Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis

NCT ID: NCT03478033

Last Updated: 2018-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-15
• Study Completion Date: 2020-12-31

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.

Conditions

Tuberculosis, Pulmonary; AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rifampicin group

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）

Group Type: ACTIVE_COMPARATOR

Rifampicin

Intervention Type: DRUG

Rifampicin capsules, 150mg

Rifabutin group

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）

Group Type: EXPERIMENTAL

Rifabutin

Intervention Type: DRUG

Rifabutin capsules, 150mg

Interventions

Rifampicin

Rifampicin capsules, 150mg

Intervention Type: DRUG

Rifabutin

Rifabutin capsules, 150mg

Intervention Type: DRUG

Other Intervention Names

Rifampicin/INH/EMB/PZA; Rifabutin/INH/EMB/PZA

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Guangxi Zhuang Autonomous Region Longtan hospital

UNKNOWN

Sponsor Role: collaborator

The Fourth People's Hospital of Nanning

OTHER

Sponsor Role: collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role: collaborator

Yunnan Provincial Infectious Disease Hospital

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

Chongqing Public Health Medical Center

OTHER

Sponsor Role: collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hongzhou Lu

vice director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongzhou Lu, PhD，MD

Role: CONTACT

luhongzhou@fudan.edu.cn

86-021-37990333 ext. 3222

Facility Contacts

Yingzhong Shen, PhD，MD

Role: primary

027465@163.com

86-021-37990333 ext. 3222

Other Identifiers

2017ZX10202101-002

Identifier Type: -

Identifier Source: org_study_id