Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00340080




Registration number
NCT00340080
Ethics application status
Date submitted
19/06/2006
Date registered
21/06/2006
Date last updated
25/01/2010

Titles & IDs
Public title
Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity
Scientific title
A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*5701) for Susceptibility to Abacavir Hypersensitivity
Secondary ID [1] 0 0
PREDICT-1
Secondary ID [2] 0 0
CNA106030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of clinically-suspected ABC HSR during the 6-week observation period. Incidence of immunologically-confirmed ABC HSR. The clinical diagnosis of which occurs over the 6-week observation period.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Incidence of clinically-suspected ABC HSR in Caucasians and in different ethnic sub-groups. Sensitivity and specificity, positive and negative predictive value of genetic screening for HLA-B*5701 for susceptibility of HSR.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria:

* Infected with documented HIV-1.
* Subjects are Abacavir-naive (subjects can be antiretroviral therapy (ART)-naive or experienced).
* All subjects must have a clinical need for treatment with Abacavir (ABC) or an ABC-containing product that precedes the decision to participate in the study.
* If subjects are therapy naive they must meet the criteria for commencing HAART according to local guidelines.
* ABC and ABC-containing products are not recommended during pregnancy. A female is eligible to enter and participate in the study if she is of:

1. Non-child-bearing potential: women who are surgically sterile or post-menopausal, the latter indicated by history of no menses for a minimum of 1 year from the date of the screening visit.
2. Child-bearing potential: women who provide a negative pregnancy test (beta-human chorionic gonadotrophin; beta-HCG) at Screening and who agree to one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician, during the study period and through epicutaneous patch testing where appropriate):
* Complete abstinence from intercourse from 4 weeks prior to administration of the ABC-containing compound, throughout the study, and for at least 4 weeks after discontinuation of ABC or ABC-containing product.
* Double barrier method (e.g., male condom/spermicide, male condom/diaphragm, diaphragm/spermicide). Hormonal contraceptives will not be considered sufficient forms of contraception for this study.
* Any intrauterine device with published data showing that the expected failure rate is <1% per year.
* Sterilisation (male partner of female subject).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Has previously received ABC-containing therapy.
* Satisfies any contraindications or restrictions to ABC therapy as listed in the product labels. Treatment with ABC must be in line with the recommendations of the product label.
* The subject or any of their healthcare providers is aware of the subjects HLA type.
* Has undergone an allogeneic bone marrow transplant.
* Has an active or acute CDC Clinical Category C event at screening. Treatment for the acute event must have been completed at least 30 days prior to Screening.
* Current severe illness, including liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for the study.
* Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject's participation in the study.
* Pregnant women or women who are breastfeeding.
* Any immunisation within 30 days prior to Day 1.
* Subject is, in the opinion of the Investigator, unable to complete the 6 week Observation period and the EPT assessments as required.
* Subject requires treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to Screening, or has an anticipated need for these agents within the study period.
* Subject is enrolled in one or more investigational drug/vaccine protocols.
* In France, an eligible subject is neither affiliated with nor a beneficiary of a social security category.
* A subject will not be eligible for progression to Baseline (Day 1) if any of the following criteria apply:
* A positive result for HLA-B*5701 in those subjects randomised to the genetic screening arm.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Miami
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4220 - Miami
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Austria
State/province [5] 0 0
Vienna
Country [6] 0 0
Belgium
State/province [6] 0 0
Brugge
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussel
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Liege
Country [13] 0 0
France
State/province [13] 0 0
Aix En Provence
Country [14] 0 0
France
State/province [14] 0 0
Amiens
Country [15] 0 0
France
State/province [15] 0 0
Angers
Country [16] 0 0
France
State/province [16] 0 0
Annecy
Country [17] 0 0
France
State/province [17] 0 0
Avignon
Country [18] 0 0
France
State/province [18] 0 0
Besançon
Country [19] 0 0
France
State/province [19] 0 0
Bobigny Cedex
Country [20] 0 0
France
State/province [20] 0 0
Bondy
Country [21] 0 0
France
State/province [21] 0 0
Bordeaux Cedex
Country [22] 0 0
France
State/province [22] 0 0
Bordeaux
Country [23] 0 0
France
State/province [23] 0 0
Caen
Country [24] 0 0
France
State/province [24] 0 0
Cannes
Country [25] 0 0
France
State/province [25] 0 0
Clermont-Ferrand
Country [26] 0 0
France
State/province [26] 0 0
Corbeil Essonnes Cedex
Country [27] 0 0
France
State/province [27] 0 0
Créteil
Country [28] 0 0
France
State/province [28] 0 0
Dijon
Country [29] 0 0
France
State/province [29] 0 0
Fréjus
Country [30] 0 0
France
State/province [30] 0 0
Grenoble
Country [31] 0 0
France
State/province [31] 0 0
La Roche Sur Yon Cedex 9
Country [32] 0 0
France
State/province [32] 0 0
La Rochelle
Country [33] 0 0
France
State/province [33] 0 0
Le Kremlin Bicêtre Cedex
Country [34] 0 0
France
State/province [34] 0 0
Levallois-Perret
Country [35] 0 0
France
State/province [35] 0 0
Lyon Cedex 03
Country [36] 0 0
France
State/province [36] 0 0
Marseille Cedex 08
Country [37] 0 0
France
State/province [37] 0 0
Marseille
Country [38] 0 0
France
State/province [38] 0 0
Metz
Country [39] 0 0
France
State/province [39] 0 0
Montpellier Cedex 5
Country [40] 0 0
France
State/province [40] 0 0
Mulhouse
Country [41] 0 0
France
State/province [41] 0 0
Nantes
Country [42] 0 0
France
State/province [42] 0 0
Nice
Country [43] 0 0
France
State/province [43] 0 0
Nimes Cedex 9
Country [44] 0 0
France
State/province [44] 0 0
Niort
Country [45] 0 0
France
State/province [45] 0 0
Orléans
Country [46] 0 0
France
State/province [46] 0 0
Paris Cedex 10
Country [47] 0 0
France
State/province [47] 0 0
Paris Cedex 13
Country [48] 0 0
France
State/province [48] 0 0
Paris Cedex 14
Country [49] 0 0
France
State/province [49] 0 0
Paris Cedex 20
Country [50] 0 0
France
State/province [50] 0 0
Paris
Country [51] 0 0
France
State/province [51] 0 0
Perpignan
Country [52] 0 0
France
State/province [52] 0 0
Poitiers
Country [53] 0 0
France
State/province [53] 0 0
Quimper
Country [54] 0 0
France
State/province [54] 0 0
Reims
Country [55] 0 0
France
State/province [55] 0 0
Rennes Cedex 09
Country [56] 0 0
France
State/province [56] 0 0
Rouen
Country [57] 0 0
France
State/province [57] 0 0
Saint Brieuc
Country [58] 0 0
France
State/province [58] 0 0
Saint Denis Cedex 01
Country [59] 0 0
France
State/province [59] 0 0
Saint-Etienne
Country [60] 0 0
France
State/province [60] 0 0
Saint-Germain-en-Laye Cedex
Country [61] 0 0
France
State/province [61] 0 0
Strasbourg
Country [62] 0 0
France
State/province [62] 0 0
Toulouse
Country [63] 0 0
France
State/province [63] 0 0
Tourcoing
Country [64] 0 0
France
State/province [64] 0 0
Tours
Country [65] 0 0
France
State/province [65] 0 0
Troyes
Country [66] 0 0
France
State/province [66] 0 0
Valence
Country [67] 0 0
France
State/province [67] 0 0
Valenciennes
Country [68] 0 0
France
State/province [68] 0 0
Villejuif Cedex
Country [69] 0 0
Germany
State/province [69] 0 0
Baden-Wuerttemberg
Country [70] 0 0
Germany
State/province [70] 0 0
Bayern
Country [71] 0 0
Germany
State/province [71] 0 0
Hessen
Country [72] 0 0
Germany
State/province [72] 0 0
Niedersachsen
Country [73] 0 0
Germany
State/province [73] 0 0
Nordrhein-Westfalen
Country [74] 0 0
Germany
State/province [74] 0 0
Rheinland-Pfalz
Country [75] 0 0
Germany
State/province [75] 0 0
Sachsen-Anhalt
Country [76] 0 0
Germany
State/province [76] 0 0
Sachsen
Country [77] 0 0
Germany
State/province [77] 0 0
Schleswig-Holstein
Country [78] 0 0
Germany
State/province [78] 0 0
Berlin
Country [79] 0 0
Germany
State/province [79] 0 0
Hamburg
Country [80] 0 0
Ireland
State/province [80] 0 0
Dublin
Country [81] 0 0
Israel
State/province [81] 0 0
Kfar Saba
Country [82] 0 0
Israel
State/province [82] 0 0
Ramat Gan
Country [83] 0 0
Israel
State/province [83] 0 0
Rehovot
Country [84] 0 0
Israel
State/province [84] 0 0
Tel-Aviv
Country [85] 0 0
Italy
State/province [85] 0 0
Calabria
Country [86] 0 0
Italy
State/province [86] 0 0
Campania
Country [87] 0 0
Italy
State/province [87] 0 0
Emilia-Romagna
Country [88] 0 0
Italy
State/province [88] 0 0
Lazio
Country [89] 0 0
Italy
State/province [89] 0 0
Liguria
Country [90] 0 0
Italy
State/province [90] 0 0
Lombardia
Country [91] 0 0
Italy
State/province [91] 0 0
Marche
Country [92] 0 0
Italy
State/province [92] 0 0
Piemonte
Country [93] 0 0
Italy
State/province [93] 0 0
Puglia
Country [94] 0 0
Italy
State/province [94] 0 0
Sardegna
Country [95] 0 0
Italy
State/province [95] 0 0
Sicilia
Country [96] 0 0
Italy
State/province [96] 0 0
Toscana
Country [97] 0 0
Italy
State/province [97] 0 0
Trentino-Alto Adige
Country [98] 0 0
Italy
State/province [98] 0 0
Veneto
Country [99] 0 0
Latvia
State/province [99] 0 0
Riga
Country [100] 0 0
Netherlands
State/province [100] 0 0
Alkmaar
Country [101] 0 0
Netherlands
State/province [101] 0 0
Amsterdam
Country [102] 0 0
Netherlands
State/province [102] 0 0
Arnhem
Country [103] 0 0
Netherlands
State/province [103] 0 0
Den Haag
Country [104] 0 0
Netherlands
State/province [104] 0 0
Enschede
Country [105] 0 0
Netherlands
State/province [105] 0 0
Groningen
Country [106] 0 0
Netherlands
State/province [106] 0 0
Nijmegen
Country [107] 0 0
Netherlands
State/province [107] 0 0
Rotterdam
Country [108] 0 0
Netherlands
State/province [108] 0 0
Tilburg
Country [109] 0 0
Netherlands
State/province [109] 0 0
Vlissingen
Country [110] 0 0
Netherlands
State/province [110] 0 0
Zwolle
Country [111] 0 0
Norway
State/province [111] 0 0
Fredrikstad
Country [112] 0 0
Norway
State/province [112] 0 0
Oslo
Country [113] 0 0
Poland
State/province [113] 0 0
Bydgoszcz
Country [114] 0 0
Poland
State/province [114] 0 0
Chorzow
Country [115] 0 0
Poland
State/province [115] 0 0
Szczecin
Country [116] 0 0
Poland
State/province [116] 0 0
Warszawa
Country [117] 0 0
Portugal
State/province [117] 0 0
Almada
Country [118] 0 0
Portugal
State/province [118] 0 0
Amadora
Country [119] 0 0
Portugal
State/province [119] 0 0
Aveiro
Country [120] 0 0
Portugal
State/province [120] 0 0
Cascais
Country [121] 0 0
Portugal
State/province [121] 0 0
Lisboa
Country [122] 0 0
Portugal
State/province [122] 0 0
Monte Funchal
Country [123] 0 0
Portugal
State/province [123] 0 0
Ponta Delgada
Country [124] 0 0
Portugal
State/province [124] 0 0
Porto
Country [125] 0 0
Romania
State/province [125] 0 0
Bucharest
Country [126] 0 0
Romania
State/province [126] 0 0
Constanta
Country [127] 0 0
Romania
State/province [127] 0 0
Iasi
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Barnaul
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Belgorod
Country [130] 0 0
Russian Federation
State/province [130] 0 0
Krasnodar
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Lipetsk
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Moscow
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Murmansk
Country [134] 0 0
Russian Federation
State/province [134] 0 0
N.Novgorod
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Orel
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Perm
Country [137] 0 0
Russian Federation
State/province [137] 0 0
Ryazan
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Saint-Petersburg
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Samara
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Saratov
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Smolensk
Country [142] 0 0
Russian Federation
State/province [142] 0 0
St. Petersburg
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Volgograd
Country [144] 0 0
Slovenia
State/province [144] 0 0
Ljubljana
Country [145] 0 0
Spain
State/province [145] 0 0
Alcala de Henares
Country [146] 0 0
Spain
State/province [146] 0 0
Alicante
Country [147] 0 0
Spain
State/province [147] 0 0
Badalona
Country [148] 0 0
Spain
State/province [148] 0 0
Baracaldo/Vizcaya
Country [149] 0 0
Spain
State/province [149] 0 0
Barcelona
Country [150] 0 0
Spain
State/province [150] 0 0
Bilbao
Country [151] 0 0
Spain
State/province [151] 0 0
Calella
Country [152] 0 0
Spain
State/province [152] 0 0
Córdoba
Country [153] 0 0
Spain
State/province [153] 0 0
Elche (Alicante)
Country [154] 0 0
Spain
State/province [154] 0 0
Granada
Country [155] 0 0
Spain
State/province [155] 0 0
La Coruña
Country [156] 0 0
Spain
State/province [156] 0 0
Madrid
Country [157] 0 0
Spain
State/province [157] 0 0
Malaga
Country [158] 0 0
Spain
State/province [158] 0 0
Marid
Country [159] 0 0
Spain
State/province [159] 0 0
Mataro
Country [160] 0 0
Spain
State/province [160] 0 0
Oviedo
Country [161] 0 0
Spain
State/province [161] 0 0
Reus
Country [162] 0 0
Spain
State/province [162] 0 0
San Sebastián
Country [163] 0 0
Spain
State/province [163] 0 0
Santander
Country [164] 0 0
Spain
State/province [164] 0 0
Sevilla
Country [165] 0 0
Spain
State/province [165] 0 0
Tarragona
Country [166] 0 0
Spain
State/province [166] 0 0
Valencia
Country [167] 0 0
Spain
State/province [167] 0 0
Vigo ( Pontevedra)
Country [168] 0 0
Spain
State/province [168] 0 0
Vitoria
Country [169] 0 0
Switzerland
State/province [169] 0 0
Basel
Country [170] 0 0
Switzerland
State/province [170] 0 0
Bruderholz
Country [171] 0 0
Switzerland
State/province [171] 0 0
La Chaux-de-Fonds
Country [172] 0 0
Switzerland
State/province [172] 0 0
Lausanne
Country [173] 0 0
Switzerland
State/province [173] 0 0
Lugano
Country [174] 0 0
Switzerland
State/province [174] 0 0
St Gallen
Country [175] 0 0
Switzerland
State/province [175] 0 0
Zurich
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Derbyshire
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Lancashire
Country [178] 0 0
United Kingdom
State/province [178] 0 0
London
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Nottinghamshire
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Staffordshire
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Belfast
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Birmingham
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Coventry
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Dudley, Birmingham
Country [185] 0 0
United Kingdom
State/province [185] 0 0
East Yorkshire
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Farnworth, Bolton
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Glasgow
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Gloucester
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Leicester
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Middlesborough
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Plaistow, London
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MB BS MRCP FFPM
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00340080