Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT00187512
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era
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': 'Plasma, serum, PMBCs, saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2033-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The general theme of this core is to investigate the relationship between the virologic response to antiretroviral therapy and clinical outcome.', 'timeFrame': 'Ongoing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'Antiretroviral Agents', 'Drug Resistance, Multiple', 'Long Term Non Progression', 'Long Term Non Progressor', 'Elite Suppression', 'Elite Suppressor', 'Natural History', 'Observational'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '21200021', 'type': 'DERIVED', 'citation': 'Favre D, Stoddart CA, Emu B, Hoh R, Martin JN, Hecht FM, Deeks SG, McCune JM. HIV disease progression correlates with the generation of dysfunctional naive CD8(low) T cells. Blood. 2011 Feb 17;117(7):2189-99. doi: 10.1182/blood-2010-06-288035. Epub 2011 Jan 3.'}]}, 'descriptionModule': {'briefSummary': 'SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. SCOPE specimens will be used to examine multiple questions involving virologic, immunologic, and host factors involved in HIV-1 infection, progression, non-progression, response to treatment, control of HIV-1 virus, and evolution of drug resistance.', 'detailedDescription': 'SCOPE is an observational, prospective study of HIV-1 infected volunteers designed to provide a specimen bank of samples with carefully characterized clinical data. Samples from SCOPE will be used to examine:\n\n1. Virologic, immunologic, and host factors involved in the natural control of HIV-1 infection (long term non-progression and/or virologic control of HIV-1 without antiretroviral therapy)\n2. Virologic and immune correlates associated with disease progression\n3. Evolution of antiretroviral drug resistance\n4. Factors associated with transmission or acquisition of HIV infection\n\nEnrolled subjects are seen at San Francisco General Hospital every four months for a detailed interview, saliva collection, and blood draw. Baseline visits take approximately one hour, follow up visits take approximately 20-40 minutes. No personal identifiers are used for specimen bank samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study is open to eligible subjects who are able to perform study visits at San Francisco General Hospital or the San Francisco VA Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSCOPE is currently recruiting HIV-1 infected subjects with any of the following criteria:\n\n1. Documented HIV viral load less than 2000 copies/ml WITHOUT taking antiretroviral therapy\n2. Undetectable HIV viral load with CD4 T-cells consistently less than 350 for the last 12 months while taking a stable antiretroviral regimen.\n3. Antiretroviral naive and planning to start an antiretroviral regimen - any CD4 or HIV viral load acceptable.\n4. Long-term Non Progressors: HIV-positive at least 10 years, no antiretroviral therapy for the past 10 years or more, any viral load acceptable, CD4-T cell count always above 500.\n\nExclusion Criteria:\n\n1. Active opportunistic infection or systemic treatment for opportunistic infection within the last 4 months (oral candidiasis acceptable)\n2. Active treatment for cancer\n3. Active treatment for hepatitis C requiring interferon based therapy\n4. Immunosuppressive therapy taken within the last 4 months'}, 'identificationModule': {'nctId': 'NCT00187512', 'acronym': 'SCOPE', 'briefTitle': 'SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'SCOPE: Observational Study of the Consequences of the Protease Inhibitor Era', 'orgStudyIdInfo': {'id': '10-01330'}}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Hoh, M.S.', 'role': 'CONTACT', 'email': 'Rebecca.Hoh@ucsf.edu', 'phone': '415-476-4082', 'phoneExt': '139'}, {'name': 'Montha Pao', 'role': 'CONTACT', 'email': 'Montha.Pao@ucsf.edu', 'phone': '415-476-4082', 'phoneExt': '140'}, {'name': 'Steven G. Deeks, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Rebecca Hoh, M.S., R.D.', 'role': 'CONTACT', 'email': 'Rebecca.Hoh@ucsf.edu', 'phone': '415-476-4082', 'phoneExt': '139'}, {'name': 'Montha Pao', 'role': 'CONTACT', 'email': 'Montha.Pao@ucsf.edu', 'phone': '415-476-4082', 'phoneExt': '140'}], 'overallOfficials': [{'name': 'Steven G. Deeks, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}