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| Name | Class |
|---|---|
| The Guangxi Zhuang Autonomous Region Longtan hospital | UNKNOWN |
| The Fourth People's Hospital of Nanning | OTHER |
| Shenzhen Third People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifampicin group | Active Comparator | 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) |
|
| Rifabutin group | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampicin | Drug | Rifampicin capsules, 150mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of sputum negative conversion | The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture. | 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%. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment completion status | The rate of patients who complete the whole anti-tuberculous treatment. | 12 months |
| The percentage of HIV viral load less than the detection limit | The percentage of HIV viral load less than the detection limit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongzhou Lu, PhD,MD | Contact | 86-021-37990333 | 3222 | luhongzhou@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | 201508 | China |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D000163 | Acquired Immunodeficiency Syndrome |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| D017828 | Rifabutin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Yunnan Provincial Infectious Disease Hospital |
| OTHER |
| Zhejiang University | OTHER |
| Chongqing Public Health Medical Center | OTHER |
Participates are assigned to one of two groups in parallel for the duration of the study.
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| Rifabutin | Drug | Rifabutin capsules, 150mg |
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| 6 months and 12 months |
| AE | The number and severity of adverse event. | 12 months |
| Time of sputum negative conversion | The time of sputum negative conversion. | 2~24 weeks |
| Chest CT scans improvement | Chest CT showed tuberculosis lesion absorption | 2~24 weeks |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |