Status:
UNKNOWN
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
Lead Sponsor:
Shanghai Public Health Clinical Center
Collaborating Sponsors:
The Guangxi Zhuang Autonomous Region Longtan hospital
The Fourth People's Hospital of Nanning
Conditions:
Tuberculosis, Pulmonary
AIDS
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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,...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Age: 18-65 years old;
- No limited to gender;
- If anti-HIV-1 positive samples are detected by an initial test based on the ELISA method, they should be confirmed by western blot;
- The patients who are diagnosed with pulmonary TB (mycobacterium tuberculosis of sputum smear or culture was positive) but had never be treated;
- Sign informed consent form voluntarily, and guarantee to attend follow-up visits;
- Do not have plan to remove from the current experimental site during the trial process;
- The patients do not receive any antiretroviral treatment before;
- The overall situation of the patient should not affect the assessment and completion of the trial.
Exclusion
- Patients with acute infection;
- During the screening period，patients with combined opportunistic infections and instability (National HIV/AIDS treatment guidelines) except for tuberculosis, or combined malignancy;
- During the screening period，hemachrome \< 6 g/dl, leukocyte \< 2000 /µl, neutrophils \< 1000 /µl, platelet count \< 75000 /µl, blood amylase is greater than two times the upper limit of normal, Scr is greater than1.5 times the upper limit of normal, AST/ALT/AKP is greater than two times the upper limit of normal, TBIL is greater than two times the upper limit of normal, serum CK is greater than two times the upper limit of normal;
- Now suffering from acute or chronic pancreatitis;
- Now suffering from peripheral neuritis;
- Pregnant and lactating women;
- Patients with severe mental and neurological diseases;
- Drug users；
- Patients with history of heavy drinking and cannot be terminated;
- Serious gastrointestinal ulcers；
- Atherosclerosis affects the arteries in the heart, brain or kidneys；
- Non-Chinese nationality；
- Now suffering from myopathy；
- Patients with previously treated tuberculosis.
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT03478033
Start Date
April 15 2018
End Date
December 31 2020
Last Update
April 24 2018
Active Locations (1)
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1
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China, 201508