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 number	NCT00002163
Secondary identifying numbers	CNAB 3001

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

Study website

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

Study design	Randomised, double-blind, placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	1592U89 (Abacavir)
Primary outcome measure	Improvement in neuropsychological performance.
Secondary outcome measures	Reduction in cerebrospinal fluid HIV viral load.
Overall study start date	03/09/1996
Completion date	08/01/1998

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Australia
Canada
United Kingdom
United States of America

Study participating centre

Department of Neurology

Sydney
2010
Australia

Sponsor information

GlaxoSmithKline (UK)
Industry

Stockley Park West
Uxbridge
Middlesex
UB11 1BT
United Kingdom

Phone	+44 (0)208 9909000
Email	carolyn.2.goodwin@gsk.com
Website	http://www.gsk.com
"ROR"	https://ror.org/01xsqw823

Funders

Funder type

Industry

GlaxoSmithKline
Government organisation / For-profit companies (industry)

Alternative name(s): GlaxoSmithKline plc., GSK plc., GSK
Location: United Kingdom

NIH grants: NS44807 (McArthur JC) and NS094659 (McArthur JC)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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