Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-03 @ 7:14 PM
Study NCT ID:
NCT00532168
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2007-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl
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': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'C098320', 'term': 'efavirenz'}, {'id': 'D061466', 'term': 'Lopinavir'}, {'id': 'C000718687', 'term': 'atazanavir, ritonavir drug combination'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011744', 'term': 'Pyrimidinones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-21', 'studyFirstSubmitDate': '2007-09-18', 'studyFirstSubmitQcDate': '2007-09-19', 'lastUpdatePostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['advanced HIV-infected patients', 'late presenters', 'antiretroviral therapy', 'immune reconstitution', 'Treatment Naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '25831464', 'type': 'DERIVED', 'citation': 'Miro JM, Manzardo C, Ferrer E, Lonca M, Guardo AC, Podzamczer D, Domingo P, Curran A, Clotet B, Cruceta A, Lozano F, Perez I, Plana M, Gatell JM; Advanz-3 Study Group. Immune Reconstitution in Severely Immunosuppressed Antiretroviral-Naive HIV-1-Infected Patients Starting Efavirenz, Lopinavir-Ritonavir, or Atazanavir-Ritonavir Plus Tenofovir/Emtricitabine: Final 48-Week Results (The Advanz-3 Trial). J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):206-15. doi: 10.1097/QAI.0000000000000567.'}]}, 'descriptionModule': {'briefSummary': 'There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic HIV-1 infection\n* Age 18 or more\n* Antiretroviral-naive\n* Baseline CD4+ count \\<100 cels/mcL.\n* No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)\n* Written informed consent\n\nExclusion Criteria:\n\n* Hypersensibility to study drugs.\n* Pregnancy or breastfeeding\n* Active OI requiring admission\n* Active lymphoma or malignancy (Kaposi sarcoma included)\n* Cl creatinine below 30 ml/min.\n* Liver failure\n* Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.'}, 'identificationModule': {'nctId': 'NCT00532168', 'acronym': 'ADVANZ-3', 'briefTitle': 'Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.', 'orgStudyIdInfo': {'id': 'ADVANZ-3'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2006-006268-42'}, {'id': 'FIS grant: EC07/90642'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'tenofovir plus emtricitabine plus efavirenz', 'interventionNames': ['Drug: tenofovir + emtricitabine + efavirenz']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'tenofovir plus emtricitabine plus lopinavir-ritonavir', 'interventionNames': ['Drug: tenofovir + emtricitabine + lopinavir-ritonavir']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'tenofovir plus emtricitabine plus atazanavir-ritonavir', 'interventionNames': ['Drug: tenofovir + emtricitabine + atazanavir-ritonavir']}], 'interventions': [{'name': 'tenofovir + emtricitabine + efavirenz', 'type': 'DRUG', 'description': 'tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD', 'armGroupLabels': ['1']}, {'name': 'tenofovir + emtricitabine + lopinavir-ritonavir', 'type': 'DRUG', 'description': 'tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose', 'armGroupLabels': ['2']}, {'name': 'tenofovir + emtricitabine + atazanavir-ritonavir', 'type': 'DRUG', 'description': 'tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Jose M Miró, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juan A. Arnaiz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Juan A. Arnaiz', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}