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ISRCTN
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ISRCTN53707238
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DOI
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10.1186/ISRCTN53707238
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ClinicalTrials.gov identifier
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NCT00002163
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EudraCT number
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Public title
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A Phase III randomised, double-blind, multicentre study to evaluate the safety and efficacy of 1592U89 (abacavir) in human immunodeficiency virus 1-infected patients with aquired immune deficiency syndrome dementia complex
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Scientific title
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Acronym
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N/A
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Serial number at source
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CNAB 3001
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Study hypothesis
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The addition of abacavir to an antiretroviral regimen in patients with aquired immune deficiency syndrome (AIDS) dementia will lead to improved neuropsychological performance
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Lay summary
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Not provided at time of registration
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Ethics approval
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This study was reviewed and approved by Riverside Ethics Committee, Chelsea and Westminster Hospital on 05/12/1996, reference number: 1163
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Study design
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Randomised, double-blind, placebo-controlled study
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Countries of recruitment
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Australia, Canada, United Kingdom, United States of America
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Disease/condition/study domain
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HIV-1 infection with AIDS dementia
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Participants - inclusion criteria
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Confirmed human immunodeficiency virus-1 (HIV-1) seropositive male or female subjects, aged 18 to 65 years, diagnosed with stage 1 or 2 (mild to moderate) AIDS dementia complex and stable on current antiretroviral therapy for a minimum of eight weeks prior to study entry were enrolled. Subjects were impaired by at least 1.5 standard deviations (SDs) below normal in at least two neuropsychological domains from the neuropsychological test battery
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Participants - exclusion criteria
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Subjects with evidence of confounding neurological disease or presenting with other central nervous system (CNS) opportunistic infections or neoplasms were excluded
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Anticipated start date
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03/09/1996
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Anticipated end date
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08/01/1998
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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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90
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Interventions
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Subjects were pre-stratified into group A or B depending on whether their respective existing therapy contained zidovudine (ZDV) or not.
Subjects receiving stavudine (d4T) were stratified into group B. Study participants were randomized within each stratum to receive either 600 mg of abacavir (ABC) or matched placebo every twelve hours in addition to their current antiretroviral therapy for the first 12 weeks of the study.
At the end of the randomized phase or at the time of AIDS dementia complex (ADC) progression, or severe antiretroviral drug toxicity not related to ABC, there was the option of continuing the study further for 40 weeks receiving open label ABC.
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Primary outcome measure(s)
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Improvement in neuropsychological performance.
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Secondary outcome measure(s)
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Reduction in cerebrospinal fluid HIV viral load.
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Sources of funding
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1. GlaxoSmithKline
2. NIH grants: NS44807 (McArthur JC) and NS094659 (McArthur JC)
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Trial website
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http://ctr.gsk.co.uk/summary/abacavir/III_CNAB3001.pdf
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Publications
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2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11371689
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Contact name
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Prof
Bruce
Brew
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Address
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Department of Neurology
Level 4 Xavier
St Vincent's Hospital
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City/town
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Sydney
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Zip/Postcode
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2010
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Country
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Australia
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Tel
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+61 (0)2 8382 4100
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Fax
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+61 (0)2 8382 4101
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Email
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b.brew@unsw.edu.au
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Sponsor
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GlaxoSmithKline (UK)
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Address
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Stockley Park West
Uxbridge
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City/town
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Middlesex
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Zip/Postcode
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UB11 1BT
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Country
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United Kingdom
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Tel
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+44 (0)208 9909000
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Fax
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+44 (0)208 9904321
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Email
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carolyn.2.goodwin@gsk.com
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Sponsor website:
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http://www.gsk.com
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Date applied
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21/03/2006
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Last edited
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27/09/2012
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Date ISRCTN assigned
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19/06/2006
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