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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
ISRCTN ISRCTN53707238
DOI 10.1186/ISRCTN53707238
ClinicalTrials.gov identifier NCT00002163
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source CNAB 3001
Study hypothesis The addition of abacavir to an antiretroviral regimen in patients with aquired immune deficiency syndrome (AIDS) dementia will lead to improved neuropsychological performance
Lay summary Not provided at time of registration
Ethics approval This study was reviewed and approved by Riverside Ethics Committee, Chelsea and Westminster Hospital on 05/12/1996, reference number: 1163
Study design Randomised, double-blind, placebo-controlled study
Countries of recruitment Australia, Canada, United Kingdom, United States of America
Disease/condition/study domain HIV-1 infection with AIDS dementia
Participants - inclusion criteria 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
Participants - exclusion criteria Subjects with evidence of confounding neurological disease or presenting with other central nervous system (CNS) opportunistic infections or neoplasms were excluded
Anticipated start date 03/09/1996
Anticipated end date 08/01/1998
Status of trial Completed
Patient information material
Target number of participants 90
Interventions 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.
Primary outcome measure(s) Improvement in neuropsychological performance.
Secondary outcome measure(s) Reduction in cerebrospinal fluid HIV viral load.
Sources of funding 1. GlaxoSmithKline
2. NIH grants: NS44807 (McArthur JC) and NS094659 (McArthur JC)
Trial website http://ctr.gsk.co.uk/summary/abacavir/III_CNAB3001.pdf
Publications 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11371689
Contact name Prof  Bruce  Brew
  Address Department of Neurology
Level 4 Xavier
St Vincent's Hospital
  City/town Sydney
  Zip/Postcode 2010
  Country Australia
  Tel +61 (0)2 8382 4100
  Fax +61 (0)2 8382 4101
  Email b.brew@unsw.edu.au
Sponsor GlaxoSmithKline (UK)
  Address Stockley Park West
Uxbridge
  City/town Middlesex
  Zip/Postcode UB11 1BT
  Country United Kingdom
  Tel +44 (0)208 9909000
  Fax +44 (0)208 9904321
  Email carolyn.2.goodwin@gsk.com
  Sponsor website: http://www.gsk.com
Date applied 21/03/2006
Last edited 27/09/2012
Date ISRCTN assigned 19/06/2006
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