Study of immediate versus deferred antiretroviral therapy in human immunodeficiency virus-associated tuberculous meningitis

Not Applicable

Completed

• Conditions: HIV-associated tuberculous meningitis; Infections and Infestations; Tuberculous meningitis

• Registration Number: ISRCTN63659091
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21596680

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-22
• Study Completion: 2008-12-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

1. Patients aged 15 or over
2. HIV seropositive
3. Anti-retroviral naive
4. Presenting with tuberculous meningitis

Exclusion Criteria

1. Positive Cerebrospinal Fluid (CSF) Gram or India ink stain
2. Known or suspected pregnancy
3. Anti-tuberculous treatment eight to 30 days immediately prior to recruitment
4. Previous antiretroviral therapy
5. Laboratory contraindications to anti-retroviral or anti-tuberculous therapy
6. Lack of consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at 9 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Mortality at 12 months<br> 2. Fever clearance time<br> 3. Coma clearance time<br> 4. Neurological relapse<br> 5. Progression to new or recurrent Acquired Immuno-Deficiency Syndrome (AIDS) defining illness<br> 6. Any grade three or four adverse event<br> 7. CD4 count response<br> 8. Plasma HIV-1 RiboNucleic Acid (RNA) response<br> 9. Neurological disability: neurological disability will be assessed using the 'simple questions' and Rankin score<br>