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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
230
Rifampicin capsules, 150mg
Rifabutin capsules, 150mg
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
RECRUITINGThe 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
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