Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis

AIDS Clinical Trial

— RRHT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03478033
• Other study ID #: 2017ZX10202101-002
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2018
• Last updated: April 23, 2018
• Start date: April 15, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2018
• Source: Shanghai Public Health Clinical Center
• Contact: Hongzhou Lu, PhD,MD
• Phone: 86-021-37990333
• Email: luhongzhou[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 31, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• AIDS
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Rifampicin
Rifampicin capsules, 150mg
• Rifabutin
Rifabutin capsules, 150mg

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Public Health Clinical Center	Chongqing Public Health Medical Center, Shenzhen Third People's Hospital, The Fourth People’s Hospital of Nanning, The Guangxi Zhuang Autonomous Region Longtan hospital, Yunnan Provincial Infectious Disease Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of sputum negative conversion	The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture.	2~24 weeks
Primary	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%.	12 months
Secondary	Treatment completion status	The rate of patients who complete the whole anti-tuberculous treatment.	12 months
Secondary	The percentage of HIV viral load less than the detection limit	The percentage of HIV viral load less than the detection limit	6 months and 12 months
Secondary	AE	The number and severity of adverse event.	12 months
Secondary	Time of sputum negative conversion	The time of sputum negative conversion.	2~24 weeks
Secondary	Chest CT scans improvement	Chest CT showed tuberculosis lesion absorption	2~24 weeks