Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-29 @ 12:48 AM
Study NCT ID:
NCT01453933
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2011-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RAltegravir Switch STudy: Effects on Endothelial Recovery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-17', 'studyFirstSubmitDate': '2011-10-10', 'studyFirstSubmitQcDate': '2011-10-13', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in flow mediated dilatation (FMD) of the brachial artery', 'timeFrame': 'week 8, week16', 'description': 'Change in flow-mediated dilatation (FMD) of the brachial artery after 8 weeks of raltegravir treatment as compared to the control group (treatment with lopinavir/ritonavir)'}], 'secondaryOutcomes': [{'measure': 'Change in markers of chronic inflammation', 'timeFrame': 'Baseline, week 2, week 4, week 8, week 10, week 12 and week 16'}, {'measure': 'Change in markers of immune activation', 'timeFrame': 'Baseline, week 2, week 4, week 8, week 10, week 12 and week 16'}, {'measure': 'Change in markers of endothelial function', 'timeFrame': 'Baseline, week 2, week 4, week 8, week 10, week 12 and week 16'}, {'measure': 'Changes in plasma HIV-RNA below 50 copies/ml', 'timeFrame': 'Baseline, week 8, week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anti-HIV Agents', 'Anti-Retroviral Agents', 'Antiviral Agents', 'Anti-Infective Agents', 'Lopinavir/ritonavir'], 'conditions': ['HIV Infection', 'Endothelial Dysfunction']}, 'referencesModule': {'references': [{'pmid': '29770748', 'type': 'DERIVED', 'citation': 'Krikke M, Tesselaar K, van den Berk GEL, Otto SA, Freriks LH, van Lelyveld SFL, Visseren FJL, Hoepelman AIM, Arends JE. The effect of switching protease inhibitors to raltegravir on endothelial function, in HIV-infected patients. HIV Clin Trials. 2018 Apr;19(2):75-83. doi: 10.1080/15284336.2018.1455366.'}]}, 'descriptionModule': {'briefSummary': 'Treatment with HIV-infection with protease inhibitors is associated with high blood lipids and higher chance for cardiovascular complications. The RASSTER study aims to investigate the effect of switching the protease inhibitor lopinavir/ritonavir to raltegravir on vessel wall function and inflammation,and activation of the immune system. we hypothesize that with this intervention these parameters will improve. Since decreased vessel wall function and inflammation are initial steps in the process of atherosclerosis, it is important to know this data when treating HIV-infected patients.', 'detailedDescription': 'Fixed dose combination lopinavir/ritonavir (LPV/r) is a widespread used antiretroviral drug belonging to the class of protease inhibitors (PIs). PIs are associated with an increased risk of myocardial infarction. However, data is available suggesting increased levels of plasma lipids are not the sole explanation for this observation. Treatment with LPV/r might lead to a decrease of endothelial function as well, thus explaining the increased risk of myocardial infarction besides increased plasma lipids. Raltegravir is a registered antiretroviral drug with no known cardiovascular side effects. We hypothesize that switching LPV/r to raltegravir in HIV-infected patients with suppressed plasma viral load (\\<50 copies/ml) will lead to an improvement of endothelial function.\n\nObjective:\n\n* First, to assess the effect of the switch of lopinavir/ritonavir to raltegravir on endothelial function.\n* Second, to assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on plasma HIV-RNA below the cut-off of 50 copies/ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* HIV-1 infection\n* Treatment with antiretroviral regimen containing lopinavir/ritonavir for at least the previous 3 months\n* No other protease inhibitors besides lopinavir/ritonavir in antiretroviral regimen\n* Subjects must have a minimum period of viral suppression (plasma HIV-RNA \\< 50 copies/ml) of 6 months\n* Subjects will not have a history of virological failure on antiretroviral therapy\n* Results of previous resistance testing allowing replacement of lopinavir/ritonavir by raltegravir\n* CD4+ cell count \\> 200 cells/µL\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Raltegravir hypersensitivity\n* Treatment of underlying malignancy\n* Renal insufficiency requiring dialysis\n* Acute or decompensated chronic hepatitis (Child-Pugh score C)\n* Modification of antiretroviral regimen in the previous 3 months'}, 'identificationModule': {'nctId': 'NCT01453933', 'acronym': 'RASSTER', 'briefTitle': 'RAltegravir Switch STudy: Effects on Endothelial Recovery', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Phase IV, Randomized, Open Label, Crossover, Intervention Trial to Investigate the Effect of the Switch of Lopinavir/Ritonavir to Raltegravir on Endothelial Function, Chronic Inflammation, Immune Activation and HIV Replication <50 Copies/ml', 'orgStudyIdInfo': {'id': 'RASSTER2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Raltegravir', 'description': 'At baseline, lopinavir-ritonavir will be switched to raltegravir (cross-over after 8 weeks).', 'interventionNames': ['Drug: raltegravir']}, {'type': 'NO_INTERVENTION', 'label': 'Lopinavir/ritonavir', 'description': 'Subjects will continue lopinavir/ritonavir (cross-over after 8 weeks)'}], 'interventions': [{'name': 'raltegravir', 'type': 'DRUG', 'otherNames': ['Isentress'], 'description': 'Switch of lopinavir/ritonavir to raltegravir 400 mg BID (duration 8 weeks)', 'armGroupLabels': ['Raltegravir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1091 AC', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Guido van den Berk, MD, PhD', 'role': 'CONTACT', 'email': 'G.E.L.vandenBerk@olvg.nl'}], 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3584CX', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Steven FL van Lelyveld, MD', 'role': 'CONTACT', 'email': 's.f.l.vanlelyveld@umcutrecht.nl'}, {'name': 'Andy IM Hoepelman, MD, PhD', 'role': 'CONTACT', 'email': 'i.m.hoepelman@umcutrecht.nl'}, {'name': 'Steven FL van Lelyveld, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andy IM Hoepelman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Steven FL van Lelyveld, MD', 'role': 'CONTACT', 'email': 's.f.l.vanlelyveld@umcutrecht.nl'}, {'name': 'Andy IM Hoepelman, MD, PhD', 'role': 'CONTACT', 'email': 'i.m.hoepelman@umcutrecht.nl'}], 'overallOfficials': [{'name': 'Andy IM Hoepelman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Utrecht, The Netherlands'}, {'name': 'Steven FL van Lelyveld, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Center Utrecht, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'S.F.L. van Lelyveld', 'investigatorAffiliation': 'UMC Utrecht'}}}}