Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-19 @ 4:48 PM
Study NCT ID:
NCT02514369
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2015-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenomics of New Antiretrovirals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-07-31', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of pharmacogenomics on plasma concentration of new antiretroviral drugs', 'timeFrame': 'up to 48 months', 'description': 'The geometric mean (GM) of cell associated concentration and plasmatic concentration of ARV drug'}, {'measure': 'Impact of pharmacogenomics on intracellular concentration of new antiretroviral drugs', 'timeFrame': 'up to 48 months', 'description': 'The geometric mean (GM) of cell associated concentration and plasmatic concentration of ARV drug'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '26742721', 'type': 'RESULT', 'citation': 'Belkhir L, De Laveleye M, Vandercam B, Zech F, Delongie KA, Capron A, Yombi J, Vincent A, Elens L, Haufroid V. Quantification of darunavir and etravirine in human peripheral blood mononuclear cells using high performance liquid chromatography tandem mass spectrometry (LC-MS/MS), clinical application in a cohort of 110 HIV-1 infected patients and evidence of a potential drug-drug interaction. Clin Biochem. 2016 May;49(7-8):580-6. doi: 10.1016/j.clinbiochem.2015.12.011. Epub 2015 Dec 29.'}]}, 'descriptionModule': {'briefSummary': 'Some genetic polymorphisms are known to interfere with ARV metabolism and are therefore likely to explain some of the inter-individual variations (efficacy,toxicity,resistance) observed during ART. The most common form of human DNA variations consists of a change of a base in the nucleotide sequence of an individual at a given position, the single nucleotide polymorphism (SNP). Therefore,the purpose of this research will be the identification and characterization of the clinical impact of several SNPs in gene coding for transport proteins (e.g.ABCB1,ABCC1) and biotransformation enzymes (e.g.CYP3A4,CYP2B6) known to be involved in the pharmacokinetic pathway of selected ARV drugs for which the therapeutic response is difficult to predict. Aside,the influence of these SNPs on the response to treatment (CD4+cell,viral load) and on the toxicity will be evaluated. Plasma concentrations of ARV drugs correlate with therapeutic efficacy but also with the risk of toxicity and of virological failure, which is the basis of the therapeutic drug monitoring. However,given the intracellular location of HIV, analyzing intracellular drug concentrations is fundamental and the investigators will also focus of this new topic.', 'detailedDescription': 'Some genetic polymorphisms are known to interfere with ARV metabolism and are therefore likely to explain some of the inter-individual variations (efficacy,toxicity,resistance) observed during ART. The most common form of human DNA variations consists of a change of a base in the nucleotide sequence of an individual at a given position, the single nucleotide polymorphism (SNP). Therefore,the purpose of this research will be the identification and characterization of the clinical impact of several SNPs in gene coding for transport proteins (e.g.ABCB1,ABCC1) and biotransformation enzymes (e.g.CYP3A4,CYP2B6) known to be involved in the pharmacokinetic pathway of selected ARV drugs for which the therapeutic response is difficult to predict. Considering that CYP3A5 may represent up to 50% of the total hepatic CYP3A content in CYP3A5\\*1 allele carriers, the CYP3A5 genetic polymorphism may be therefore the most important genetic contributor not only to interindividual but also to interracial differences in CYP3A-dependent drug clearance.\n\nAside,the influence of these SNPs on the response to treatment (CD4+cell,viral load) and on the toxicity will be evaluated.\n\nPlasma concentrations of ARV drugs correlate with therapeutic efficacy but also with the risk of toxicity and of virological failure, which is the basis of the therapeutic drug monitoring. However,given the intracellular location of HIV, analyzing intracellular drug concentrations is fundamental and the investigators will also focus of this new topic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HIV1-positive patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 positive treated with drug of interest\n\nExclusion Criteria:\n\n* \\<18 years old'}, 'identificationModule': {'nctId': 'NCT02514369', 'briefTitle': 'Pharmacogenomics of New Antiretrovirals', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Pharmacogenetics of New Antiretroviral Drugs', 'orgStudyIdInfo': {'id': 'ARVLB01'}}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Leila Belkhir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Catholique de Louvain', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}