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ISRCTN
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ISRCTN63659091
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ClinicalTrials.gov identifier
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NCT00433719
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Public title
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Study of immediate versus deferred antiretroviral therapy in human immunodeficiency virus-associated tuberculous meningitis
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Scientific title
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Acronym
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DK Study
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Serial number at source
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076224; OXTREC 023-04
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Study hypothesis
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Human Immunodeficiency Virus (HIV) infection is associated with an increased risk of Tuberculosis (TB); in particular Tuberculous Meningitis (TBM). There are limited data describing the influence of HIV infection on the clinical presentation, response to treatment, frequency of adverse events, outcome, or the impact of Anti-Retroviral Therapy (ART) in HIV-associated TBM. The optimal time to initiate ART is unknown. There are concerns that immediate ART may worsen rather than improve outcome, because of the development of an Immune Reconstitution Inflammatory Syndrome (IRIS) or combined drug toxicities. Conversely, delaying ART may result in increased HIV-related deaths. We therefore propose to conduct a clinical trial of immediate versus deferred ART in HIV-infected patients presenting with TBM, to assess effect on survival.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Viet Nam
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Disease/condition/study domain
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HIV-associated tuberculous meningitis
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Participants - inclusion criteria
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1. Patients aged 15 or over
2. HIV seropositive
3. Anti-retroviral naive
4. Presenting with tuberculous meningitis
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Participants - exclusion criteria
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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
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Anticipated start date
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01/06/2005
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Anticipated end date
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01/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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222 - recruitment ends on 20/09/2007
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Interventions
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Randomised double-blind placebo-controlled trial with two parallel arms: immediate Highly Active Anti-Retroviral Therapy (HAART) and deferred HAART (two months). Patients will also receive standard treatment (anti-tuberculous chemotherapy and adjunctive dexamethasone) for tuberculous meningitis.
As of 13th February 2007 the anticipated end date of this trial was shortened to 20th September 2008.
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Primary outcome measure(s)
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Mortality at nine months
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Secondary outcome measure(s)
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1. Mortality at 12 months
2. Fever clearance time
3. Coma clearance time
4. Neurological relapse
5. Progression to new or recurrent Acquired Immuno-Deficiency Syndrome (AIDS) defining illness
6. Any grade three or four adverse event
7. CD4 count response
8. Plasma HIV-1 RiboNucleic Acid (RNA) response
9. Neurological disability: neurological disability will be assessed using the 'simple questions' and Rankin score
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 076224)
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Trial website
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Publications
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Contact name
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Dr
Estee
Torok
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Address
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Oxford University Clinical Research Unit
Hospital for Tropical Diseases
190 Ben Ham Tu
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City/town
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Ho Chi Minh City
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Zip/Postcode
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District 5
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Country
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Viet Nam
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Date applied
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18/04/2005
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Last edited
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24/08/2007
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Date ISRCTN assigned
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22/07/2005
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