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Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis (RRHT)

Primary Purpose

Tuberculosis, Pulmonary, AIDS

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rifampicin
Rifabutin
Sponsored by
Shanghai Public Health Clinical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis, Pulmonary focused on measuring Tuberculosis, AIDS, Rifampicin, Rifabutin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Public Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rifampicin group

Rifabutin group

Arm Description

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）

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）

Outcomes

Primary Outcome Measures

The rate of sputum negative conversion
The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture.
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%.

Secondary Outcome Measures

Treatment completion status
The rate of patients who complete the whole anti-tuberculous treatment.
The percentage of HIV viral load less than the detection limit
The percentage of HIV viral load less than the detection limit
AE
The number and severity of adverse event.
Time of sputum negative conversion
The time of sputum negative conversion.
Chest CT scans improvement
Chest CT showed tuberculosis lesion absorption

Full Information

First Posted
March 20, 2018
Last Updated
April 23, 2018
Sponsor
Shanghai Public Health Clinical Center
Collaborators
The Guangxi Zhuang Autonomous Region Longtan hospital, The Fourth People's Hospital of Nanning, Shenzhen Third People's Hospital, Yunnan Provincial Infectious Disease Hospital, Zhejiang University, Chongqing Public Health Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03478033
Brief Title
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Public Health Clinical Center
Collaborators
The Guangxi Zhuang Autonomous Region Longtan hospital, The Fourth People's Hospital of Nanning, Shenzhen Third People's Hospital, Yunnan Provincial Infectious Disease Hospital, Zhejiang University, Chongqing Public Health Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary, AIDS
Keywords
Tuberculosis, AIDS, Rifampicin, Rifabutin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participates are assigned to one of two groups in parallel for the duration of the study.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rifampicin group
Arm Type
Active Comparator
Arm Description
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）
Arm Title
Rifabutin group
Arm Type
Experimental
Arm Description
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）
Intervention Type
Drug
Intervention Name(s)
Rifampicin
Other Intervention Name(s)
Rifampicin/INH/EMB/PZA
Intervention Description
Rifampicin capsules, 150mg
Intervention Type
Drug
Intervention Name(s)
Rifabutin
Other Intervention Name(s)
Rifabutin/INH/EMB/PZA
Intervention Description
Rifabutin capsules, 150mg
Primary Outcome Measure Information:
Title
The rate of sputum negative conversion
Description
The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture.
Time Frame
2~24 weeks
Title
Case fatality rate
Description
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%.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Treatment completion status
Description
The rate of patients who complete the whole anti-tuberculous treatment.
Time Frame
12 months
Title
The percentage of HIV viral load less than the detection limit
Description
The percentage of HIV viral load less than the detection limit
Time Frame
6 months and 12 months
Title
AE
Description
The number and severity of adverse event.
Time Frame
12 months
Title
Time of sputum negative conversion
Description
The time of sputum negative conversion.
Time Frame
2~24 weeks
Title
Chest CT scans improvement
Description
Chest CT showed tuberculosis lesion absorption
Time Frame
2~24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongzhou Lu, PhD，MD
Phone
86-021-37990333
Ext
3222
Email
luhongzhou@fudan.edu.cn
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingzhong Shen, PhD，MD
Phone
86-021-37990333
Ext
3222
Email
027465@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis

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