Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00340080
First received: June 19, 2006
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

Study to evaluate the utility of prospective HLA-B*5701 screening on the incidence of abacavir hypersensitivity (ABC HSR) in 1800 previously ABC-naive adults with HIV-1 from Europe, Australia and other countries as applicable. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*5701 prior to ABC-containing HAART results in a lower incidence of clinically-suspected HSR versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*5701 prior to ABC-containing HAART, results in a significantly lower incidence of immunologically-confirmed HSR versus current standard of care (no genetic screening or patch testing). The study consists of up to a 28-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected ABC HSR and a subset of ABC-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening). Subjects identified as HLA-B*5701 positive in the prospective Genetic Screening Arm will not receive ABC and will be excluded from further study. Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.


Condition Intervention Phase
HIV Infection
Drug: Abacavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 1806
Study Start Date: April 2006
Intervention Details:
    Drug: Abacavir
    Other Name: Abacavir
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340080

  Hide Study Locations
Locations
Australia, New South Wales
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
GSK Investigational Site
Miami, Queensland, Australia, 4220
Austria
GSK Investigational Site
Graz, Austria, A-8020
GSK Investigational Site
Innsbruck, Austria, A-6020
GSK Investigational Site
Linz, Austria, A-4020
GSK Investigational Site
Salzburg, Austria, A-5020
GSK Investigational Site
Vienna, Austria, A-1090
Belgium
GSK Investigational Site
Brugge, Belgium, 8000
GSK Investigational Site
Brussel, Belgium, 1090
GSK Investigational Site
Brussels, Belgium, 1070
GSK Investigational Site
Bruxelles, Belgium, 1000
GSK Investigational Site
Bruxelles, Belgium, 1050
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liege, Belgium, 4000
France
GSK Investigational Site
Aix En Provence, France, 13616
GSK Investigational Site
Amiens, France, 80054
GSK Investigational Site
Angers, France, 49000
GSK Investigational Site
Annecy, France, 74011
GSK Investigational Site
Avignon, France, 84000
GSK Investigational Site
Besançon, France, 25030
GSK Investigational Site
Bobigny Cedex, France, 93009
GSK Investigational Site
Bondy, France, 93143
GSK Investigational Site
Bordeaux, France, 33000
GSK Investigational Site
Bordeaux Cedex, France, 33076
GSK Investigational Site
Caen, France, 14000
GSK Investigational Site
Cannes, France, 06401
GSK Investigational Site
Clermont-Ferrand, France, 63058
GSK Investigational Site
Corbeil Essonnes Cedex, France, 91106
GSK Investigational Site
Créteil, France, 94010
GSK Investigational Site
Dijon, France, 21079
GSK Investigational Site
Fréjus, France, 83608
GSK Investigational Site
Grenoble, France, 38043
GSK Investigational Site
La Roche Sur Yon Cedex 9, France, 85025
GSK Investigational Site
La Rochelle, France, 17019
GSK Investigational Site
Le Kremlin Bicêtre Cedex, France, 94275
GSK Investigational Site
Levallois-Perret, France, 92300
GSK Investigational Site
Lyon Cedex 03, France, 69437
GSK Investigational Site
Marseille, France, 13915
GSK Investigational Site
Marseille, France, 13274
GSK Investigational Site
Marseille, France, 13006
GSK Investigational Site
Marseille, France, 13005
GSK Investigational Site
Marseille Cedex 08, France, 13285
GSK Investigational Site
Metz, France, 57000
GSK Investigational Site
Montpellier Cedex 5, France, 34295
GSK Investigational Site
Mulhouse, France, 68000
GSK Investigational Site
Nantes, France, 44093
GSK Investigational Site
Nice, France, 06202
GSK Investigational Site
Nimes Cedex 9, France, 30029
GSK Investigational Site
Niort, France, 79021
GSK Investigational Site
Orléans, France, 45100
GSK Investigational Site
Paris, France, 75014
GSK Investigational Site
Paris, France, 75018
GSK Investigational Site
Paris Cedex 10, France, 75475
GSK Investigational Site
Paris Cedex 13, France, 75651
GSK Investigational Site
Paris Cedex 14, France, 75679
GSK Investigational Site
Paris Cedex 20, France, 75970
GSK Investigational Site
Perpignan, France, 66046
GSK Investigational Site
Poitiers, France, 86021
GSK Investigational Site
Quimper, France, 29107
GSK Investigational Site
Reims, France, 51092
GSK Investigational Site
Rennes Cedex 09, France, 35033
GSK Investigational Site
Rouen, France, 76030
GSK Investigational Site
Saint Brieuc, France, 22023
GSK Investigational Site
Saint Denis Cedex 01, France, 93205
GSK Investigational Site
Saint-Etienne, France, 42055
GSK Investigational Site
Saint-Germain-en-Laye Cedex, France, 78100
GSK Investigational Site
Strasbourg, France, 67000
GSK Investigational Site
Toulouse, France, 31059
GSK Investigational Site
Tourcoing, France, 59208
GSK Investigational Site
Tours, France, 37044
GSK Investigational Site
Troyes, France, 10003
GSK Investigational Site
Valence, France, 26953
GSK Investigational Site
Valenciennes, France, 59300
GSK Investigational Site
Villejuif Cedex, France, 94804
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79098
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70197
GSK Investigational Site
Erlangen, Bayern, Germany, 91054
GSK Investigational Site
Fuerth, Bayern, Germany, 90762
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
GSK Investigational Site
Muenchen, Bayern, Germany, 80331
GSK Investigational Site
Muenchen, Bayern, Germany, 80801
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97080
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Osnabrueck, Niedersachsen, Germany, 49090
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48143
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39120
GSK Investigational Site
Leipzig, Sachsen, Germany, 04170
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24116
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 20095
GSK Investigational Site
Hamburg, Germany, 20146
GSK Investigational Site
Hamburg, Germany, 20246
Ireland
GSK Investigational Site
Dublin, Ireland, 8
Israel
GSK Investigational Site
Kfar Saba, Israel, 44281
GSK Investigational Site
Ramat Gan, Israel, 52621
GSK Investigational Site
Rehovot, Israel, 76100
GSK Investigational Site
Tel-Aviv, Israel, 64239
Italy
GSK Investigational Site
Catanzaro, Calabria, Italy, 88100
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Salerno, Campania, Italy, 84131
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40133
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy, 44100
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy, 29100
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
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Latina, Lazio, Italy, 04100
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Roma, Lazio, Italy, 00185
GSK Investigational Site
Roma, Lazio, Italy, 00161
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Genova, Liguria, Italy, 16132
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Sanremo (im), Liguria, Italy, 18032
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Bergamo, Lombardia, Italy, 24128
GSK Investigational Site
Brescia, Lombardia, Italy, 25125
GSK Investigational Site
Busto Arsizio (va), Lombardia, Italy, 21052
GSK Investigational Site
Cuggiono (mi), Lombardia, Italy, 20012
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Milano, Lombardia, Italy, 20142
GSK Investigational Site
Milano, Lombardia, Italy, 20157
GSK Investigational Site
Torrette Di Ancona (an), Marche, Italy, 60020
GSK Investigational Site
Asti, Piemonte, Italy, 14100
GSK Investigational Site
Pallanza (Verbania), Piemonte, Italy, 28921
GSK Investigational Site
Torino, Piemonte, Italy, 10149
GSK Investigational Site
Bari, Puglia, Italy, 70124
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Cagliari, Sardegna, Italy, 09121
GSK Investigational Site
Sassari, Sardegna, Italy, 71000
GSK Investigational Site
Catania, Sicilia, Italy, 95100
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Grosseto, Toscana, Italy, 58100
GSK Investigational Site
Bolzano, Trentino-Alto Adige, Italy, 39100
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Padova, Veneto, Italy, 35128
GSK Investigational Site
Treviso, Veneto, Italy, 31100
GSK Investigational Site
Vicenza, Veneto, Italy, 36100
Latvia
GSK Investigational Site
Riga, Latvia, LV1006
Netherlands
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Amsterdam, Netherlands, 1091 AC
GSK Investigational Site
Arnhem, Netherlands, 6815 AD
GSK Investigational Site
Den Haag, Netherlands, 2512 VA
GSK Investigational Site
Den Haag, Netherlands, 2545 CH
GSK Investigational Site
Enschede, Netherlands, 7511JX
GSK Investigational Site
Groningen, Netherlands, 9713 GZ
GSK Investigational Site
Nijmegen, Netherlands, 6525 GA
GSK Investigational Site
Rotterdam, Netherlands, 3078 HT
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
Tilburg, Netherlands, 5022 GC
GSK Investigational Site
Vlissingen, Netherlands, 4382 EE
GSK Investigational Site
Zwolle, Netherlands, 8025 AB
Norway
GSK Investigational Site
Fredrikstad, Norway, 1606
GSK Investigational Site
Oslo, Norway, 0450
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-030
GSK Investigational Site
Chorzow, Poland, 41-500
GSK Investigational Site
Szczecin, Poland, 71-455
GSK Investigational Site
Warszawa, Poland, 01-201
Portugal
GSK Investigational Site
Almada, Portugal, 2805 - 267
GSK Investigational Site
Amadora, Portugal, 2720-276
GSK Investigational Site
Aveiro, Portugal, 4814-501
GSK Investigational Site
Cascais, Portugal, 2750
GSK Investigational Site
Lisboa, Portugal, 1150-242
GSK Investigational Site
Monte Funchal, Portugal, 9054-535
GSK Investigational Site
Ponta Delgada, Portugal, 9500-270
GSK Investigational Site
Porto, Portugal, 4369-004
Romania
GSK Investigational Site
Bucharest, Romania, 021105
GSK Investigational Site
Constanta, Romania, 900709
GSK Investigational Site
Iasi, Romania, 700116
Russian Federation
GSK Investigational Site
Barnaul, Russian Federation, 656010
GSK Investigational Site
Belgorod, Russian Federation, 308036
GSK Investigational Site
Krasnodar, Russian Federation, 350015
GSK Investigational Site
Lipetsk, Russian Federation, 398043
GSK Investigational Site
Moscow, Russian Federation, 105275
GSK Investigational Site
Murmansk, Russian Federation, 183001
GSK Investigational Site
N.Novgorod, Russian Federation, 603005
GSK Investigational Site
Orel, Russian Federation, 302040
GSK Investigational Site
Perm, Russian Federation, 614990
GSK Investigational Site
Ryazan, Russian Federation, 390046
GSK Investigational Site
Saint-Petersburg, Russian Federation
GSK Investigational Site
Samara, Russian Federation
GSK Investigational Site
Saratov, Russian Federation, 410009
GSK Investigational Site
Smolensk, Russian Federation, 214006
GSK Investigational Site
St. Petersburg, Russian Federation, 196645
GSK Investigational Site
Volgograd, Russian Federation, 400040
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, 1000
Spain
GSK Investigational Site
Alcala de Henares, Spain, 28805
GSK Investigational Site
Alicante, Spain, 03010
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Baracaldo/Vizcaya, Spain, 48903
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 8400
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Barcelona, Spain, 08907
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Bilbao, Spain, 48013
GSK Investigational Site
Calella, Spain, 08370
GSK Investigational Site
Córdoba, Spain, 14004
GSK Investigational Site
Elche (Alicante), Spain, 03202
GSK Investigational Site
Granada, Spain, 18003
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain, 28029
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Malaga, Spain, 29010
GSK Investigational Site
Marid, Spain, 28040
GSK Investigational Site
Mataro, Spain, 08034
GSK Investigational Site
Oviedo, Spain, 33006
GSK Investigational Site
Reus, Spain, 43201
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
Santander, Spain, 39008
GSK Investigational Site
Sevilla, Spain, 41013
GSK Investigational Site
Sevilla, Spain, 41041
GSK Investigational Site
Sevilla, Spain, 41071
GSK Investigational Site
Tarragona, Spain, 43007
GSK Investigational Site
Valencia, Spain, 46010
GSK Investigational Site
Valencia, Spain, 46015
GSK Investigational Site
Vigo ( Pontevedra), Spain, 36204
GSK Investigational Site
Vitoria, Spain, 01009
Switzerland
GSK Investigational Site
Basel, Switzerland, 4031
GSK Investigational Site
Bruderholz, Switzerland, 4101
GSK Investigational Site
La Chaux-de-Fonds, Switzerland, CH 2301
GSK Investigational Site
Lausanne, Switzerland, 1011
GSK Investigational Site
Lausanne, Switzerland, 1004
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
St Gallen, Switzerland, 9007
GSK Investigational Site
Zurich, Switzerland, 8038
United Kingdom
GSK Investigational Site
Derby, Derbyshire, United Kingdom, DE1 2QY
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M8 5RB
GSK Investigational Site
Woolwich, London, London, United Kingdom, SE18 4QH
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
GSK Investigational Site
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 7PA
GSK Investigational Site
Belfast, United Kingdom, BT12 6BA
GSK Investigational Site
Birmingham, United Kingdom, WS2 9PS
GSK Investigational Site
Coventry, United Kingdom, CV1 4FH
GSK Investigational Site
Dudley, Birmingham, United Kingdom, DY1 4SE
GSK Investigational Site
East Yorkshire, United Kingdom, HU16 5JQ
GSK Investigational Site
Farnworth, Bolton, United Kingdom, BL4 0JR
GSK Investigational Site
Glasgow, United Kingdom, G12 0YN
GSK Investigational Site
Gloucester, United Kingdom, GL1 3NN
GSK Investigational Site
Leicester, United Kingdom, LE1 5WW
GSK Investigational Site
London, United Kingdom, N18 1QX
GSK Investigational Site
London, United Kingdom, SW10 9TH
GSK Investigational Site
London, United Kingdom, SE13 6LR
GSK Investigational Site
London, United Kingdom, SW17 0QT
GSK Investigational Site
London, United Kingdom, W2 1NY
GSK Investigational Site
London, United Kingdom, NW3 2QG
GSK Investigational Site
Middlesborough, United Kingdom, TS4 3BW
GSK Investigational Site
Plaistow, London, United Kingdom, E13 8SL
GSK Investigational Site
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MB BS MRCP FFPM GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00340080     History of Changes
Other Study ID Numbers: CNA106030, PREDICT-1
Study First Received: June 19, 2006
Last Updated: January 21, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Abacavir
Pharmacogenetics
hypersensitivity
HLA-B*5701

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Susceptibility
Hypersensitivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Abacavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 19, 2014