Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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, 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Public Health Clinical Center
• Collaborators: Chongqing Public Health Medical Center; Shenzhen Third People's Hospital; The Fourth People's Hospital of Nanning; The Fourth People’s Hospital of Nanning; The Guangxi Zhuang Autonomous Region Longtan hospital; Yunnan Provincial Infectious Disease Hospital; Zhejiang University
• Treatments: Rifabutin; Rifampin

Criteria

Inclusion Criteria:

1. Age: 18-65 years old;

2. No limited to gender;

3. If anti-HIV-1 positive samples are detected by an initial test based on the ELISA method, they should be confirmed by western blot;

4. The patients who are diagnosed with pulmonary TB (mycobacterium tuberculosis of sputum smear or culture was positive) but had never be treated;

5. Sign informed consent form voluntarily, and guarantee to attend follow-up visits;

6. Do not have plan to remove from the current experimental site during the trial process;

7. The patients do not receive any antiretroviral treatment before;

8. The overall situation of the patient should not affect the assessment and completion of the trial.

Exclusion Criteria:

1. Patients with acute infection;

2. During the screening period，patients with combined opportunistic infections and instability (National HIV/AIDS treatment guidelines) except for tuberculosis, or combined malignancy;

3. 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;

4. Now suffering from acute or chronic pancreatitis;

5. Now suffering from peripheral neuritis;

6. Pregnant and lactating women;

7. Patients with severe mental and neurological diseases;

8. Drug users；

9. Patients with history of heavy drinking and cannot be terminated;

10. Serious gastrointestinal ulcers；

11. Atherosclerosis affects the arteries in the heart, brain or kidneys；

12. Non-Chinese nationality；

13. Now suffering from myopathy；

14. Patients with previously treated tuberculosis.