phase Interventional Tuberculosis in HIV-infected Individuals Drug Susceptible Pulmonary Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 2HPMZ/2HPM, 2HRZE/4HR.
Who it may be relevant to
Registry conditions: Tuberculosis in HIV-infected Individuals, Drug Susceptible Pulmonary Tuberculosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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

Primary outcome measures

  • All-cause mortality at Month 12 [Time frame: 12 month]
Secondary outcome measures (3)
  • The rate of IRIS [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 [Time frame: at the end of the 2nd month]
  • The rates of AE and SAE [Time frame: At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07608172 · DS-PTB in PLWH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗