Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT00159068
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Genetic Factors Which May Influence the Course of HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA isolated from peripheral blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '15080180', 'type': 'BACKGROUND', 'citation': 'Tang J, Kaslow RA. The impact of host genetics on HIV infection and disease progression in the era of highly active antiretroviral therapy. AIDS. 2003;17 Suppl 4:S51-60. doi: 10.1097/00002030-200317004-00006. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Patients with HIV an have a variable course of their infection. We are trying to identify factors which worsen or ameliorate the course of the disease. Such factors may be related to metabolism (breakdown) of drugs or to iron handling by the body.', 'detailedDescription': 'Patients with HIV can have a variable course and the disease may be influenced by polymorphisms in drug metabolism and disposition genes such as MDR1 and CYP3A4. In addition, reports have linked changes in the course of the disease with iron status, with high iron being detrimental. We will study polymorphisms in these genes and correlate with clinical course in HIV patients and also with phenotype of drug resistance and disease parameters (such as CD4 counts and opportunistic infections).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HIV attending the HIV clinic at Hadassah colden globes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of HIV\n\nExclusion Criteria:\n\n* under 18 years of age'}, 'identificationModule': {'nctId': 'NCT00159068', 'briefTitle': 'Analysis of Genetic Factors Which May Influence the Course of HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Genetic Influences on the Course and Response to Treatment of HIV: Contribution of Polymorphisms in Drug Metabolism and Disposition Genes and Haptoglobin Polymorphisms', 'orgStudyIdInfo': {'id': '391200-HMO-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': 'IL91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Deborah Rund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deborah Rund', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Hematologist', 'investigatorFullName': 'Deborah Rund', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}