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Not yet recruitingNCT07608172Updated May 27, 2026

Short-Course Regimens for DS-PTB in AIDS Patients

An interventional study of 2HPMZ/2HPM and 2HRZE/4HR in Tuberculosis in HIV-infected Individuals and Drug Susceptible Pulmonary Tuberculosis, sponsored by Shanghai Public Health Clinical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Shanghai Public Health Clinical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Drug susceptible pulmonary tuberculosis
  • HIV-infected individuals
  • 2HPMZ/2HPM
03

In context

Lead sponsor

Shanghai Public Health Clinical Center is the lead sponsor of 37 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    2HPMZ/2HPM

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

    Drug: 2HPMZ/2HPM

  • Active comparator
    2HRZE/4HR

    2HRZE/4HR

    Drug: 2HRZE/4HR

Interventions

  • Drug2HPMZ/2HPM

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

  • Drug2HRZE/4HR

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

06

What researchers measure

Primary outcomes

  1. All-cause mortality at Month 12

    Record the date of death and primary cause of death.

    Time frame: 12 month

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07608172
Lead sponsor
Shanghai Public Health Clinical Center
Collaborators
Beijing Ditan Hospital, Guangzhou eighth People's Hospital ,Guangzhou Medilcal University, The Second Hospital of Nanjing Medical University, Chengdu Public Health Clinical Center, The Third People's Hospital of Yunnan Province, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Peking Union Medical College Hospital, Beijing YouAn Hospital, The First Affiliated Hospital of Zhengzhou University, Guiyang Public Health Clinical Center, Chongqing Public Health Medical Center, Chest Hospital of Guangxi Zhuang Autonomous Region
Responsible party
Yinzhong Shen (Professor, Shanghai Public Health Clinical Center) — Principal investigator
First posted
May 27, 2026
Start date
May 25, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 27, 2026

Study contacts

Yinzhong Shen, Professor
Contact
Shenyinzhong@shphc.org.cn
+86 18916113951

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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