Tuberculosis in HIV-infected IndividualsNCT07608172
Short-Course Regimens for DS-PTB in AIDS Patients
A study testing 2HPMZ/2HPM and 2HRZE/4HR in people with Tuberculosis in HIV-infected Individuals and Drug Susceptible Pulmonary Tuberculosis, run by Shanghai Public Health Clinical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis in HIV-infected Individuals, Drug Susceptible Pulmonary Tuberculosis
- What is being tested?
- 2HPMZ/2HPM and 2HRZE/4HR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- 2HPMZ/2HPM, 2HRZE/4HR
- Keywords
- Drug susceptible pulmonary tuberculosis, HIV-infected individuals, 2HPMZ/2HPM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2HPMZ/2HPMDrug
8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin
2HRZE/4HRDrug
2 months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampin
| Study group | Role | What they receive |
|---|---|---|
| 2HPMZ/2HPM | Experimental | 8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin. Receives: Drug: 2HPMZ/2HPM |
| 2HRZE/4HR | Active comparator | 2HRZE/4HR Receives: Drug: 2HRZE/4HR |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at Month 12
Record the date of death and primary cause of death.
Measured: 12 month
Secondary outcomes (3)
The rate of IRIS
Clinical symptoms and laboratory indicators
Measured: 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
Measured: 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.
Measured: At Baseline, Week 4, Week 8, Week 12, Week 18, Week 24 and Week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start25 May 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis in HIV-infected IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- 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
- Principal investigator, Yinzhong Shen, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608172
- Sponsor's protocol ID
- DS-PTB in PLWH
- Status last verified
- Apr 2026
- First submitted
- 22 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No