Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-04-01 @ 6:07 PM
Study NCT ID:
NCT00148850
Status:
TERMINATED
Last Update Posted:
2005-10-20
First Post:
2005-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D039682', 'term': 'HIV-Associated Lipodystrophy Syndrome'}, {'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': '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'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 130}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2004-10'}, 'lastUpdateSubmitDate': '2005-10-19', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2005-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)'}], 'secondaryOutcomes': [{'measure': 'Changes from inclusion to week 48:'}, {'measure': 'Lipid profile and the glucidic metabolism'}, {'measure': 'SAT/TAT and VAT/TAT ratios evaluated with scanner'}, {'measure': 'X ray of L4'}, {'measure': 'Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)'}, {'measure': 'Evaluation of clinical and biological safety'}]}, 'conditionsModule': {'keywords': ['HIV-Associated Lipodystrophy Syndrome', 'pioglitazone', 'HIV infections', 'Treatment Experienced'], 'conditions': ['HIV-Associated Lipodystrophy Syndrome', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '18389900', 'type': 'DERIVED', 'citation': 'Slama L, Lanoy E, Valantin MA, Bastard JP, Chermak A, Boutekatjirt A, William-Faltaos D, Billaud E, Molina JM, Capeau J, Costagliola D, Rozenbaum W. Effect of pioglitazone on HIV-1-related lipodystrophy: a randomized double-blind placebo-controlled trial (ANRS 113). Antivir Ther. 2008;13(1):67-76.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.', 'detailedDescription': 'Lipodystrophy is one of the most frequent treatment side effect in HIV-1 infected patients. This complication can be stigmatizing in some affected patients and lead to reduced adherence to treatment, increased risk of cardiovascular complications and induce insulinoresistance. The pathophysiology of lipodystrophy remains poorly understood. Some antiretroviral drugs could be involved. Therefore, using PPAR G as a therapeutic target with the objective to reverse drug induced lipoatrophy appeared as a promising objective Thiazolidinediones are a new class of insulin sensitizing drugs for the treatment of type 2 diabetes. These PPARG agonist which mainly promote the differentiation of adipocytes, decrease circulating plasma free fatty acids. In non-HIV infected patients this class of drugs decreases intraabdominal fat accumulation and increases subcutaneous fat depot.\n\nDifferent previous studies were performed with that aim, most of them using rosiglitazone.\n\nWe designed a prospective randomized, double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of ages and older\n* Confirmed laboratory diagnosis of HIV-1-infection\n* Karnofsky equal or over 70%\n* Patients treated with stable antiretroviral therapy for at least 6 months\n* Plasma viral load below 400 copies/ ml and CD4 count over 200/mm3 for at least 6 months\n* Patients with a clinical peripheral lipoatrophy self reported by the patient and confirmed by physical examination\n\nExclusion Criteria:\n\n* Cachexia\n* Cardiac failure class3 or 4 at NYHA classification\n* Acute opportunistic infection\n* Pregnancy or breast-feeding\n* Polynuclear neutrophils below 1000/mm3\n* Hemoglobin below 9 g/dl\n* Platelets below 50 000/mm3\n* Creatinine level over 2 UN\n* ASAT, ALAT over 2.5UN\n* Bilirubin, amylase, lipase level over 2 UN\n* CD4 count below 200/mm3\n* Patients treated by any antidiabetic or lipid lowering drugs, anabolic or corticosteroid hormone'}, 'identificationModule': {'nctId': 'NCT00148850', 'briefTitle': 'Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral Therapy for at Least 6 Months.ANRS 113 LIPIOT Study', 'orgStudyIdInfo': {'id': 'ANRS 113 LIPIOT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pioglitazone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Service des Maladies Infectieuses et Tropicales, Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Willy Rozenbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Tenon 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'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}]}}}