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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
"}},"ctGov":{"childMarkdownRemark":{"html":"This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.
"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"NCT00340080","ctis_id":"","HasResults":"true","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"http://","IsFlexibleTrial":false,"IsReleasedToCtGov":"true","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":"true"},"PatientLevelData":"true","SharingIpd":"None","acronym":"","allocation":"Randomized","arm_groups":[],"assignment":"Parallel Assignment","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.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Clinical Utility Of Genetic Screening For HLA-B*5701, On Susceptibility To Abacavir Hypersensitivity","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"08/01/2019 14:30:13","criteria":"Inclusion criteria: \n\n - Infected with documented HIV-1.\n\n - Subjects are Abacavir-naive (subjects can be antiretroviral therapy (ART)-naive or experienced).\n\n - 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.\n\n - If subjects are therapy naive they must meet the criteria for commencing HAART according to local guidelines.\n\n - 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:\na. 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. \nb. 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):\n - 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.\n - 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.\n - Any intrauterine device with published data showing that the expected failure rate is <1% per year.\n - Sterilisation (male partner of female subject).\n\nExclusion criteria:\n\n - Has previously received ABC-containing therapy.\n\n - 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.\n\n - The subject or any of their healthcare providers is aware of the subjects HLA type.\n\n - Has undergone an allogeneic bone marrow transplant.\n\n - 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.\n\n - 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. \n\n - Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject’s participation in the study. \n\n - Pregnant women or women who are breastfeeding. \n\n - Any immunisation within 30 days prior to Day 1.\n\n - Subject is, in the opinion of the Investigator, unable to complete the 6 week Observation period and the EPT assessments as required.\n\n - 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. \n\n - Subject is enrolled in one or more investigational drug/vaccine protocols.\n\n - In France, an eligible subject is neither affiliated with nor a beneficiary of a social security category. \n\n - A subject will not be eligible for progression to Baseline (Day 1) if any of the following criteria apply:\n - A positive result for HLA-B*5701 in those subjects randomised to the genetic screening arm.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Completed","display_status_internal":"RECSTATUS_I_COMPLETED","endpoint":"","enrollment":"1806","exclusion":"","gender":"All","gender_based":"","gender_description":"","healthy_volunteers":"No","id":"5d005136-828b-5d31-a855-a12c6646a036","internal":{"content":null,"contentDigest":"f51464a61fa15139724d6000255ca1bc","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion criteria: \n\n - Infected with documented HIV-1.\n\n - Subjects are Abacavir-naive (subjects can be antiretroviral therapy (ART)-naive or experienced).\n\n - 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.\n\n - If subjects are therapy naive they must meet the criteria for commencing HAART according to local guidelines.\n\n - 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:\na. 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. \nb. 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):\n - 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.\n - 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.\n - Any intrauterine device with published data showing that the expected failure rate is <1% per year.\n - Sterilisation (male partner of female subject).\n\nExclusion criteria:\n\n - Has previously received ABC-containing therapy.\n\n - 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.\n\n - The subject or any of their healthcare providers is aware of the subjects HLA type.\n\n - Has undergone an allogeneic bone marrow transplant.\n\n - 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.\n\n - 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. \n\n - Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject’s participation in the study. \n\n - Pregnant women or women who are breastfeeding. \n\n - Any immunisation within 30 days prior to Day 1.\n\n - Subject is, in the opinion of the Investigator, unable to complete the 6 week Observation period and the EPT assessments as required.\n\n - 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. \n\n - Subject is enrolled in one or more investigational drug/vaccine protocols.\n\n - In France, an eligible subject is neither affiliated with nor a beneficiary of a social security category. \n\n - A subject will not be eligible for progression to Baseline (Day 1) if any of the following criteria apply:\n - A positive result for HLA-B*5701 in those subjects randomised to the genetic screening arm.","interventions":[{"arm_group_label":"","intervention_description":"","intervention_name":"Abacavir","intervention_type":"Drug"}],"interventional_subtype":"Treatment","is_fda_regulated":null,"is_high_value":false,"is_ind_study":false,"keywords":["Pharmacogenetics","HLA-B*5701","Abacavir","hypersensitivity"],"last_follow_up_date":"02/13/2007 00:00:00","links":[{"description":"","url":"https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&parentIdentifier=CNA106030&attachmentIdentifier=a227e8df-3916-41a5-994c-ae765fb49f9c&fileName=20594.pdf&versionIdentifier="}],"locations":[{"City":"Darlinghurst","Latitude":"-33.8780176","CountryDisplay":"Australia","Longitude":"151.2204441","Name":"GSK Investigational Site","StateDisplay":"New South Wales","PostalCode":"2010","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Ljubljana","Latitude":"46.0569465","CountryDisplay":"Slovenia","Longitude":"14.5057515","Name":"GSK Investigational Site","StateDisplay":null,"PostalCode":"1000","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"},{"City":"Miami","Latitude":"-28.067222","CountryDisplay":"Australia","Longitude":"153.436944","Name":"GSK Investigational Site","StateDisplay":"Queensland","PostalCode":"4220","StatusDisplay":"Completed","StatusDisplayInternal":"LOCSTATUS_COMPLETED","StatusMapped":"Study Complete"}],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 years","modified_date":"06/18/2024 13:30:37","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"","number_of_groups":"","observational_study_design":"","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":""},"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","org_study_id":"CNA106030","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 4","primary_compl_date":"02/13/2007 00:00:00","primary_outcomes":[{"outcome_description":"The clinical syndrome of ABC HSR was characterized by an onset within the first 6 Weeks of ABC treatment, typically presenting with constitutional symptoms (fever, malaise, lethargy), with frequent involvement of the skin (rash) and/or gastrointestinal tract (nausea, vomiting, abdominal pain and diarrhoea). The wide array of clinical symptoms that signifies ABC HSR (e.g., respiratory or musculoskeletal symptoms, headache, paraesthesia, oedema, renal or hepatic failure or anaphylaxis) leads to uncertainty in the diagnostic classification of ABC HSR. All participants who reported clinical symptoms that signified ABC HSR during the observation period were categorized under CS ABC HSR. One participant was excluded from the model due to missing Race value.","outcome_measure":"Number of participants of clinically-suspected (CS) Abacavir Hypersensitivity Reaction (ABC HSR) during the 6 Week observation period.","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The clinical syndrome of ABC HSR was characterized by an onset within the first 6 Weeks of ABC treatment, typically presenting with constitutional symptoms (fever, malaise, lethargy), with frequent involvement of the skin (rash) and/or gastrointestinal tract (nausea, vomiting, abdominal pain and diarrhoea). The wide array of clinical symptoms that signifies ABC HSR (e.g., respiratory or musculoskeletal symptoms, headache, paraesthesia, oedema, renal or hepatic failure or anaphylaxis) leads to uncertainty in the diagnostic classification of ABC HSR. The clinically-suspected ABC HSR participants underwent Epicutaneous Patch Test (EPT) assessments atleast 6 Weeks after clinical diagnosis of the HSR, the results of which were reviewed by an independent clinical evaluation committee (ICEC). The interpretation of the EPT results provided by the ICEC formed the IC ABC HSR.","outcome_measure":"Number of participants with immunologically-confirmed (IC) (clinical diagnosis plus epicutaneous patch testing) ABC HSR; the clinical diagnosis of which occurs over the 6 Week observation period. One participant was excluded due to missing race.","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null}],"product_name":"abacavir","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"The clinical syndrome of ABC HSR was characterized by an onset within the first 6 Weeks of ABC treatment, typically presenting with constitutional symptoms (fever, malaise, lethargy), with frequent involvement of the skin (rash) and/or gastrointestinal tract (nausea, vomiting, abdominal pain and diarrhoea). The wide array of clinical symptoms that signifies ABC HSR (e.g., respiratory or musculoskeletal symptoms, headache, paraesthesia, oedema, renal or hepatic failure or anaphylaxis) leads to uncertainty in the diagnostic classification of ABC HSR. All participants who reported clinical symptoms that signified ABC HSR during the observation period were categorized under CS ABC HSR.","outcome_measure":"Number of participants of CS ABC HSR in Caucasians during the 6 Week observation period.","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The clinical syndrome of ABC HSR was characterized by an onset within the first 6 Weeks of ABC treatment, typically presenting with constitutional symptoms (fever, malaise, lethargy), with frequent involvement of the skin (rash) and/or gastrointestinal tract (nausea, vomiting, abdominal pain and diarrhoea). The wide array of clinical symptoms that signifies ABC HSR (e.g., respiratory or musculoskeletal symptoms, headache, paraesthesia, oedema, renal or hepatic failure or anaphylaxis) leads to uncertainty in the diagnostic classification of ABC HSR. All participants who reported clinical symptoms that signified ABC HSR during the observation period were categorized under CS ABC HSR.","outcome_measure":"Number of participants of CS ABC HSR in different ethnic sub-groups during the 6 Week observation period.","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The clinical syndrome of ABC HSR was characterized by an onset within the first 6 Weeks of ABC treatment, typically presenting with constitutional symptoms (fever, malaise, lethargy), with frequent involvement of the skin (rash) and/or gastrointestinal tract (nausea, vomiting, abdominal pain and diarrhoea). The wide array of clinical symptoms that signifies ABC HSR (e.g., respiratory or musculoskeletal symptoms, headache, paraesthesia, oedema, renal or hepatic failure or anaphylaxis) leads to uncertainty in the diagnostic classification of ABC HSR. The clinically-suspected ABC HSR participants underwent Epicutaneous Patch Test (EPT) assessments atleast 6 Weeks after clinical diagnosis of the HSR, the results of which were reviewed by an independent clinical evaluation committee (ICEC). The interpretation of the EPT results provided by the ICEC formed the IC ABC HSR. Here results for only the Caucasian population has been included.","outcome_measure":"Number of participants of IC (clinical diagnosis plus EPT) ABC HSR in Caucasians during the 6 Week observation period.","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The clinical syndrome of ABC HSR was characterized by an onset within the first 6 Weeks of ABC treatment, typically presenting with constitutional symptoms (fever, malaise, lethargy), with frequent involvement of the skin (rash) and/or gastrointestinal tract (nausea, vomiting, abdominal pain and diarrhoea). The wide array of clinical symptoms that signifies ABC HSR (e.g., respiratory or musculoskeletal symptoms, headache, paraesthesia, oedema, renal or hepatic failure or anaphylaxis) leads to uncertainty in the diagnostic classification of ABC HSR. The CS ABC HSR participants underwent Epicutaneous Patch Test (EPT) assessments atleast 6 Weeks after clinical diagnosis of the HSR, the results of which were reviewed by an independent clinical evaluation committee (ICEC). The interpretation of the EPT results provided by the ICEC formed the immunologically-confirmed ABC HSR. Here results for only the ethnic sub-groups has been included.","outcome_measure":"Number of participants of IC (clinical diagnosis plus EPT) ABC HSR in different ethnic sub-groups during the 6 Week observation period.","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The sensitivity of the genetic test for HLA-B*5701 test was estimated as the percentage of participants with an ABC HSR who had a positive genetic test. Results for participants of CS HSR has been provided here. White & African American (WAA), Asian and Native Hawaiian (ANH), White and American Indian (WAI), White and Asian and Native Hawaiian (WANH) and White and Asian and African American (WAAA).","outcome_measure":"Sensitivity of genetic screening for HLA-B*5701 for susceptibility of CS HSR, overall and by ethnic sub-group.","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The specificity of the genetic test for HLA-B*5701 was estimated as the percentage of participants without an ABC HSR who had a negative genetic test. Results for participants of CS HSR has been provided here.","outcome_measure":"Specificity of genetic screening for HLA-B*5701 for susceptibility of clinically-suspected HSR, overall and by ethnic sub-group","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The negative predictive value (NPV) of the genetic test for HLA-B*5701 was estimated as the percentage of participants with a negative genetic test who did not have an ABC HSR. Results for participants of CS HSR has been provided here.","outcome_measure":"Negative predictive value of genetic screening for HLA-B*5701 for susceptibility of CS HSR, overall and by ethnic sub-group","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The positive predictive value (PPV) of the genetic test for HLA-B*5701 was estimated as the percentage of participants with a positive genetic test who had an ABC HSR. Results for participants of CS HSR has been provided here.","outcome_measure":"Positive predictive value of genetic screening for HLA-B*5701 for susceptibility of CS HSR, overall and by ethnic sub-group","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The sensitivity of the genetic test for HLA-B*5701 test was estimated as the percentage of participants with an ABC HSR who had a positive genetic test. Results for participants of IC HSR has been provided here.","outcome_measure":"Sensitivity of genetic screening for HLA-B*5701 for susceptibility of IC HSR , overall and by ethnic sub-group","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The specificity of the genetic test for HLA-B*5701 was estimated as the percentage of participants without an ABC HSR who had a negative genetic test. Results for participants of CS HSR has been provided here.","outcome_measure":"Specificity of genetic screening for HLA-B*5701 for susceptibility of IC HSR , overall and by ethnic sub-group","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The negative predictive value (NPV) of the genetic test for HLA-B*5701 was estimated as the percentage of participants with a negative genetic test who did not have an ABC HSR. Results for participants of IC HSR has been provided here.","outcome_measure":"Negative predictive value of genetic screening for HLA-B*5701 for susceptibility of IC HSR , overall and by ethnic sub-group","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"The positive predictive value (PPV) of the genetic test for HLA-B*5701 was estimated as the percentage of participants with a positive genetic test who had an ABC HSR. Results for participants of IC HSR has been provided here.","outcome_measure":"Positive predictive value of genetic screening for HLA-B*5701 for susceptibility of IC HSR , overall and by ethnic sub-group","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"All participants, irrespective of study arm, reporting CS ABC HSR during the observation period underwent EPT assessment at 6 Weeks after clinical diagnosis of the HSR. The EPT assessment period consisted of at least three visits: a visit to apply the test patch and two subsequent visits to read the tests at 24 hours post-application and 48 hours post-application. Participants with an equivocal patch test result underwent further EPT assessment. The ICEC reviewed the digital photographs of skin patch tests and other relevant information from the Case Report Form (CRF) and EPT assessments and were blinded to the HLA status of the individual participants. Following this review, the ICEC determined whether or not EPTs are positive or negative.","outcome_measure":"Number of participants with patch test positive and patch test negative results in participants who have not developed CS ABC HSR.","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"Unscheduled outpatient visits, inpatient days in hospital and other healthcare contacts were recorded for all HIV-associated conditions and adverse events in the Unplanned Health Care Resource Utilization form. The form was completed by the Investigator based on participant self-report at Weeks 1, 2 and 6 and at the HSR visit and at withdrawal.","outcome_measure":"Summary of Mean Unscheduled Healthcare Resource Utilization Measurement","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null},{"outcome_description":"Unscheduled outpatient visits, inpatient days in hospital and other healthcare contacts were recorded for all HIV-associated conditions and adverse events in the Unplanned Health Care Resource Utilization form. The form was completed by the Investigator based on participant self-report at Weeks 1, 2 and 6 and at the HSR visit and at withdrawal.","outcome_measure":"Number of participants Using Unscheduled Healthcare Resource Measurement","outcome_time_frame":"Up to 6 Weeks","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":[]},"start_date":"04/24/2006 00:00:00","study_type":"Interventional","therapeutic_area":"Infectious Diseases","citations":[{"citation":"Hughes AR, Spreen WR, Brothers CH et al. Prospective Validation of HLA-B*5701 Screening to Reduce the Incidence of Abacavir Hypersensitivity. Presented at the Cold Spring Harbor Conference on Pharmacogenetics, Hinxton, UK. October 17-20, 2007.","is_results_ref":"Yes","pubmed_id":""},{"citation":"Hughes S, Hughes A, Brothers C, et al. PREDICT-1 (CNA106030): the first powered, prospective trial of pharmacogenetic screening to reduce drug adverse events. Pharmaceut. Statist. (published online 29 May 2007) DOI: 10.1002/pst.286.","is_results_ref":"Yes","pubmed_id":""},{"citation":"Hughes S, Parry-Billings K, Givens N, Wong D, Loeschel E, Parada P, Zamoryakhin D, Goodwin C, Hughes A, Muir J, Curtis L, Thorborn D. PREDICT-1: Description of a Novel Randomised Prospective Study Design to Determine the Clinical Utility of Prognostic Scr","is_results_ref":"Yes","pubmed_id":""},{"citation":"Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med 2008; 358: 568-79.","is_results_ref":"Yes","pubmed_id":""},{"citation":"Mallal S, Phillips E, Carosi G, Molina JM, Workman C, Tomazic J, Jagel-Guedes E, Rugina S, Kozyrev O, Flores-Cid J, Hay P, Nolan D, Hughes S, Hughes A, Thorborn D, Benbow A. PREDICT-1 LB: A double blind randomized study to evaluate the clinical utility of","is_results_ref":"Yes","pubmed_id":""},{"citation":"Molina JM, Mallal S, Phillips E, Carosi G, Workman C, Tomažic J, Jägel-Guedes E, Rugina S., Kozyrev O, Flores Cid J, Hay P, Nolan D, Hughes ., Hughes A, Thorborn D, Benbow A :PREDICT-1: Prospective HLA-B*5701 Screening Significantly Reduces The Incidence","is_results_ref":"Yes","pubmed_id":""},{"citation":"Phillips E, Staszewski S, Arribas J, Fitch N, Givens N: PREDICT-1: Characteristics of abacavir hypersensitivity diagnoses according to HLA-B*5701 status and subsequent abacavir patch test result. Poster presentation at EACS, Madrid, Spain, October 24-27,","is_results_ref":"Yes","pubmed_id":""}],"is_section_801":null}},"pageContext":{"studyId":"CNA106030"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}