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

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Abacavir
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring Abacavir, Pharmacogenetics, hypersensitivity, HLA-B*5701

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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). 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.

Sites / Locations

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Outcomes

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.

Full Information

First Posted
June 19, 2006
Last Updated
January 21, 2010
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00340080
Brief Title
Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
Abacavir, Pharmacogenetics, hypersensitivity, HLA-B*5701

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1806 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
18256392
Citation
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.
Results Reference
derived

Learn more about this trial

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

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