HIV Clinical Trial
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
Verified date | May 2017 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | September 2024 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - New diagnosis of HIV or established in care in HIV clinic by stratified sampling - Able to give informed consent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Ian Charleson Centre, Royal Free Hospital | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Primary | 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. | 1 year | |
Primary | 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. | 1 year | |
Secondary | Number with subsequent active TB disease | Number of participants that develop new TB disease after the testing period has taken place | 20 years | |
Secondary | Time to subsequent active TB disease | Time (months) from when testing took place to subsequent active TB disease in those that develop it. | 20 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years | |
Secondary | 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. | 2 years |
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