Clinical trial NCT03478033: Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
Official title: The Efficacy and Safety Evaluation of Standardized Treatment Included Rifampicin or Rifabutin in HIV/AIDs Patients Combined With Pulmonary Tuberculosis. A Prospective Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis, Pulmonary
AIDS
Keywords: Tuberculosis
AIDS
Rifampicin
Rifabutin
Lead sponsor: Shanghai Public Health Clinical Center
Sponsor class: OTHER_GOV
Collaborators: name: The Guangxi Zhuang Autonomous Region Longtan hospital
name: The Fourth People's Hospital of Nanning
name: Shenzhen Third People's Hospital
name: Yunnan Provincial Infectious Disease Hospital
name: Zhejiang University
name: Chongqing Public Health Medical Center
First posted: 2018-03-27
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participates are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

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, 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.

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 (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.

Eligibility 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.

Primary outcomes:
measure: The rate of sputum negative conversion
timeFrame: 2~24 weeks
measure: Case fatality rate
timeFrame: 12 months
Secondary outcomes:
measure: Treatment completion status
timeFrame: 12 months
measure: The percentage of HIV viral load less than the detection limit
timeFrame: 6 months and 12 months
measure: AE
timeFrame: 12 months
measure: Time of sputum negative conversion
timeFrame: 2~24 weeks
measure: Chest CT scans improvement
timeFrame: 2~24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References: