Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00377169
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2006-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collection of Blood Samples From SMART Study Participants for Future Genetic Studies
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': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3261}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-31', 'studyFirstSubmitDate': '2006-09-14', 'studyFirstSubmitQcDate': '2006-09-14', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/show/NCT00027352', 'label': 'Click here for more information on CPCRA 065'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.', 'detailedDescription': "Despite progress in the treatment of HIV and a greater understanding of the pathophysiology of HIV infection, there are still unexplained differences in both the progression of untreated HIV infection and response to antiretroviral therapy. These differences are likely related to the unique genetic makeup of individuals with HIV infection. Particular genes may offer protection against HIV infection, while other genes may make disease progression more likely. Knowing more about the genetic makeup of HIV infected individuals may lead to the development of a targeted treatment strategy based on an individual's specific risk of disease progression and sensitivity to medication toxicity. The purpose of this substudy is to collect blood samples from SMART study participants. The samples will be used in future Community Programs for Clinical Research on AIDS (CPCRA) studies investigating the link between human genetic factors and clinical outcome data.\n\nThis study will enroll individuals currently participating in the SMART study. Participants will provide one blood sample. Individual test results from future blood analyses will not be provided to a patient unless they may have profound health implications for that patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coenrollment in the SMART study\n* Parent or guardian willing to provide informed consent, if applicable'}, 'identificationModule': {'nctId': 'NCT00377169', 'briefTitle': 'Collection of Blood Samples From SMART Study Participants for Future Genetic Studies', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)', 'orgStudyIdInfo': {'id': 'CPCRA 065H'}, 'secondaryIdInfos': [{'id': 'SMART'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AltaMed Health Services Corporation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Gay & Lesbian Community Service Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Loss Angeles Healthcare System', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33311', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Care Center/North Broward Hospital', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33602', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Hillsborough County Health Department', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Absolute Care Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AID Atlanta/Morehouse Medical School Ryan White Cl', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'AIDS Research Consortium of Atlanta (ARCA) Central', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dr. Dennis Melton (private practice)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dr. Melanie Thompson and Dr. Annette Bernard (private practice)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Dr. Richard Hudson (private practice)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic/CORNET', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'Westchester Medical Center/New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'University of North Texas Health Science Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert and Medical College I.D. Clinic', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '4101', 'city': 'Highgate Hill', 'country': 'American Samoa', 'facility': 'Gladstone Road Medical Centre'}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Perth', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Westmead', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'C.H.U. St. Pierre Center Hospitalier Universitaire', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'H2L49P', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Clinique Medicale L'actuel", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Fundacion Arriaran Santa Elvira', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': 'DK-8200', 'city': 'Brendstrupgaardvej Aarhus', 'country': 'Denmark', 'facility': 'Arbus Universitetshospital, Skejby Department of Infectious Diseases'}, {'zip': '00029 FI', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital Koln (Cologne)', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'J.W. Goethe University Hospital', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'ifi Institut', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Infektionsambulanz und Tagesklinik Poliklinik Innenstadt der', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '162-8655', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'AIDS Medical Center, International Medical Center', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '20100 MA', 'city': 'Casablanca', 'country': 'Morocco', 'facility': 'University Hospital Center Ibn Rochd', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}, {'city': 'Newtown', 'state': 'Wellington Region', 'country': 'New Zealand', 'facility': 'Wellington Hospital', 'geoPoint': {'lat': -41.31115, 'lon': 174.77935}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'city': 'Koszarawa', 'country': 'Poland', 'facility': 'Wroclaw University School of Medicine', 'geoPoint': {'lat': 49.64462, 'lon': 19.40083}}, {'zip': '2750-406 PT', 'city': 'Cascais', 'country': 'Portugal', 'facility': 'Centro Hospital de Cascais', 'geoPoint': {'lat': 38.69681, 'lon': -9.42147}}, {'zip': '1649-028 PT', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4369-004 PT', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital Joaquim Urbano', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '53105', 'city': 'Bonn', 'country': 'The Gambia', 'facility': 'Medizinische Universitatsklinik'}, {'zip': 'D-69115', 'city': 'Heidelberg', 'country': 'The Gambia', 'facility': 'Klinikum der Ruprecht-Karis-Universitat (U. Hospit)'}, {'zip': '11600', 'city': 'Montevideo', 'country': 'Uruguay', 'facility': 'Catedra de Enfermedades Infecciosas', 'geoPoint': {'lat': -34.90328, 'lon': -56.18816}}], 'overallOfficials': [{'name': 'Jonathan Uy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AIDS Research Alliance Chicago (ARAC), University of Illinois at Chicago'}, {'name': 'Roberto Arduino, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas Health Science Center, Houston'}, {'name': 'Fraser Drummond, MBChB, MRCA, DA (UK)', 'role': 'STUDY_CHAIR', 'affiliation': 'National Centre in HIV Epidemiology and Clinical Research, University of New South Wales'}, {'name': 'Daniela Gey, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Copenhagen HIV Programme, Hvidovre University Hospital'}, {'name': 'Adrian Palfreeman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Peterborough and Stamford Hospitals NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Community Programs for Clinical Research on AIDS', 'class': 'NETWORK'}]}}}