Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:21 AM
Study NCT ID:
NCT00135460
Status:
UNKNOWN
Last Update Posted:
2006-03-14
First Post:
2005-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D039682', 'term': 'HIV-Associated Lipodystrophy Syndrome'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], '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': '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'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2007-11'}, 'lastUpdateSubmitDate': '2006-03-13', 'studyFirstSubmitDate': '2005-08-25', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2006-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in peripheral fat mass, determined by DEXA-changes'}, {'measure': 'Changes in body composition from baseline, determined by patient and physician in a standardized questionnaire and by standardized clinical examination'}, {'measure': 'Change from baseline in fasting lipids and subsets hereof'}, {'measure': 'Development of impaired glucose tolerance and insulin resistance'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with HIV-RNA < 20 copies after 24, 48, 72 and 96 weeks'}, {'measure': 'Change in CD4 cell count from baseline after 24, 48, 72 and 96 weeks'}, {'measure': 'Incidence of adverse events'}, {'measure': 'Incidence of clinical disease progression'}, {'measure': 'Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96'}, {'measure': 'Change in plasma lactate from baseline'}, {'measure': 'Time to discontinuation of the randomized therapy and reasons for this'}, {'measure': 'Incidence of genotypical and virological resistance'}, {'measure': 'Development of osteopenia, judged by DEXA-scan'}, {'measure': 'Compliance - proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96'}]}, 'conditionsModule': {'keywords': ['HIV', 'Lipoatrophy', 'Lipodystrophy', 'Treatment Naive', 'HIV Infections', 'Hypercholesterolemia'], 'conditions': ['HIV-Associated Lipodystrophy Syndrome']}, 'referencesModule': {'references': [{'pmid': '28399815', 'type': 'DERIVED', 'citation': 'Mathiesen IH, Salem M, Gerstoft J, Gaardbo JC, Obel N, Pedersen C, Ullum H, Nielsen SD, Hansen AE. Complete manuscript Title: Changes in RANKL during the first two years after cART initiation in HIV-infected cART naive adults. BMC Infect Dis. 2017 Apr 11;17(1):262. doi: 10.1186/s12879-017-2368-y.'}]}, 'descriptionModule': {'briefSummary': 'Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy.\n\nThere is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy.\n\nThe researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen.\n\nThe main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Antiretroviral naïve patients\n* HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.\n* Fulfilling the criteria for starting antiretroviral therapy.\n* Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Women being pregnant or breast-feeding.\n* Fertile women using no safe contraception.\n* Patients with active intravenous drug use.\n* Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.\n* Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz.\n* Creatinine \\> 200 mmol/l.\n* ALT or AST \\> 5 times upper normal value (200U/l).'}, 'identificationModule': {'nctId': 'NCT00135460', 'briefTitle': 'Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in HIV Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Danish HIV Research Group'}, 'officialTitle': 'Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.', 'orgStudyIdInfo': {'id': '2612-2198'}}, 'armsInterventionsModule': {'interventions': [{'name': 'nucleoside analogue sparing HAART regimen', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Infectious Diseases, Hvidovre University Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Department of Infectious Diseases, Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Infectious Diseases, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Infectious Diseases, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Department of Infectious Diseases, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jan Gerstoft, M.D., DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}, {'name': 'Niels Obel, M.D., DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}, {'name': 'Court Pedersen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}, {'name': 'Lars Mathiesen, M.D.,DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hvidovre University Hospital'}, {'name': 'Henrik Nielsen, M.D.,DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University Hospital'}, {'name': 'Alex Laursen, M.D., DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University City'}, {'name': 'Ann-Brit E Hansen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital Rigshospitalet and Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish HIV Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, {'name': 'Abbott', 'class': 'INDUSTRY'}]}}}