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	https://doi.org/10.1186/ISRCTN53707238
ClinicalTrials.gov (NCT)	NCT00002163
Protocol serial number	CNAB 3001
Sponsor	GlaxoSmithKline (UK)
Funders	GlaxoSmithKline, NIH grants: NS44807 (McArthur JC) and NS094659 (McArthur JC)

Submission date: 21/03/2006
Registration date: 19/06/2006
Last edited: 27/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bruce Brew
Scientific

Department of Neurology
Level 4 Xavier
St Vincent's Hospital
Sydney
2010
Australia

Phone	+61 (0)2 8382 4100
Email	b.brew@unsw.edu.au

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	This study was reviewed and approved by Riverside Ethics Committee, Chelsea and Westminster Hospital on 05/12/1996, reference number: 1163
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	1592U89 (Abacavir)
Primary outcome measure(s)	Improvement in neuropsychological performance.
Key secondary outcome measure(s)	Reduction in cerebrospinal fluid HIV viral load.
Completion date	08/01/1998

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	90
Key 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
Key exclusion criteria	Subjects with evidence of confounding neurological disease or presenting with other central nervous system (CNS) opportunistic infections or neoplasms were excluded
Date of first enrolment	03/09/1996
Date of final enrolment	08/01/1998

Locations

Countries of recruitment

United Kingdom
Australia
Canada
United States of America

Study participating centre

Department of Neurology

Sydney
2010
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/04/2001		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes