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

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

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 Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Abacavir

• Study Type: Interventional
• Enrollment: 1806
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • GSK Investigational Site
  • Queensland
    • Miami, Queensland, Australia, 4220
      • GSK Investigational Site
• Austria
  • 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
    • GSK Investigational Site
• Belgium
  • 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
    • GSK Investigational Site
• France
  • 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, 13005
    • GSK Investigational Site
  • Marseille, France, 13274
    • GSK Investigational Site
  • Marseille, France, 13915
    • GSK Investigational Site
  • Marseille, France, 13006
    • 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, 75018
    • GSK Investigational Site
  • Paris, France, 75014
    • 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
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 13353
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20146
    • GSK Investigational Site
  • Hamburg, Germany, 20095
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79098
      • GSK Investigational Site
    • Stuttgart, Baden-Wuerttemberg, Germany, 70197
      • GSK Investigational Site
  • Bayern
    • 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
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
      • GSK Investigational Site
    • Hannover, Niedersachsen, Germany, 30625
      • GSK Investigational Site
    • Osnabrueck, Niedersachsen, Germany, 49090
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • 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, 48143
      • GSK Investigational Site
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55116
      • GSK Investigational Site
  • Sachsen
    • Leipzig, Sachsen, Germany, 04170
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • GSK Investigational Site
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24116
      • GSK Investigational Site
• Ireland
  • Dublin, Ireland, 8
    • GSK Investigational Site
• Israel
  • Kfar Saba, Israel, 44281
    • GSK Investigational Site
  • Ramat Gan, Israel, 52621
    • GSK Investigational Site
  • Rehovot, Israel, 76100
    • GSK Investigational Site
  • Tel-Aviv, Israel, 64239
    • GSK Investigational Site
• Italy
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • GSK Investigational Site
  • Campania
    • Napoli, Campania, Italy, 80131
      • GSK Investigational Site
    • Salerno, Campania, Italy, 84131
      • GSK Investigational Site
  • Emilia-Romagna
    • 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
      • GSK Investigational Site
  • Lazio
    • Latina, Lazio, Italy, 04100
      • GSK Investigational Site
    • Roma, Lazio, Italy, 00161
      • GSK Investigational Site
    • Roma, Lazio, Italy, 00185
      • GSK Investigational Site
  • Liguria
    • Genova, Liguria, Italy, 16132
      • GSK Investigational Site
    • Sanremo (im), Liguria, Italy, 18032
      • GSK Investigational Site
  • Lombardia
    • 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, 20157
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20142
      • GSK Investigational Site
  • Marche
    • Torrette Di Ancona (an), Marche, Italy, 60020
      • GSK Investigational Site
  • Piemonte
    • Asti, Piemonte, Italy, 14100
      • GSK Investigational Site
    • Pallanza (Verbania), Piemonte, Italy, 28921
      • GSK Investigational Site
    • Torino, Piemonte, Italy, 10149
      • GSK Investigational Site
  • Puglia
    • Bari, Puglia, Italy, 70124
      • GSK Investigational Site
  • Sardegna
    • Cagliari, Sardegna, Italy, 09121
      • GSK Investigational Site
    • Sassari, Sardegna, Italy, 71000
      • GSK Investigational Site
  • Sicilia
    • Catania, Sicilia, Italy, 95100
      • GSK Investigational Site
  • Toscana
    • Grosseto, Toscana, Italy, 58100
      • GSK Investigational Site
  • Trentino-Alto Adige
    • Bolzano, Trentino-Alto Adige, Italy, 39100
      • GSK Investigational Site
  • Veneto
    • Padova, Veneto, Italy, 35128
      • GSK Investigational Site
    • Treviso, Veneto, Italy, 31100
      • GSK Investigational Site
    • Vicenza, Veneto, Italy, 36100
      • GSK Investigational Site
• Latvia
  • Riga, Latvia, LV1006
    • GSK Investigational Site
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • GSK Investigational Site
  • Amsterdam, Netherlands, 1091 AC
    • GSK Investigational Site
  • Arnhem, Netherlands, 6815 AD
    • GSK Investigational Site
  • Den Haag, Netherlands, 2545 CH
    • GSK Investigational Site
  • Den Haag, Netherlands, 2512 VA
    • 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, 3015 GD
    • GSK Investigational Site
  • Rotterdam, Netherlands, 3078 HT
    • GSK Investigational Site
  • Tilburg, Netherlands, 5022 GC
    • GSK Investigational Site
  • Vlissingen, Netherlands, 4382 EE
    • GSK Investigational Site
  • Zwolle, Netherlands, 8025 AB
    • GSK Investigational Site
• Norway
  • Fredrikstad, Norway, 1606
    • GSK Investigational Site
  • Oslo, Norway, 0450
    • GSK Investigational Site
• Poland
  • 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
    • GSK Investigational Site
• Portugal
  • 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
    • GSK Investigational Site
• Romania
  • Bucharest, Romania, 021105
    • GSK Investigational Site
  • Constanta, Romania, 900709
    • GSK Investigational Site
  • Iasi, Romania, 700116
    • GSK Investigational Site
• Russian Federation
  • 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
    • GSK Investigational Site
• Slovenia
  • Ljubljana, Slovenia, 1000
    • GSK Investigational Site
• Spain
  • 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, 08035
    • GSK Investigational Site
  • Barcelona, Spain, 08003
    • GSK Investigational Site
  • Barcelona, Spain, 08907
    • GSK Investigational Site
  • Barcelona, Spain, 8400
    • 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, 28007
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Madrid, Spain
    • GSK Investigational Site
  • Madrid, Spain, 28029
    • 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, 46015
    • GSK Investigational Site
  • Valencia, Spain, 46010
    • GSK Investigational Site
  • Vigo ( Pontevedra), Spain, 36204
    • GSK Investigational Site
  • Vitoria, Spain, 01009
    • GSK Investigational Site
• Switzerland
  • 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
    • GSK Investigational Site
• United Kingdom
  • 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, SW10 9TH
    • GSK Investigational Site
  • London, United Kingdom, NW3 2QG
    • GSK Investigational Site
  • London, United Kingdom, SW17 0QT
    • GSK Investigational Site
  • London, United Kingdom, W2 1NY
    • GSK Investigational Site
  • London, United Kingdom, SE13 6LR
    • GSK Investigational Site
  • London, United Kingdom, N18 1QX
    • 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
    • GSK Investigational Site
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE1 2QY
      • GSK Investigational Site
  • Lancashire
    • Manchester, Lancashire, United Kingdom, M8 5RB
      • GSK Investigational Site
  • London
    • Woolwich, London, London, United Kingdom, SE18 4QH
      • GSK Investigational Site
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • GSK Investigational Site
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 7PA
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, MB BS MRCP FFPM, GlaxoSmithKline

Publications and helpful links

General Publications

• Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomazic J, Jagel-Guedes E, Rugina S, Kozyrev O, Cid JF, Hay P, Nolan D, Hughes S, Hughes A, Ryan S, Fitch N, Thorborn D, Benbow A; PREDICT-1 Study Team. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008 Feb 7;358(6):568-79. doi: 10.1056/NEJMoa0706135.

Study record dates

Study Major Dates

• Study Start: April 1, 2006

Study Registration Dates

• First Submitted: June 19, 2006
• First Submitted That Met QC Criteria: June 19, 2006
• First Posted (Estimate): June 21, 2006

Study Record Updates

• Last Update Posted (Estimate): January 25, 2010
• Last Update Submitted That Met QC Criteria: January 21, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: hypersensitivity; Pharmacogenetics; Abacavir; HLA-B*5701
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Abacavir
• Other Study ID Numbers: CNA106030; PREDICT-1