NCT07608172Not 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
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- First submitted
- 22 May 2026
- Start date
- 25 May 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Shanghai Public Health Clinical Center
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT07608172
What you commit to
- Study type: Interventional
- Planned participants: 148
- From 25 May 2026 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected resistance to any of the drugs in the regimen, including rifapentine, moxifloxacin, rifampicin, isoniazid, ethambutol, and pyrazinamide.
- Received the current tuberculosis treatment for more than 7 days.
Other illness
- Complicated with tuberculous meningitis or other severe forms of tuberculosis.
- Presence of other conditions deemed inappropriate for study participation by the investigators.
Lab values
- 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.
Other
- Body weight \< 40 kg.
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.