Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
RRHT
The Efficacy and Safety Evaluation of Standardized Treatment Included Rifampicin or Rifabutin in HIV/AIDs Patients Combined With Pulmonary Tuberculosis. A Prospective Study.
1 other identifier
interventional
230
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedStudy Start
First participant enrolled
April 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedApril 24, 2018
April 1, 2018
2.1 years
March 20, 2018
April 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (5)
Treatment completion status
12 months
The percentage of HIV viral load less than the detection limit
6 months and 12 months
AE
12 months
Time of sputum negative conversion
2~24 weeks
Chest CT scans improvement
2~24 weeks
Study Arms (2)
Rifampicin group
ACTIVE COMPARATORRifampicin 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
EXPERIMENTALRifabutin 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）
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Public Health Clinical Centerlead
- The Guangxi Zhuang Autonomous Region Longtan hospitalcollaborator
- The Fourth People's Hospital of Nanningcollaborator
- Shenzhen Third People's Hospitalcollaborator
- Yunnan Provincial Infectious Disease Hospitalcollaborator
- Zhejiang Universitycollaborator
- Chongqing Public Health Medical Centercollaborator
Study Sites (1)
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice director
Study Record Dates
First Submitted
March 20, 2018
First Posted
March 27, 2018
Study Start
April 15, 2018
Primary Completion
June 1, 2020
Study Completion
December 31, 2020
Last Updated
April 24, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share