HIV, Acquired Immunodeficiency Syndrome (AIDS) Infections and Infestations Human Immunodeficiency Virus (HIV)
Conditions
Interventions
1. Chemoprophylaxis with isoniazid plus monitoring
2. Monitoring alone
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV infection; 2. Aged 13 or more including women of child bearing age 3. Are considered at increased risk of developing TB 4. At any stage of HIV disease except with a past or current diagnosis of TB 5. Are considered likely to survive for more than 3 months 6. Able to comply and give informed consent
Exclusion criteria
Exclusion criteria: 1. Women in first trimester of pregnancy 2. Prior or current diagnosis of TB or treatment with an anti TB drugs 3. Signs or symptoms suggesting TB where TB has not been excluded by CXR and three negative sputum smears 4. Close contacts of known cases of pulmonary TB where the clinician feels that isoniazid prophylaxis is indicated 5. Pre-existing disease which contraindicates treatment with isoniazid (such as grade 2 or worse peripheral neuropathy, liver disease, renal disease or alcoholism) or ALT or AST above 3x local upper limit of normal (ULN) or alkaline phosphatase above 5x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint - the development of TB requiring treatment whether: 1. Conformed on culture 2. Presumptive, based on smear or histological results 3. Diagnosed clinically only (including response to treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: 1. All cause mortality 2. Compliance (pill counts, urine tests for isoniazid) 3. Progression to new (non-recurrent) AIDS events | — |
Countries
United Kingdom
Outcome results
None listed