Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-29 @ 3:37 PM
Study NCT ID:
NCT00122668
Status:
TERMINATED
Last Update Posted:
2005-11-15
First Post:
2005-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D039682', 'term': 'HIV-Associated Lipodystrophy Syndrome'}], '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'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011480', 'term': 'Protease Inhibitors'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 112}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2005-07'}, 'lastUpdateSubmitDate': '2005-11-14', 'studyFirstSubmitDate': '2005-07-21', 'studyFirstSubmitQcDate': '2005-07-21', 'lastUpdatePostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96'}], 'secondaryOutcomes': [{'measure': 'During the study until 96 weeks'}, {'measure': 'Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml'}, {'measure': 'Evolution of viral load'}, {'measure': 'Evolution of CD4 lymphocytes'}, {'measure': 'Evaluation of clinical safety'}, {'measure': 'Evaluation of lipohypertrophic syndrome'}, {'measure': 'Evaluation of glucidic and lipids metabolic profile'}, {'measure': 'Evaluation of mitochondrial toxicity'}, {'measure': 'Evaluation of bone toxicity by measurement of bone density'}, {'measure': 'Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors'}, {'measure': 'Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors'}, {'measure': 'Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)'}]}, 'conditionsModule': {'keywords': ['HIV Protease Inhibitors', 'HIV-Associated Lipodystrophy Syndrome', 'HIV infections'], 'conditions': ['HIV Infections', 'HIV-Associated Lipodystrophy Syndrome']}, 'referencesModule': {'references': [{'pmid': '19487903', 'type': 'DERIVED', 'citation': 'Soulie C, Assoumou L, Ghosn J, Duvivier C, Peytavin G, Ait-Arkoub Z, Molina JM, Costagliola D, Katlama C, Calvez V, Marcelin AG. Nucleoside reverse transcriptase inhibitor-sparing regimen (nonnucleoside reverse transcriptase inhibitor + protease inhibitor) was more likely associated with resistance comparing to nonnucleoside reverse transcriptase inhibitor or protease inhibitor + nucleoside reverse transcriptase inhibitor in the randomized ANRS 121 trial. AIDS. 2009 Jul 31;23(12):1605-8. doi: 10.1097/QAD.0b013e32832d9031.'}, {'pmid': '19363330', 'type': 'DERIVED', 'citation': 'Duvivier C, Kolta S, Assoumou L, Ghosn J, Rozenberg S, Murphy RL, Katlama C, Costagliola D; ANRS 121 Hippocampe study group. Greater decrease in bone mineral density with protease inhibitor regimens compared with nonnucleoside reverse transcriptase inhibitor regimens in HIV-1 infected naive patients. AIDS. 2009 Apr 27;23(7):817-24. doi: 10.1097/QAD.0b013e328328f789.'}, {'pmid': '18641035', 'type': 'DERIVED', 'citation': 'Duvivier C, Ghosn J, Assoumou L, Soulie C, Peytavin G, Calvez V, Genin MA, Molina JM, Bouchaud O, Katlama C, Costagliola D; ANRS 121 study group. Initial therapy with nucleoside reverse transcriptase inhibitor-containing regimens is more effective than with regimens that spare them with no difference in short-term fat distribution: Hippocampe-ANRS 121 Trial. J Antimicrob Chemother. 2008 Oct;62(4):797-808. doi: 10.1093/jac/dkn278. Epub 2008 Jul 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).', 'detailedDescription': 'The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI.\n\nPatients were randomized (2:1:1) to either PI+NNRTI (Gp1) or standard therapy, 2NRTI+ either PI (Gp2) or + NNRTI (Gp3). The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.\n\nLipoatrophy is evaluated by evolution of subcutaneous fat in the limbs measured by DEXA (Dual Energy X-ray Absorptiometry)and CT-scan of the thighs between baseline and W96.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed HIV-1-infected diagnosis\n* Naive of antiretroviral treatment\n* Plasma viral load (VL) over 5000 copies/ ml\n* CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml\n* Written, informed consent after approval by the local human research ethics committee\n\nExclusion Criteria:\n\n* Acute opportunistic infection\n* Pregnancy or breast feeding\n* Cytotoxic systemic chemotherapy except for Kaposi sarcoma\n* Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study\n* Polynuclear neutrophils below 750/mm3\n* Hemoglobin below 8 g/dl\n* Platelets below 20 000/mm3\n* Creatinine level over 1.5 (upper normal) UN\n* ASAT, ALAT, bilirubin level over 3 UN'}, 'identificationModule': {'nctId': 'NCT00122668', 'briefTitle': 'Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121)', 'orgStudyIdInfo': {'id': 'ANRS121 HIPPOCAMPE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'non-nucleoside reverse transcriptase inhibitors', 'type': 'DRUG'}, {'name': 'nucleoside reverse transcriptase inhibitors', 'type': 'DRUG'}, {'name': 'protease inhibitor', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Claudine Duvivier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris'}, {'name': 'Dominique Costagliola', 'role': 'STUDY_CHAIR', 'affiliation': 'INSERM U 720'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}}}}