Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Bruce Brew
ORCID ID
Contact details
Department of Neurology
Level 4 Xavier
St Vincent's Hospital
Sydney
2010
Australia
+61 (0)2 8382 4100
b.brew@unsw.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002163
Protocol/serial number
CNAB 3001
Study information
Scientific title
Acronym
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
HIV-1 infection with AIDS dementia
Intervention
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.
Intervention type
Drug
Phase
Phase III
Drug names
1592U89 (Abacavir)
Primary outcome measure
Improvement in neuropsychological performance.
Secondary outcome measures
Reduction in cerebrospinal fluid HIV viral load.
Overall trial start date
03/09/1996
Overall trial end date
08/01/1998
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
Subjects with evidence of confounding neurological disease or presenting with other central nervous system (CNS) opportunistic infections or neoplasms were excluded
Recruitment start date
03/09/1996
Recruitment end date
08/01/1998
Locations
Countries of recruitment
Australia, Canada, United Kingdom, United States of America
Trial participating centre
Department of Neurology
Sydney
2010
Australia
Sponsor information
Organisation
GlaxoSmithKline (UK)
Sponsor details
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom
+44 (0)208 9909000
carolyn.2.goodwin@gsk.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Funder name
NIH grants: NS44807 (McArthur JC) and NS094659 (McArthur JC)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11371689
Publication citations
-
Results
Lanier ER, Sturge G, McClernon D, Brown S, Halman M, Sacktor N, McArthur J, Atkinson JH, Clifford D, Price RW, Simpson D, Torres G, Catalan J, Marder K, Power C, Hall C, Romero C, Brew B, HIV-1 reverse transcriptase sequence in plasma and cerebrospinal fluid of patients with AIDS dementia complex treated with Abacavir., AIDS, 2001, 15, 6, 747-751.