An interventional study of Rifampicin and Rifabutin in Tuberculosis, Pulmonary and AIDS, sponsored by Shanghai Public Health Clinical Center. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-24.
Sponsored by Shanghai Public Health Clinical Center · Not applicable, Interventional, and Treatment
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Among 28 studies in Tuberculosis, Pulmonary with a site in China — 12 open to participants now, 14 under way, 6 of them phase 3. Tuberculosis, Pulmonary · China.
Among the 28 studies in Tuberculosis, Pulmonary with a site in China, this one is the 14th largest by planned enrollment of the 21 interventional ones that give a count, is one of 2 that started in 2018, is one of 4 with no phase, and was the 8th registered.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
Browse Tuberculosis, Pulmonary studies →12 of the 28 studies in Tuberculosis, Pulmonary with a site in China are open now. Recruiting first, the newest first:
Huashan Hospital · Sites in China
Ages 3 mo–18 yrs
First Affiliated Hospital of Zhejiang University · Sites in China
Ages 18+
Shenzhen Third People's Hospital · Sites in China
Ages 18–65
ChromX Health · Sites in China
Ages 18–100 · Healthy volunteers
Beijing Chest Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 46 Tuberculosis, Pulmonary studies recruiting now, 22 (48%) set no upper age limit and 20 (43%) stop at 75 or younger; 11 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 7 · Phase 4 6
First in 2008; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 230 is above the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Median enrollment 280 across the 21 interventional studies, 800 across the 7 observational. Of the 5 that completed or were terminated, 3 (60%) have results posted.
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4 of 28 have an industry lead sponsor. The 10 most frequent:
Shanghai Public Health Clinical Center is the lead sponsor of 38 studies on the registry; 11 are open to participants now.
Shanghai Public Health Clinical Center has 2 studies filed under Tuberculosis, Pulmonary — fewer than ten, so there is no comparison to draw.
4 of the studies in Tuberculosis, Pulmonary with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06649721Phase 3Huashan HospitalInnovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort | 2027-02-28 |
| NCT07395596First Affiliated Hospital of Zhejiang UniversityRemimazolam for Bronchoscopy in High-Risk Patients | 2026-12 |
| NCT06528418ChromX HealthIdentification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath | 2026-12-30 |
| NCT07893444Huashan HospitalBRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children | 2027-11-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 28 studies in Tuberculosis, Pulmonary with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To compared the efficacy and safety of rifampicin and rifabutin which included in the standard treatment of anti-tuberculosis in HIV/AIDs patients combined with pulmonary tuberculosis, a multi-center, prospective cohort will be established. Antiviral efficacy and drug drug interaction will be investigated in order to provide optimized treatment for HIV/AIDs with tuberculosis.
Two hundreds and thirty participants will be randomly assigned to receive an anti--tuberculosis treatment include rifampicin or rifabutin for two months of intensive therapy. Isoniazid and rifampicin (or rifabutin) will be continued to use for four months of consolidation therapy. A total of followed up period will be 12 months.
The antiretroviral therapy（ART） include:
Tenofovir disoproxil fumarate 300mg/d +Lamivudine 300mg/d+ Efavirenz 600mg/d; or Zidovudine 300mg bid +Lamivudine 300mg/d +Efavirenz 600mg/d.
ART will be started after 2 weeks of anti-tuberculosis.
The follow-up visits include 2th, 4th, 6th, 8th, 12th,16th, 20th, 24th, 32th, 36th, 40th, 44th and 48th week. sputum smear, sputum culture, chest X-ray, CD4 Lymphocyte counts,HIV viral load and adverse event will be tested and recorded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rifampicin group: Intensive treatment（4 types of anti-TB medicines）for 2 months, then isoniazid and rifampicin for 4 months of consolidation therapy. isoniazid: 10-15mg/kg rifampicin: 10-20mg/kg pyrazinamide: 30-40mg/kg thambutol: 0.75(W\<50kg)；1.0 g/d（W≥50kg）
Drug: Rifampicin
Rifabutin group: Intensive treatment（4 types anti-TB medicines）for 2 months,then isoniazid and rifabutin for 4 months of consolidation therapy. isoniazid: 10-15mg/kg rifabutin: 0.45g/d(W\<50kg); 0.6g/d( W≥50kg） pyrazinamide: 30-40mg/kg thambutol: 0.75(W\<50kg)；1.0 g/d（W≥50kg）
Drug: Rifabutin
Rifampicin capsules, 150mg
Also known as: Rifampicin/INH/EMB/PZA
Rifabutin capsules, 150mg
Also known as: Rifabutin/INH/EMB/PZA
The rate of sputum negative conversion
The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture.
Time frame: 2~24 weeks
Case fatality rate
The number of deaths during follow-up caused by HIV/AIDS and TB / the number of patients with HIV/AIDs and TB enrolled in this study \* 100%.
Time frame: 12 months
Treatment completion status
The rate of patients who complete the whole anti-tuberculous treatment.
Time frame: 12 months
The percentage of HIV viral load less than the detection limit
The percentage of HIV viral load less than the detection limit
Time frame: 6 months and 12 months
AE
The number and severity of adverse event.
Time frame: 12 months
Time of sputum negative conversion
The time of sputum negative conversion.
Time frame: 2~24 weeks
Chest CT scans improvement
Chest CT showed tuberculosis lesion absorption
Time frame: 2~24 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2018 (actual). Primary completion is estimated for Jun 2020, 25 months after the start.
Of 42 non-industry interventional studies with no phase under Tuberculosis, Pulmonary, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's planned 25 months is above that.
Counting every sponsor, half of 42 studies reached it within 17 months; a quarter within 11 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rifabutin
Shanghai Public Health Clinical Center