HIVNCT02712671
Testing for Tuberculosis in the United Kingdom HIV Infected Population
An observational study of HIV and Latent Tuberculosis, run by University College, London at 1 site in United Kingdom.
Trial summary
Human Immunodeficiency Virus (HIV) is the strongest individual risk factor for the reactivation of tuberculosis (TB) after previous exposure to Mycobacterium tuberculosis (MTb). This risk is reduced but not completely eliminated when HIV is treated with antiretroviral therapy (ART). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Latent Tuberculosis
- What is being tested?
- Chest radiograph, Blood interferon gamma release assay and Tuberculin skin testing (TST)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Sep 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending an ambulatory clinic for Human Immunodeficiency Virus (HIV) care in London.
Who may be able to join
- New diagnosis of HIV or established in care in HIV clinic by stratified sampling
- Able to give informed consent
Who cannot join
- Diagnosis of active TB or undergoing treatment for active or latent TB
- Inability to produce sputum by coughing (e.g. recent rib fracture, chest pain, pneumothorax)
- Pregnancy
- Use of steroids (equivalent to 15mg prednisolone for ≥4 weeks) or any other immunosuppressive drugs (e.g. azathioprine) - relative
- Active solid organ or haematological malignancy (excluding Kaposi's sarcoma)
- Previous hypersensitivity to purified protein derivative (PPD)
- Extensive eczema
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ian Charleson Centre, Royal Free Hospital
London, NW3 2QG
About this study
Official title: Study of Systematic Tuberculosis Testing for Active, Sub-clinical and Latent Tuberculosis Infection in a United Kingdom Human Immunodeficiency Virus (HIV) Infected Cohort
Human Immunodeficiency Virus (HIV) is the strongest individual risk factor for the reactivation of tuberculosis (TB) after previous exposure to Mycobacterium tuberculosis (MTb). This risk is reduced but not completely eliminated when HIV is treated with antiretroviral therapy (ART). Both the British HIV Association (BHIVA) and National Institute of Health and Care Excellence (NICE) suggest testing for latent TB infection in HIV infected individuals, but use different criteria. The cost -effectiveness of either approach has not been assessed, nor is testing widespread. A certain proportion of HIV infected subjects in Africa have MTb detectable in their sputum despite not having symptoms (such as cough or weight loss), nor changes on a chest x ray. It is unclear if this happens in lower TB prevalence areas such as the United Kingdom (UK). We intend to test a cohort of HIV infected subjects for evidence of latent TB using a tuberculin skin test (TST) and Interferon Gamma Release Assay (IGRA), ask about symptoms (using a standardised questionnaire) and to induce sputum using a saline nebuliser, to detect MTb using microscopy and culture, and newer nucleic acid amplification (genetic) techniques. Some patients, despite being exposed to TB in the past, will not mount a response using an IGRA or TST, which maybe due to an abnormal immune response. This lack of response seems more common in HIV. By investigating the number of patients with positive TST, IGRA, chest X ray and evidence of MTb in their sputum, in the context of place of birth, previous exposure to TB, CD4 count and other medications, we can assess the cost- effectiveness of systematic TB screening and the use anti-TB antibiotics to prevent reactivation of TB. In time, we will be able to answer important questions about the time taken to reactivate TB in individuals with HIV who do or don't take preventative anti-TB medications in the UK.
Read the detailed description
The investigators would like to assess a cohort of human immunodeficiency virus (HIV) infected individuals at the Ian Charleson Centre, Royal Free Hospital to assess the rates of latent tuberculosis infection (LTBI) using both tuberculin skin test (TST) and interferon gamma release assay (IGRA), systematically investigating for active tuberculosis (TB) with a symptom questionnaire and chest X ray, and test for Mycobacterium tuberculosis (MTb) in their sputum, both coughed up spontaneously where possible and by inducing sputum using a saline nebuliser and testing this using microscopy and culture (the established method for detecting MTb), nucleic acid amplification testing (using Xpert.TB, a new genetic test for TB that decreases the time required for detection) and a novel 16S ribosomal ribonucleic acid (RNA) test, used to look for TB burden.
A cohort of people with HIV infection will be invited to take part in the study. Subjects will have varying place of origin, TB exposure risk, blood cluster of differentiation 4 (CD4) cell count, HIV viral load, exposure to antiretroviral drugs used to treat HIV. All patients with a new diagnosis of HIV will be invited, as will a group of subjects already undergoing HIV care (selected by stratified sampling) in order to recruit 180 subjects originating from sub-Saharan African countries and 120 from lower TB incidence countries (such as the United Kingdom, UK and Western Europe). The study is powered to detect a difference between all forms of TB infection in subjects from sub-Saharan Africa to those from the UK (or other low TB prevalence countries) with 80% power, allowing a 5% type I error.
The participants will be recruited and a questionnaire, X ray, sputum induction, TST and IGRA can be taken in one visit. They will need to return 48--72 hours later to have the TST read on their arm. Those with evidence of LTBI (with positive TST or IGRA) will be invited to TB/HIV clinic and quality of life scores recorded as part of the study.
Research Questions:
- To determine the feasibility, yield and cost--effectiveness of testing for M. tuberculosis infection in UK HIV infected individuals.
- To determine the prevalence of subclinical and active TB in a UK HIV infected clinic
- To determine the sensitivity and specificity of systematic screening questionnaires for detecting cases of active TB outside of high TB prevalence settings
- To determine concordance between TST and blood IGRA (T-Spot.TB) in latent TB infection
- To identify risk factors for latent TB infection in the clinic population
- To determine the underlying frequency of airways disease (using spirometry) and of respiratory symptoms
- To determine the sensitivity and specificity of 'Xpert MTB/RIF' polymerase chain reaction (PCR) testing of sputum and induced sputum compared to mycobacterial microscopy and culture
- To compare the Molecular Bacterial Load (MBL) assay, based on 16S rRNA, and other available molecular assays, with Xpert MTB/RIF for detection of Mtb
- To determine quality of life scores (EQ-5D) for those with HIV infection, with and without latent TB infection and/or undergoing treatment On those with evidence of LTBI:
- To determine uptake of latent TB therapy (6 months isoniazid treatment)
- To determine cost of latent TB treatment (including screening costs, clinic time)
- To determine quality of life and rate and severity of adverse events on latent TB treatment
- To determine rate and time until active TB in those with LTBI on or off antiretroviral therapy (ART) and/or isoniazid prophylaxis In all patients (over 20 year follow up):
- To determine the rate of incident active TB
- To determine the time until progression to active TB with in patients with abnormal radiographic changes consistent with old tuberculosis exposure or disease
Data will be generated by the Research team and University College London (UCL) Statistics team.
- Conditions
- HIV, Latent Tuberculosis
- Being tested
- Chest radiograph, Blood interferon gamma release assay, Tuberculin skin testing (TST), Sputum induction for mycobacterial microscopy and culture, Mycobacterium tuberculosis polymerase chain reaction testing
- Keywords
- Cost-Benefit Analysis, Quality of Life
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest radiographRadiation
Also called Chest X ray
A chest radiograph involves the participant standing in front of a film and a low dose of radiation passes through the chest. This will be used to look for evidence of tuberculosis infection.
Blood interferon gamma release assayProcedure or surgery
Also called Blood IGRA, TSpot.TB
Test of T-lymphocytes' response to exposure with tuberculosis antigens. This test is used for the diagnosis of latent tuberculosis infection and involves a blood sample in lithium heparin tube. It will be performed in an off site laboratory (Oxford Immunotec, Abingdon, Oxfordshire, United Kingdom).
Tuberculin skin testing (TST)Procedure or surgery
Also called TST, Mantoux test
An intradermal test for latent tuberculosis infection that involves a small injection of purified protein derivative (PPD) from inactivated Mycobacterium tuberculosis. The reaction is interpreted at 48-72 hours by measuring the induration produced.
Sputum induction for mycobacterial microscopy and cultureProcedure or surgery
Participants will breathe in a nebuliser salt solution (3.5% normal saline) for 15 minutes and asked to cough up a sputum sample. This is undertaken in a negative pressure tent. The sample will be tested for mycobacteria under the microscope and then cultured for 42 days in liquid culture bottles the microbiology laboratory.
Mycobacterium tuberculosis polymerase chain reaction testingOther
Also called TB PCR, GeneXpert MTB/RIF
Sputum from sputum induction will be tested using the GeneXpert system using polymerase chain reaction to identify genes present in Mycobacterium tuberculosis. This test is performed in a microbiology laboratory and tests for the presence of Mycobacterium tuberculosis in sputum, plus genes associated with drug resistance.
SpirometryProcedure or surgery
Also called Lung function
Participants will be asked to blow into a spirometer to measure how much air they can expel in one second and in a whole breath. This will be repeated six times (three times before inhaling 3.5% saline solution and three times five minutes after breathing 3.5% saline solution). The results will be used to identify those whose airways are sensitive to the solution and to look for the presence of airways disease (asthma or chronic obstructive pulmonary disease).
| Study group | Role | What they receive |
|---|---|---|
| Enrolled subjects | Subjects attending the Ian Charleson Centre and agreeing to be tested for latent, subclinical and active tuberculosis using Chest radiograph, Blood interferon gamma release assay, Tuberculin skin testing, Sputum induction for mycobacterial microscopy and culture with spirometry, and Mycobacterium tuberculosis polymerase chain reaction testing. Receives: Radiation: Chest radiograph; Procedure: Blood interferon gamma release assay; Procedure: Tuberculin skin testing (TST); Procedure: Sputum induction for mycobacterial microscopy and culture; Other: Mycobacterium tuberculosis polymerase chain reaction testing; Procedure: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of active tuberculosis disease
Number of cases of active TB disease amongst the enrolled subjects, defined by the number of participants with X ray changes consistent with active tuberculosis and/or sputum culture positive for Mycobacterium tuberculosis with symptoms consistent with tuberculosis disease.
Measured: 1 year
Number of cases of subclinical tuberculosis
Number of cases of subclinical tuberculosis amongst the enrolled subjects, defined by the number of participants with sputum culture positive for Mycobacterium tuberculosis, with or without X ray changes consistent with active tuberculosis and without symptoms consistent with tuberculosis disease.
Measured: 1 year
Number of cases latent tuberculosis infection
Number of cases of latent tuberculosis infection amongst the enrolled subjects, defined by the number of participants with with positive tuberculin skin test (TST) and/or interferon gamma release assay (IGRA) (for latent TB infection), but without a history of previous, treated tuberculosis disease and without symptoms, X ray changes consistent with active tuberculosis disease or sputum culture positive for Mycobacterium tuberculosis.
Measured: 1 year
Secondary outcomes (7)
Number with subsequent active TB disease
Number of participants that develop new TB disease after the testing period has taken place
Measured: 20 years
Time to subsequent active TB disease
Time (months) from when testing took place to subsequent active TB disease in those that develop it.
Measured: 20 years
Number of participants with a diagnosis of airways disease in an HIV infected cohort
Number of participants with symptoms of airways disease (asthma or chronic obstructive pulmonary disease) defined as Forced Expiratory Volume in one second divided by the forced vital capacity <0.7 on spirometry and respiratory symptoms.
Measured: 2 years
Quality of life scores for those with HIV infection with or without TB infection.
Quality of life scores using the EuroQol 5 Dimensions (EQ5D) questionnaire for those with HIV infection, with and without latent TB infection and/or undergoing treatment.
Measured: 2 years
Uptake of latent TB preventive treatment in an HIV clinic cohort
Number of participants that agree to take latent tuberculosis preventive therapy in those with a new diagnosis of latent TB infection divided by the number of patients with a new diagnosis of latent tuberculosis infection.
Measured: 2 years
Cost of latent TB preventive treatment in an HIV clinic cohort
The sum of the costs (£ sterling) associated with preventive treatment for latent tuberculosis infection divided by the number of participants with a diagnosis of latent tuberculosis infection, measured from a United Kingdom National Health Service perspective.
Measured: 2 years
Number of adverse events for each participant taking latent TB preventive treatment
Number and type of adverse events whilst taking latent tuberculosis preventive therapy, measured using standardised adverse effects questionnaires.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJun 2013
- Primary completionFeb 2016
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Lipman, MD, Principal investigator, Clinical Senior Lecturer and Consultant Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712671
- Sponsor's protocol ID
- UCL 12/0212
- Status last verified
- May 2017
- First submitted
- 29 Feb 2016
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Systematic Tuberculosis Testing for Active, Sub-clinical and Latent Tuberculosis Infection in a United Kingdom Human Immunodeficiency Virus (HIV) Infected Cohort
- ClinicalTrials.gov ID
- NCT02712671
- Acronym / sponsor ID
- UCL 12/0212
- Conditions
- HIV, Latent Tuberculosis
- Keywords
- Cost-Benefit Analysis, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 Mar 2016 (estimated)
- 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.
Human Immunodeficiency Virus (HIV) is the strongest individual risk factor for the reactivation of tuberculosis (TB) after previous exposure to Mycobacterium tuberculosis (MTb). This risk is reduced but not completely eliminated when HIV is treated with antiretroviral therapy (ART). Both the British HIV Association (BHIVA) and National Institute of Health and Care Excellence (NICE) suggest testing for latent TB infection in HIV infected individuals, but use different criteria. The cost -effectiveness of either approach has not been assessed, nor is testing widespread. A certain proportion of HIV infected subjects in Africa have MTb detectable in their sputum despite not having symptoms (such as cough or weight loss), nor changes on a chest x ray. It is unclear if this happens in lower TB prevalence areas such as the United Kingdom (UK). We intend to test a cohort of HIV infected subjects for evidence of latent TB using a tuberculin skin test (TST) and Interferon Gamma Release Assay (IGRA), ask about symptoms (using a standardised questionnaire) and to induce sputum using a saline nebuliser, to detect MTb using microscopy and culture, and newer nucleic acid amplification (genetic) techniques. Some patients, despite being exposed to TB in the past, will not mount a response using an IGRA or TST, which maybe due to an abnormal immune response. This lack of response seems more common in HIV. By investigating the number of patients with positive TST, IGRA, chest X ray and evidence of MTb in their sputum, in the context of place of birth, previous exposure to TB, CD4 count and other medications, we can assess the cost- effectiveness of systematic TB screening and the use anti-TB antibiotics to prevent reactivation of TB. In time, we will be able to answer important questions about the time taken to reactivate TB in individuals with HIV who do or don't take preventative anti-TB medications in the UK.
Detailed description
The investigators would like to assess a cohort of human immunodeficiency virus (HIV) infected individuals at the Ian Charleson Centre, Royal Free Hospital to assess the rates of latent tuberculosis infection (LTBI) using both tuberculin skin test (TST) and interferon gamma release assay (IGRA), systematically investigating for active tuberculosis (TB) with a symptom questionnaire and chest X ray, and test for Mycobacterium tuberculosis (MTb) in their sputum, both coughed up spontaneously where possible and by inducing sputum using a saline nebuliser and testing this using microscopy and culture (the established method for detecting MTb), nucleic acid amplification testing (using Xpert.TB, a new genetic test for TB that decreases the time required for detection) and a novel 16S ribosomal ribonucleic acid (RNA) test, used to look for TB burden.
A cohort of people with HIV infection will be invited to take part in the study. Subjects will have varying place of origin, TB exposure risk, blood cluster of differentiation 4 (CD4) cell count, HIV viral load, exposure to antiretroviral drugs used to treat HIV. All patients with a new diagnosis of HIV will be invited, as will a group of subjects already undergoing HIV care (selected by stratified sampling) in order to recruit 180 subjects originating from sub-Saharan African countries and 120 from lower TB incidence countries (such as the United Kingdom, UK and Western Europe). The study is powered to detect a difference between all forms of TB infection in subjects from sub-Saharan Africa to those from the UK (or other low TB prevalence countries) with 80% power, allowing a 5% type I error.
The participants will be recruited and a questionnaire, X ray, sputum induction, TST and IGRA can be taken in one visit. They will need to return 48--72 hours later to have the TST read on their arm. Those with evidence of LTBI (with positive TST or IGRA) will be invited to TB/HIV clinic and quality of life scores recorded as part of the study.
Research Questions:
- To determine the feasibility, yield and cost--effectiveness of testing for M. tuberculosis infection in UK HIV infected individuals.
- To determine the prevalence of subclinical and active TB in a UK HIV infected clinic
- To determine the sensitivity and specificity of systematic screening questionnaires for detecting cases of active TB outside of high TB prevalence settings
- To determine concordance between TST and blood IGRA (T-Spot.TB) in latent TB infection
- To identify risk factors for latent TB infection in the clinic population
- To determine the underlying frequency of airways disease (using spirometry) and of respiratory symptoms
- To determine the sensitivity and specificity of 'Xpert MTB/RIF' polymerase chain reaction (PCR) testing of sputum and induced sputum compared to mycobacterial microscopy and culture
- To compare the Molecular Bacterial Load (MBL) assay, based on 16S rRNA, and other available molecular assays, with Xpert MTB/RIF for detection of Mtb
- To determine quality of life scores (EQ-5D) for those with HIV infection, with and without latent TB infection and/or undergoing treatment On those with evidence of LTBI:
- To determine uptake of latent TB therapy (6 months isoniazid treatment)
- To determine cost of latent TB treatment (including screening costs, clinic time)
- To determine quality of life and rate and severity of adverse events on latent TB treatment
- To determine rate and time until active TB in those with LTBI on or off antiretroviral therapy (ART) and/or isoniazid prophylaxis In all patients (over 20 year follow up):
- To determine the rate of incident active TB
- To determine the time until progression to active TB with in patients with abnormal radiographic changes consistent with old tuberculosis exposure or disease
Data will be generated by the Research team and University College London (UCL) Statistics team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled subjects | – | Radiation: Chest radiograph, Procedure: Blood interferon gamma release assay, Procedure: Tuberculin skin testing (TST), Procedure: Sputum induction for mycobacterial microscopy and culture, Other: Mycobacterium tuberculosis polymerase chain reaction testing, Procedure: SpirometrySubjects attending the Ian Charleson Centre and agreeing to be tested for latent, subclinical and active tuberculosis using Chest radiograph, Blood interferon gamma release assay, Tuberculin skin testing, Sputum induction for mycobacterial microscopy and culture with spirometry, and Mycobacterium tuberculosis polymerase chain reaction testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending an ambulatory clinic for Human Immunodeficiency Virus (HIV) care in London.
Key inclusion criteria (2 listed)
- New diagnosis of HIV or established in care in HIV clinic by stratified sampling
- Able to give informed consent
Key exclusion criteria (7 listed)
- Diagnosis of active TB or undergoing treatment for active or latent TB
- Inability to produce sputum by coughing (e.g. recent rib fracture, chest pain, pneumothorax)
- Pregnancy
- Use of steroids (equivalent to 15mg prednisolone for ≥4 weeks) or any other immunosuppressive drugs (e.g. azathioprine) - relative
- Active solid organ or haematological malignancy (excluding Kaposi's sarcoma)
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 |
|---|---|---|
| Chest radiographAlso: Chest X rayA chest radiograph involves the participant standing in front of a film and a low dose of radiation passes through the chest. This will be used to look for evidence of tuberculosis infection. | Radiation | Enrolled subjects |
| Blood interferon gamma release assayAlso: Blood IGRA, TSpot.TBTest of T-lymphocytes' response to exposure with tuberculosis antigens. This test is used for the diagnosis of latent tuberculosis infection and involves a blood sample in lithium heparin tube. It will be performed in an off site laboratory (Oxford Immunotec, Abingdon, Oxfordshire, United Kingdom). | Procedure or surgery | Enrolled subjects |
| Tuberculin skin testing (TST)Also: TST, Mantoux testAn intradermal test for latent tuberculosis infection that involves a small injection of purified protein derivative (PPD) from inactivated Mycobacterium tuberculosis. The reaction is interpreted at 48-72 hours by measuring the induration produced. | Procedure or surgery | Enrolled subjects |
| Sputum induction for mycobacterial microscopy and cultureParticipants will breathe in a nebuliser salt solution (3.5% normal saline) for 15 minutes and asked to cough up a sputum sample. This is undertaken in a negative pressure tent. The sample will be tested for mycobacteria under the microscope and then cultured for 42 days in liquid culture bottles the microbiology laboratory. | Procedure or surgery | Enrolled subjects |
| Mycobacterium tuberculosis polymerase chain reaction testingAlso: TB PCR, GeneXpert MTB/RIFSputum from sputum induction will be tested using the GeneXpert system using polymerase chain reaction to identify genes present in Mycobacterium tuberculosis. This test is performed in a microbiology laboratory and tests for the presence of Mycobacterium tuberculosis in sputum, plus genes associated with drug resistance. | Other | Enrolled subjects |
| SpirometryAlso: Lung functionParticipants will be asked to blow into a spirometer to measure how much air they can expel in one second and in a whole breath. This will be repeated six times (three times before inhaling 3.5% saline solution and three times five minutes after breathing 3.5% saline solution). The results will be used to identify those whose airways are sensitive to the solution and to look for the presence of airways disease (asthma or chronic obstructive pulmonary disease). | Procedure or surgery | Enrolled subjects |
Primary outcome
Number of cases of active tuberculosis disease
Time frame: 1 year
Number of cases of active TB disease amongst the enrolled subjects, defined by the number of participants with X ray changes consistent with active tuberculosis and/or sputum culture positive for Mycobacterium tuberculosis with symptoms consistent with tuberculosis disease.
Number of cases of subclinical tuberculosis
Time frame: 1 year
Number of cases of subclinical tuberculosis amongst the enrolled subjects, defined by the number of participants with sputum culture positive for Mycobacterium tuberculosis, with or without X ray changes consistent with active tuberculosis and without symptoms consistent with tuberculosis disease.
Number of cases latent tuberculosis infection
Time frame: 1 year
Number of cases of latent tuberculosis infection amongst the enrolled subjects, defined by the number of participants with with positive tuberculin skin test (TST) and/or interferon gamma release assay (IGRA) (for latent TB infection), but without a history of previous, treated tuberculosis disease and without symptoms, X ray changes consistent with active tuberculosis disease or sputum culture positive for Mycobacterium tuberculosis.
7 secondary outcomes
Number with subsequent active TB disease
Time frame: 20 years
Time to subsequent active TB disease
Time frame: 20 years
Number of participants with a diagnosis of airways disease in an HIV infected cohort
Time frame: 2 years
Quality of life scores for those with HIV infection with or without TB infection.
Time frame: 2 years
Uptake of latent TB preventive treatment in an HIV clinic cohort
Time frame: 2 years
Cost of latent TB preventive treatment in an HIV clinic cohort
Time frame: 2 years
Number of adverse events for each participant taking latent TB preventive treatment
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- 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.
Marc Lipman, MD principal investigator
Clinical Senior Lecturer and Consultant Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Latent Tuberculosis, run by University College, London at 1 site in United Kingdom.
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 2 inclusion and 7 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 31 May 2017. 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 United Kingdom. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of active tuberculosis disease (time frame: 1 year). The study lists 3 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 31 May 2017.