Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-26 @ 9:57 PM
Study NCT ID:
NCT00385957
Status:
COMPLETED
Last Update Posted:
2010-12-15
First Post:
2006-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'lastUpdateSubmitDate': '2010-12-14', 'studyFirstSubmitDate': '2006-10-10', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.'}, {'measure': 'Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.'}], 'secondaryOutcomes': [{'measure': 'Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive'}, {'measure': 'CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)'}, {'measure': 'and levels of CD8 cells (CD28+ y CD38+)'}, {'measure': 'Incidence of adverse events'}]}, 'conditionsModule': {'keywords': ['Treatment Naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '20624069', 'type': 'DERIVED', 'citation': 'Miro JM, Manzardo C, Pich J, Domingo P, Ferrer E, Arribas JR, Ribera E, Arrizabalaga J, Lonca M, Cruceta A, de Lazzari E, Fuster M, Podzamczer D, Plana M, Gatell JM; Advanz Study Group. Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial. AIDS Res Hum Retroviruses. 2010 Jul;26(7):747-57. doi: 10.1089/aid.2009.0105.'}]}, 'descriptionModule': {'briefSummary': 'The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 \\< 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed HIV-1 infection.\n* Age 18 years or over.\n* No previous antiretroviral therapy.\n* CD4 lymphocyte count of \\< 100 cells/mL.\n* Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.\n\nExclusion Criteria:\n\n* Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.\n* Currently undergoing treatment for an opportunistic infection (parenteral administration).\n* Any formal contraindication to treatment with the study drugs'}, 'identificationModule': {'nctId': 'NCT00385957', 'briefTitle': 'Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3', 'orgStudyIdInfo': {'id': 'ADVAN-Z'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AZT+3TC+IDV+RTV', 'type': 'DRUG'}, {'name': 'AZT+3TC+EFV', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'CSU Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '20014', 'city': 'Donostia / San Sebastian', 'state': 'Giputzkoa', 'country': 'Spain', 'facility': 'Donostia Ospitaleak', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Jose M Gatell, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}}}}