Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT00051818
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2003-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune and Viral Outcomes of HIV-1 Therapy Interruption
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097042', 'term': 'Treatment Interruption'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D001294', 'term': 'Attitude to Health'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'completionDateStruct': {'date': '2003-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2003-01-16', 'studyFirstSubmitQcDate': '2003-01-23', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral suppression in the absence of therapy, compared to a structured treatment interruption (STI) group maintaining continual suppression'}], 'secondaryOutcomes': [{'measure': 'Safety of sequential STIs'}, {'measure': 'changes in immune reconstitution in relation to sequential STIs, including CD4 T-cell changes, recall responses, and T-cell activation, as measured by cell surface antigen changes'}, {'measure': 'genotypic changes occurring in HIV-1 protease and reverse transcriptase regions after sequential STIs and their relation to clinical failure under the ART regimen at study entry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic HIV infection', 'treatment interruption', 'HIV-specific immune response', 'immune response', 'virological response', 'treatment experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '11286710', 'type': 'BACKGROUND', 'citation': 'Montaner LJ. Structured treatment interruptions to control HIV-1 and limit drug exposure. Trends Immunol. 2001 Feb;22(2):92-6. doi: 10.1016/s1471-4906(00)01809-3.'}, {'pmid': '15630469', 'type': 'RESULT', 'citation': 'Papasavvas E, Kostman JR, Mounzer K, Grant RM, Gross R, Gallo C, Azzoni L, Foulkes A, Thiel B, Pistilli M, Mackiewicz A, Shull J, Montaner LJ. Randomized, controlled trial of therapy interruption in chronic HIV-1 infection. PLoS Med. 2004 Dec;1(3):e64. doi: 10.1371/journal.pmed.0010064. Epub 2004 Dec 28.'}, {'pmid': '14571185', 'type': 'RESULT', 'citation': 'Papasavvas E, Grant RM, Sun J, Mackiewicz A, Pistilli M, Gallo C, Kostman JR, Mounzer K, Shull J, Montaner LJ. Lack of persistent drug-resistant mutations evaluated within and between treatment interruptions in chronically HIV-1-infected patients. AIDS. 2003 Nov 7;17(16):2337-43. doi: 10.1097/00002030-200311070-00008.'}, {'pmid': '34049356', 'type': 'DERIVED', 'citation': 'Papasavvas E, Azzoni L, Ross BN, Fair M, Howell BJ, Hazuda DJ, Mounzer K, Kostman JR, Tebas P, Montaner LJ. Comparable HIV suppression by pegylated-IFN-alpha2a or pegylated-IFN-alpha2b during a 4-week analytical treatment interruption. AIDS. 2021 Oct 1;35(12):2051-2054. doi: 10.1097/QAD.0000000000002961.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if stopping anti-HIV drugs for a period of time is safe and effective for enhancing the immune function of patients with HIV.', 'detailedDescription': "Our preliminary studies have shown that structured treatment interruption of highly active antiretroviral therapy (HAART) may boost patients' immune responses to HIV-1. In this study, we will test the hypothesis that repeated structured treatment interruptions will increase HIV-1 immunity and result in better control of viral replication than in controls. We will test this hypothesis by determining time to viral rebound after withdrawal of antiretroviral therapy in a randomized, non-blinded study of a well-characterized subject population from a single center. Patients in this study will be randomized to either treatment interruption or control groups. Patients will be monitored for adherence to therapy and changes in immune status following HAART interruption. CD4 percentage, CD 4 and CD8 mediated anti-HIV-1 responses, cell surface T-cell antigen expression, and thymic function will be assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* HIV-1 positive\n* HIV RNA \\< 500 copies/ml on a regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) and either one protease inhibitor (PI) or one nonnucleoside reverse transcriptase inhibitor (NNRTI) for 6 months prior to study entry - HIV RNA \\< 50 copies/ml at study screening\n* CD4 \\> 400 cells/mm3 with CD4 nadir of \\> 100 cells/mm3\n* Agree to Medication Event Monitoring System monitoring of one component of antiretroviral regimen\n* HIV-1 viral load \\>10,000 copies/ml at any time prior to initiating the current uninterrupted HAART regimen\n* Willing to abstain from all immunomodulatory drugs during the study'}, 'identificationModule': {'nctId': 'NCT00051818', 'briefTitle': 'Immune and Viral Outcomes of HIV-1 Therapy Interruption', 'organization': {'class': 'OTHER', 'fullName': 'The Wistar Institute'}, 'officialTitle': 'Immune and Viral Outcomes of HIV-1 Therapy Interruption', 'orgStudyIdInfo': {'id': '5R01AI048398-01', 'link': 'https://reporter.nih.gov/quickSearch/5R01AI048398-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'AI048398'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Treatment interruption/reinitiation schedule', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Wistar Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Luis J. Montaner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Wistar Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Wistar Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director, HIV-1 Immunopathogenesis Laboratory', 'investigatorFullName': 'Luis Montaner', 'investigatorAffiliation': 'The Wistar Institute'}}}}