Short-Course Regimens for DS-PTB in AIDS Patients

A Validation Study of Short-Course Regimens for Drug-Susceptible Pulmonary Tuberculosis 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis in HIV-infected Individuals; Drug Susceptible Pulmonary Tuberculosis
• Intervention / Treatment: Drug: 2HPMZ/2HPM; Drug: 2HRZE/4HR

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yinzhong Shen, Professor; Phone Number: +86 18916113951; Email: Shenyinzhong@shphc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin
Active Comparator: 2HRZE/4HR	Drug: 2HRZE/4HR; 2 months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at Month 12	Record the date of death and primary cause of death.	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of IRIS	Clinical symptoms and laboratory indicators	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	Microbiological outcome of sputum culture	at the end of the 2nd month
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.	At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Drug susceptible pulmonary tuberculosis; HIV-infected individuals; 2HPMZ/2HPM
• Other Study ID Numbers: DS-PTB in PLWH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No