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

NCT00340080 | Completed Phase 4

• 2 other identifiers: CNA106030PREDICT-1
• Study Type: interventional
• Target: 1,806
• Locations: 18 countries
• Sites: 252

Brief Summary

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 Subjects who experience suspected ABC HSR during the 6-week observation will be withdrawn from ABC-containing product and undergo EPT patch testing 6 weeks later.

Conditions

HIV Infection

Keywords

Abacavir; Pharmacogenetics; hypersensitivity; HLA-B*5701

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Abacavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (254)

GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

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GSK Investigational Site

Miami, Queensland, 4220, Australia

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GSK Investigational Site

Graz, A-8020, Austria

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Innsbruck, A-6020, Austria

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Linz, A-4020, Austria

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GSK Investigational Site

Salzburg, A-5020, Austria

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GSK Investigational Site

Vienna, A-1090, Austria

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GSK Investigational Site

Bruges, 8000, Belgium

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GSK Investigational Site

Brussels, 1000, Belgium

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GSK Investigational Site

Brussels, 1050, Belgium

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GSK Investigational Site

Brussels, 1070, Belgium

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GSK Investigational Site

Brussels, 1090, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Liège, 4000, Belgium

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GSK Investigational Site

Aix-en-Provence, 13616, France

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GSK Investigational Site

Amiens, 80054, France

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GSK Investigational Site

Angers, 49000, France

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GSK Investigational Site

Annecy, 74011, France

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GSK Investigational Site

Avignon, 84000, France

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GSK Investigational Site

Besançon, 25030, France

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Bobigny, 93009, France

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Bondy, 93143, France

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GSK Investigational Site

Bordeaux, 33000, France

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Bordeaux, 33076, France

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Caen, 14000, France

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GSK Investigational Site

Cannes, 06401, France

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GSK Investigational Site

Clermont-Ferrand, 63058, France

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GSK Investigational Site

Corbeil-Essonnes, 91106, France

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Créteil, 94010, France

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Dijon, 21079, France

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GSK Investigational Site

Fréjus, 83608, France

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GSK Investigational Site

Grenoble, 38043, France

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GSK Investigational Site

La Roche-sur-Yon, 85025, France

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La Rochelle, 17019, France

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GSK Investigational Site

Le Kremlin-Bicêtre, 94275, France

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GSK Investigational Site

Levallois-Perret, 92300, France

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Lyon, 69437, France

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Marseille, 13005, France

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Marseille, 13006, France

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Marseille, 13274, France

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Marseille, 13285, France

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Marseille, 13915, France

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Metz, 57000, France

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Montpellier, 34295, France

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GSK Investigational Site

Mulhouse, 68000, France

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Nantes, 44093, France

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GSK Investigational Site

Nice, 06202, France

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GSK Investigational Site

Niort, 79021, France

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GSK Investigational Site

Nîmes, 30029, France

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Orléans, 45100, France

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GSK Investigational Site

Paris, 75014, France

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GSK Investigational Site

Paris, 75018, France

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GSK Investigational Site

Paris, 75475, France

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GSK Investigational Site

Paris, 75651, France

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GSK Investigational Site

Paris, 75679, France

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GSK Investigational Site

Paris, 75970, France

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Perpignan, 66046, France

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GSK Investigational Site

Poitiers, 86021, France

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GSK Investigational Site

Quimper, 29107, France

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Reims, 51092, France

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GSK Investigational Site

Rennes, 35033, France

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GSK Investigational Site

Rouen, 76030, France

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GSK Investigational Site

Saint-Brieuc, 22023, France

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GSK Investigational Site

Saint-Denis, 93205, France

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Saint-Etienne, 42055, France

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Saint-Germain-en-Laye, 78100, France

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Strasbourg, 67000, France

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Toulouse, 31059, France

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GSK Investigational Site

Tourcoing, 59208, France

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GSK Investigational Site

Tours, 37044, France

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GSK Investigational Site

Troyes, 10003, France

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GSK Investigational Site

Valence, 26953, France

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Valenciennes, 59300, France

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Villejuif, 94804, France

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GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany

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Stuttgart, Baden-Wurttemberg, 70197, Germany

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Erlangen, Bavaria, 91054, Germany

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Fürth, Bavaria, 90762, Germany

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GSK Investigational Site

Munich, Bavaria, 80331, Germany

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GSK Investigational Site

Munich, Bavaria, 80335, Germany

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GSK Investigational Site

Munich, Bavaria, 80801, Germany

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Würzburg, Bavaria, 97080, Germany

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Hamburg, Hamburg, 20146, Germany

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GSK Investigational Site

Hamburg, Hamburg, 20246, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

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Hanover, Lower Saxony, 30159, Germany

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Hanover, Lower Saxony, 30625, Germany

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Osnabrück, Lower Saxony, 49090, Germany

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Bochum, North Rhine-Westphalia, 44791, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Dortmund, North Rhine-Westphalia, 44137, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Münster, North Rhine-Westphalia, 48143, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Mainz, Rhineland-Palatinate, 55116, Germany

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Leipzig, Saxony, 04170, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Kiel, Schleswig-Holstein, 24116, Germany

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Berlin, State of Berlin, 13353, Germany

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Hamburg, 20095, Germany

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GSK Investigational Site

Dublin, 8, Ireland

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Kfar Saba, 44281, Israel

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Ramat Gan, 52621, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 64239, Israel

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Bari, Apulia, 70124, Italy

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Catanzaro, Calabria, 88100, Italy

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Napoli, Campania, 80131, Italy

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Salerno, Campania, 84131, Italy

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Bologna, Emilia-Romagna, 40133, Italy

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Bologna, Emilia-Romagna, 40138, Italy

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Ferrara, Emilia-Romagna, 44100, Italy

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Piacenza, Emilia-Romagna, 29100, Italy

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Rimini, Emilia-Romagna, 47900, Italy

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Latina, Lazio, 04100, Italy

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GSK Investigational Site

Rome, Lazio, 00161, Italy

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GSK Investigational Site

Rome, Lazio, 00185, Italy

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GSK Investigational Site

Genoa, Liguria, 16132, Italy

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Sanremo (im), Liguria, 18032, Italy

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Bergamo, Lombardy, 24128, Italy

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Brescia, Lombardy, 25125, Italy

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Busto Arsizio (va), Lombardy, 21052, Italy

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Cuggiono (mi), Lombardy, 20012, Italy

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GSK Investigational Site

Milan, Lombardy, 20127, Italy

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GSK Investigational Site

Milan, Lombardy, 20142, Italy

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GSK Investigational Site

Milan, Lombardy, 20157, Italy

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GSK Investigational Site

Asti, Piedmont, 14100, Italy

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GSK Investigational Site

Pallanza (Verbania), Piedmont, 28921, Italy

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GSK Investigational Site

Turin, Piedmont, 10149, Italy

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GSK Investigational Site

Cagliari, Sardinia, 09121, Italy

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GSK Investigational Site

Sassari, Sardinia, 71000, Italy

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Catania, Sicily, 95100, Italy

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GSK Investigational Site

Torrette Di Ancona (an), The Marches, 60020, Italy

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Bolzano, Trentino-Alto Adige, 39100, Italy

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Grosseto, Tuscany, 58100, Italy

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Padua, Veneto, 35128, Italy

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GSK Investigational Site

Treviso, Veneto, 31100, Italy

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Vicenza, Veneto, 36100, Italy

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GSK Investigational Site

Riga, LV1006, Latvia

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GSK Investigational Site

Alkmaar, 1815 JD, Netherlands

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GSK Investigational Site

Amsterdam, 1091 AC, Netherlands

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GSK Investigational Site

Arnhem, 6815 AD, Netherlands

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GSK Investigational Site

Enschede, 7511JX, Netherlands

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GSK Investigational Site

Flushing, 4382 EE, Netherlands

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GSK Investigational Site

Groningen, 9713 GZ, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Rotterdam, 3015 GD, Netherlands

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Rotterdam, 3078 HT, Netherlands

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The Hague, 2512 VA, Netherlands

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GSK Investigational Site

The Hague, 2545 CH, Netherlands

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Tilburg, 5022 GC, Netherlands

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GSK Investigational Site

Zwolle, 8025 AB, Netherlands

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GSK Investigational Site

Fredrikstad, 1606, Norway

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Oslo, 0450, Norway

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Bydgoszcz, 85-030, Poland

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Chorzów, 41-500, Poland

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Szczecin, 71-455, Poland

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GSK Investigational Site

Warsaw, 01-201, Poland

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GSK Investigational Site

Almada, 2805 - 267, Portugal

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Amadora, 2720-276, Portugal

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Aveiro, 4814-501, Portugal

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GSK Investigational Site

Cascais, 2750, Portugal

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Lisbon, 1150-242, Portugal

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Monte Funchal, 9054-535, Portugal

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Ponta Delgada, 9500-270, Portugal

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Porto, 4369-004, Portugal

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GSK Investigational Site

Bucharest, 021105, Romania

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GSK Investigational Site

Constanța, 900709, Romania

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Iași, 700116, Romania

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GSK Investigational Site

Barnaul, 656010, Russia

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Belgorod, 308036, Russia

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Krasnodar, 350015, Russia

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Lipetsk, 398043, Russia

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Moscow, 105275, Russia

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Murmansk, 183001, Russia

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N.Novgorod, 603005, Russia

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Oryol, 302040, Russia

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Perm, 614990, Russia

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Ryazan, 390046, Russia

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Saint Petersburg, 196645, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Saratov, 410009, Russia

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Smolensk, 214006, Russia

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Volgograd, 400040, Russia

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GSK Investigational Site

Ljubljana, 1000, Slovenia

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GSK Investigational Site

A Coruña, 15006, Spain

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Alcalá de Henares, 28805, Spain

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Alicante, 03010, Spain

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Badalona, 08916, Spain

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Baracaldo/Vizcaya, 48903, Spain

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Barcelona, 08003, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Barcelona, 08907, Spain

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Barcelona, 8400, Spain

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Bilbao, 48013, Spain

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Calella, 08370, Spain

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Córdoba, 14004, Spain

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Elche (Alicante), 03202, Spain

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Granada, 18003, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28029, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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Madrid, Spain

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GSK Investigational Site

Marid, 28040, Spain

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Mataró, 08034, Spain

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Málaga, 29010, Spain

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Oviedo, 33006, Spain

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Reus, 43201, Spain

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San Sebastián, 20014, Spain

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Santander, 39008, Spain

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Seville, 41013, Spain

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Seville, 41041, Spain

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Seville, 41071, Spain

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Tarragona, 43007, Spain

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Valencia, 46010, Spain

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Valencia, 46015, Spain

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Vigo ( Pontevedra), 36204, Spain

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Vitoria-Gasteiz, 01009, Spain

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Basel, 4031, Switzerland

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Bruderholz, 4101, Switzerland

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La Chaux-de-Fonds, CH 2301, Switzerland

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Lausanne, 1004, Switzerland

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Lausanne, 1011, Switzerland

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Lugano, 6900, Switzerland

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Sankt Gallen, 9007, Switzerland

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Zurich, 8038, Switzerland

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Derby, Derbyshire, DE1 2QY, United Kingdom

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Manchester, Lancashire, M8 5RB, United Kingdom

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Woolwich, London, London, SE18 4QH, United Kingdom

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Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

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Stoke-on-Trent, Staffordshire, ST4 7PA, United Kingdom

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Belfast, BT12 6BA, United Kingdom

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Birmingham, WS2 9PS, United Kingdom

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Coventry, CV1 4FH, United Kingdom

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Dudley, Birmingham, DY1 4SE, United Kingdom

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East Yorkshire, HU16 5JQ, United Kingdom

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Farnworth, Bolton, BL4 0JR, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Gloucester, GL1 3NN, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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London, N18 1QX, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE13 6LR, United Kingdom

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London, SW10 9TH, United Kingdom

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London, SW17 0QT, United Kingdom

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London, W2 1NY, United Kingdom

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Middlesbrough, TS4 3BW, United Kingdom

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Plaistow, London, E13 8SL, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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Related Publications (1)

• 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.

  PMID: 18256392 DERIVED

MeSH Terms

Conditions

HIV Infections; Hypersensitivity

Interventions

abacavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials, MB BS MRCP FFPM

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: April 1, 2006
• Last Updated: January 25, 2010

Record last verified: 2010-01

Locations

IL (4); AU (5); FR (60); ES (36); BE (8); NL (13); PL (4); DE (26); IT (33); NO (2); SL (1); IE (1); RO (3); CH (8); GB (23); PT (8); LA (1); RU (16)