Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT00312832
Status:
COMPLETED
Last Update Posted:
2006-10-24
First Post:
2006-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency 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': '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': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084862', 'term': 'Drug Tapering'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-01', 'completionDateStruct': {'date': '2005-02'}, 'lastUpdateSubmitDate': '2006-10-23', 'studyFirstSubmitDate': '2006-04-07', 'studyFirstSubmitQcDate': '2006-04-10', 'lastUpdatePostDateStruct': {'date': '2006-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HIV', 'd4T', 'TDF', 'lipoatrophy', 'treatment experienced', 'HIV-infection'], 'conditions': ['HIV Infections', 'Lipoatrophy']}, 'descriptionModule': {'briefSummary': 'Background: Stavudine-containing regimens are associated with a potential for lipoatrophy and dyslipidemia. We assessed the safety and efficacy of reducing the dose of stavudine compared to switching to tenofovir or maintaining the standard dose of stavudine.\n\nMethods: Clinically stable lipoatrophic HIV-infected patients receiving antiretroviral therapy containing stavudine 40 mg bid with a plasma HIV RNA \\<200 copies/mL for at least 6 months were randomized to maintain stavudine 40 mg bid (d4T40 arm), to reduce to 30 mg bid (d4T30 arm), or to switch from stavudine to tenofovir-DF (TDF arm) while preserving the remaining drugs. Fasting metabolic parameters were assessed at baseline and at weeks 4, 12, and 24. Mitochondrial parameters in peripheral blood mononuclear cells and body composition were measured at baseline and at week 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy eligibility criteria included documented HIV infection, age 18 years or older, moderate to severe clinical lipoatrophy in at least one region upon physical examination (17,18), viral load \\<200 copies/mL for at least 6 months prior to inclusion in the study, and a stable triple antiretroviral therapy including d4T 40 mg bid for at least the 6 preceding months, and no prior TDF use.\n\nExclusion Criteria:\n\nPrior TDF use, viral load\\>200 copies.'}, 'identificationModule': {'nctId': 'NCT00312832', 'briefTitle': 'Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'A Randomized Open Label Study Comparing the Impact of Reducing the Dose of Stavudine Versus Switching to Tenofovir on Plasma Lipids, Body Composition and Mitochondrial Function in HIV-Infected Patients Receiving Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'D40-30'}}, 'armsInterventionsModule': {'interventions': [{'name': 'switching; dose reduction', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jose Maria Gatell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}}}}