NCT07608172|Not Yet Recruiting
Short-Course Regimens for DS-PTB in AIDS Patients
A Validation Study of Short-Course Regimens for Drug-Susceptible Pulmonary Tuberculosis in AIDS Patients
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A Validation Study of Short-Course Regimens for Drug-Susceptible Pulmonary Tuberculosis in AIDS Patients
Sponsor study identifier
interventional
148
0 countries
N/A
Study Start
May 25, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 22, 2026
Actual (reported)May 25, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 27, 2026
Actual (reported)June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
All-cause mortality at Month 12
Record the date of death and primary cause of death.
12 month
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.
8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin.
2HRZE/4HR
8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin
2 months of isoniazid, rifampin, pyrazinamide, and ethambutol followed by 4 months of isoniazid and rifampin
First Submitted
May 22, 2026
First Posted
May 27, 2026
Study Start
May 25, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2028
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 27, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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