NCT07608172

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started May 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Dec 2028

First Submitted

Initial submission to the registry

May 22, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

May 22, 2026

Last Update Submit

May 24, 2026

Conditions

Tuberculosis in HIV-infected IndividualsDrug Susceptible Pulmonary Tuberculosis

Keywords

Drug susceptible pulmonary tuberculosisHIV-infected individuals2HPMZ/2HPM

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality at Month 12

    Record the date of death and primary cause of death.

    12 month

Secondary Outcomes (3)

  • The rate of IRIS

    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

    at the end of the 2nd month

  • The rates of AE and SAE

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

Study Arms (2)

2HPMZ/2HPM

EXPERIMENTAL

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

Drug: 2HPMZ/2HPM

2HRZE/4HR

ACTIVE COMPARATOR

2HRZE/4HR

Drug: 2HRZE/4HR

Interventions

2HPMZ/2HPMDRUG

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

2HPMZ/2HPM
2HRZE/4HRDRUG

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

2HRZE/4HR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Yinzhong Shen, Professor

CONTACT

+86 18916113951Shenyinzhong@shphc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 27, 2026

Study Start

May 25, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share