Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00435656
Status:
COMPLETED
Last Update Posted:
2011-08-25
First Post:
2007-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenetics of Antiretroviral Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'lastUpdateSubmitDate': '2011-08-24', 'studyFirstSubmitDate': '2007-02-14', 'studyFirstSubmitQcDate': '2007-02-14', 'lastUpdatePostDateStruct': {'date': '2011-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Human immunodeficiency virus'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'In this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV.', 'detailedDescription': 'The development of new active substances is a continuous source of progress in pharmacotherapy. However, the search for an optimal use of existing molecules constitutes another possible way of progress. In the particular field of anti-infectious therapy, an optimization of treatments could minimize the emergence of resistance phenomena that require the continuous development of new active molecules.\n\nPharmacogenetics is the scientific discipline seeking to improve the response to drug therapies (better clinical efficiency and reduction of side effects) by taking into consideration the genetic characteristics of the patient. Drugs with a narrow therapeutic index constitute a main target of this emerging field. The combination of therapeutic drug monitoring and pharmacogenetics already allows to optimize the use of some drugs among which oral anticoagulants, immunosuppressants, antiepileptics, antidepressors, antibiotics or antivirals….\n\nIn this research project, we will study the genetic determinants that influence the pharmacokinetics of antiretroviral drugs used in the treatment of diseases caused by the HIV. We will put a particular emphasis on viral protease inhibitors (atazanavir, saquinavir, lopinavir, ritonavir)and non-nucleosides reverse transcriptase inhibitors (nevirapine and efavirenz). For those drugs, the clinician often faces a double therapeutic risk, either of insufficient dosing (clinical inefficacy and emergence of resistance) or of excessive dosing (toxicity). The optimization of drug dosing is especially crucial because some of these drugs often represent the last choice in multi-resistant patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HIV infected patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infected patients\n\nExclusion Criteria:\n\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT00435656', 'briefTitle': 'Pharmacogenetics of Antiretroviral Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'orgStudyIdInfo': {'id': '2006/11OCT/AC/189'}}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Vincent Haufroid, PharmD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- 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': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Laure Elens', 'investigatorAffiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}}}}