Condition category
Infections and Infestations
Date applied
21/03/2006
Date assigned
19/06/2006
Last edited
27/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://ctr.gsk.co.uk/summary/abacavir/III_CNAB3001.pdf

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 measures

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

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

http://www.gsk.com

Funders

Funder type

Industry

Funder name

GlaxoSmithKline

Alternative name(s)

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

Results - basic reporting

Publication summary

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11371689

Publication citations

  1. 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.

Additional files

Editorial Notes