Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-29 @ 2:45 AM
Study NCT ID:
NCT00122551
Status:
TERMINATED
Last Update Posted:
2005-08-01
First Post:
2005-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy (HAART)
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-07', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2005-07-28', 'studyFirstSubmitDate': '2005-07-19', 'studyFirstSubmitQcDate': '2005-07-19', 'lastUpdatePostDateStruct': {'date': '2005-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study'}], 'secondaryOutcomes': [{'measure': '1993 Centers for Disease Control (CDC) classification of HIV infection B or C events'}, {'measure': 'Proportions of patients with CD4 count over 450/µl at week 96'}, {'measure': 'Proportions of patients with plasma HIV load over 400 and 1000/ml thresholds'}, {'measure': 'Plasma and peripheral blood mononuclear cells (PBMC) HIV resistance patterns'}, {'measure': 'Proportions of patients withdrawing initial treatment strategy'}, {'measure': 'Assessment of lipodystrophy and metabolic abnormalities'}, {'measure': 'Antiretroviral therapy (ARTs) adherence assessment'}, {'measure': 'Quality of life assessment'}, {'measure': 'Cost impact of the strategies'}]}, 'conditionsModule': {'keywords': ['HIV infections'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '21738752', 'type': 'DERIVED', 'citation': 'Delobel P, Saliou A, Nicot F, Dubois M, Trancart S, Tangre P, Aboulker JP, Taburet AM, Molina JM, Massip P, Marchou B, Izopet J; ANRS 106-Window Study Team. Minor HIV-1 variants with the K103N resistance mutation during intermittent efavirenz-containing antiretroviral therapy and virological failure. PLoS One. 2011;6(6):e21655. doi: 10.1371/journal.pone.0021655. Epub 2011 Jun 27.'}, {'pmid': '18931625', 'type': 'DERIVED', 'citation': 'Charreau I, Jeanblanc G, Tangre P, Boyer L, Saouzanet M, Marchou B, Molina JM, Aboulker JP, Durand-Zaleski I; ANRS 106 Study Group. Costs of intermittent versus continuous antiretroviral therapy in patients with controlled HIV infection: a substudy of the ANRS 106 Window Trial. J Acquir Immune Defic Syndr. 2008 Dec 1;49(4):416-21. doi: 10.1097/QAI.0b013e31818a657c.'}]}, 'descriptionModule': {'briefSummary': 'Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern. The purpose of this study is to compare an intermittent therapy strategy to a continuous treatment in patients with chronic and well controlled HIV-1 infection.', 'detailedDescription': 'Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern.\n\nThe purpose of this study is to compare an intermittent therapy (IT) strategy (8 weeks off / 8 weeks on) to a continuous treatment (CT) in patients with chronic and well controlled HIV-1 infection (CD4 over 450/µl and plasma HIV1-RNA below 200 cp/ml) under HAART, over a 96-week study period.\n\nThe study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300/µl. It will compare the proportions of and time to immunological failure (CD4 count below 300/µl confirmed by a retest 14 days later) in the IT and CT groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection\n* CD4 cell count over 450/µl for at least 6 months prior to screening\n* Plasma HIV1-RNA below 200 cop/ml for at least 6 months prior to screening\n* Stable and well tolerated ART for at least 6 months prior to screening\n* Acceptable methods of contraception\n* Patient able to comply with the protocol\n* Informed consent signed prior to (or at) screening\n\nExclusion Criteria:\n\n* CD4 nadir below 100/µl\n* Abacavir or nevirapine in the current ART\n* Hepatitis B with 3-TC, adefovir or tenofovir current therapy\n* Current or upcoming treatment with interferon for hepatitis B or C\n* History of AIDS-defining event in the 18 months prior to screening\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT00122551', 'briefTitle': 'Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy (HAART)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'A Prospective, Randomized, Multicenter Trial of Intermittent Therapy in HIV-Infected Patients With Successful Viral Suppression Under HAART (ANRS 106 Window Trial)', 'orgStudyIdInfo': {'id': 'ANRS 106 Window'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intermittent antiretroviral therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Service des Maladies Infectieuses', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Service des Maladies Infectieuses et Tropicales Hopital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Bruno Marchou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service des Maladies Infectieuses et Tropicales Hopital Purpan Toulouse'}, {'name': 'Jean Pierre Aboulker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Inserm SC10'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}}}}