Tuberculosis, PulmonaryRRHTNCT03478033
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
A study testing Rifampicin and Rifabutin in people with Tuberculosis, Pulmonary and AIDS, run by Shanghai Public Health Clinical Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tuberculosis, Pulmonary, AIDS
- What is being tested?
- Rifampicin and Rifabutin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508
Yingzhong Shen, PhD，MD, 86-021-37990333 ext. 3222, 027465@163.com
About this study
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.
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.
Read the 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
- Being tested
- Rifampicin, Rifabutin
- Keywords
- Tuberculosis, AIDS, Rifampicin, Rifabutin
- Medical subject headings
- Tuberculosis, Pulmonary, Acquired Immunodeficiency Syndrome, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampicinDrug
Also called Rifampicin/INH/EMB/PZA
Rifampicin capsules, 150mg
RifabutinDrug
Also called Rifabutin/INH/EMB/PZA
Rifabutin capsules, 150mg
| Study group | Role | What they receive |
|---|---|---|
| Rifampicin group | Active comparator | 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） Receives: Drug: Rifampicin |
| Rifabutin group | Experimental | 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） Receives: Drug: Rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of sputum negative conversion
The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture.
Measured: 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%.
Measured: 12 months
Secondary outcomes (5)
Treatment completion status
The rate of patients who complete the whole anti-tuberculous treatment.
Measured: 12 months
The percentage of HIV viral load less than the detection limit
The percentage of HIV viral load less than the detection limit
Measured: 6 months and 12 months
AE
The number and severity of adverse event.
Measured: 12 months
Time of sputum negative conversion
The time of sputum negative conversion.
Measured: 2~24 weeks
Chest CT scans improvement
Chest CT showed tuberculosis lesion absorption
Measured: 2~24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start15 Apr 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participates are assigned to one of two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Hongzhou Lu, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478033
- Sponsor's protocol ID
- 2017ZX10202101-002
- Acronym
- RRHT
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03478033
- Acronym / sponsor ID
- RRHT / 2017ZX10202101-002
- Conditions
- Tuberculosis, Pulmonary, AIDS
- Keywords
- Tuberculosis, AIDS, Rifampicin, Rifabutin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- 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
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participates are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Rifampicin group | Active comparator | Drug: RifampicinRifampicin 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 | Experimental | Drug: RifabutinRifabutin 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） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifampicinAlso: Rifampicin/INH/EMB/PZARifampicin capsules, 150mg | Drug | Rifampicin group |
| RifabutinAlso: Rifabutin/INH/EMB/PZARifabutin capsules, 150mg | Drug | Rifabutin group |
Primary outcome
The rate of sputum negative conversion
Time frame: 2~24 weeks
The rate of the patients whose mycobacterium tuberculosis cannot be detected in sputum smear or bacteria culture.
Case fatality rate
Time frame: 12 months
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%.
5 secondary outcomes
Treatment completion status
Time frame: 12 months
The percentage of HIV viral load less than the detection limit
Time frame: 6 months and 12 months
AE
Time frame: 12 months
Time of sputum negative conversion
Time frame: 2~24 weeks
Chest CT scans improvement
Time frame: 2~24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifampicin and Rifabutin in people with Tuberculosis, Pulmonary and AIDS, run by Shanghai Public Health Clinical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongzhou Lu, PhD，MD (86-021-37990333 ext. 3222, luhongzhou@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of sputum negative conversion (time frame: 2~24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.