Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 11:51 PM
Study NCT ID:
NCT00114933
Status:
COMPLETED
Last Update Posted:
2008-03-21
First Post:
2005-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2007-05'}, 'lastUpdateSubmitDate': '2008-03-20', 'studyFirstSubmitDate': '2005-06-20', 'studyFirstSubmitQcDate': '2005-06-20', 'lastUpdatePostDateStruct': {'date': '2008-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% patients with therapeutic failure in both arms at 48 weeks (OT and ITT)'}], 'secondaryOutcomes': [{'measure': '% patients with virological failure: HIV-RNA > 500 cop/ml under the randomly assigned therapy (OT and ITT)'}, {'measure': '% patients with HIV RNA < 500 cop/ml and < 50 cop/ml at w24, w48 (OT and ITT)'}, {'measure': 'Time to virological failure per Kaplan Meyer analysis'}, {'measure': 'CD4 cell count change from baseline'}, {'measure': 'Percentage of viruses with resistance in the protease gene at w24 and w48'}, {'measure': 'Description of AEs with probable, possible or unknown relationship to study drug'}]}, 'conditionsModule': {'keywords': ['HIV', 'AIDS', 'Treatment Experienced'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '19349870', 'type': 'DERIVED', 'citation': 'Arribas JR, Delgado R, Arranz A, Munoz R, Portilla J, Pasquau J, Perez-Elias MJ, Iribarren JA, Rubio R, Ocampo A, Sanchez-Conde M, Knobel H, Arazo P, Sanz J, Lopez-Aldeguer J, Montes ML, Pulido F; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. J Acquir Immune Defic Syndr. 2009 Jun 1;51(2):147-52. doi: 10.1097/QAI.0b013e3181a56de5.'}, {'pmid': '18097218', 'type': 'DERIVED', 'citation': 'Pulido F, Arribas JR, Delgado R, Cabrero E, Gonzalez-Garcia J, Perez-Elias MJ, Arranz A, Portilla J, Pasquau J, Iribarren JA, Rubio R, Norton M; OK04 Study Group. Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two nucleosides for maintenance therapy of HIV. AIDS. 2008 Jan 11;22(2):F1-9. doi: 10.1097/QAD.0b013e3282f4243b.'}]}, 'descriptionModule': {'briefSummary': 'Lopinavir/ritonavir monotherapy may maintain virologic suppression in patients who have been undetectable for six months while on triple drug antiretroviral therapy. Lopinavir/ritonavir pharmacokinetics might prevent resistance development in patients who experience virological rebound after single-drug simplification.', 'detailedDescription': 'Primary Study Objective: Efficacy and durability of switching to lopinavir/ritonavir single-drug HAART compared to maintaining therapy based on lopinavir/ritonavir and two nucleosides\n\nSecondary Study Objective(s):\n\n* Safety (related drug AEs/SAEs and laboratory anomalies G3/4) through 48 w.\n* Resistance profile on patients with sustained virological failure\n* QOL comparing stopping nucleosides versus continuing therapy\n* Pharmaco-economic analysis comparing treatment cost between the 2 study arms.\n* Predicting factors of failure in the stopping nucleosides arm\n\nSubject Population: 200 patients\n\nStudy Design:\n\nRANDOMIZATION:\n\nPatients are randomized (1:1) either to continue under the same treatment or stop nucleosides as follows:\n\n* Stopping nucleosides arm: Lopinavir/r alone.\n* Continuing arm: Lopinavir/r + 2 NRTIs\n\nSTUDY PROCEDURES: A baseline HIV-RNA, CD4 and routine labs will be collected if the most recent results are not collected within the 4 weeks prior entering the study. Patients will be followed for HIV-RNA (and CD4) at w1, w4, w8, w16, w24, w 36 and w48. After w48, durability of response to lopinavir/r single-drug therapy will be studied long-term (up to w96). Routine hematology and clinical chemistry (including fasting triglycerides and cholesterol, total and HDL/LDL ratio) will be measured at w4, w16, w24, w 36 and w48. A central laboratory will be used for HIV-RNA determinations and to archive plasma/cell samples for further genotype test in case of rebound.\n\nTreatment adherence will be followed with a self-patient report questionnaire (GEEMA study)\n\nAll AEs will be collected if suspected relation (possible or probable) to any concomitant ARV drug, and SAEs, related or not, reported within 24h.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV patients \\> 18 years old who provide signed and dated Informed consent.\n* HIV patients who have been receiving lopinavir/ritonavir and two nucleosides during at least 4 weeks.\n* Plasma HIV RNA \\< 50 cop/ml for six months\n\nExclusion Criteria:\n\n* HIV patients who have stopped a protease inhibitor due to virological failure.\n* HIV patients with hepatic or renal insufficiency.\n* HIV patients with positive serum HBVAg\n* HIV patients who require treatment with a lopinavir/r contraindicated medication.\n* HIV pregnant or breastfeeding women.\n* Active drug abuse (including alcohol or recreational drugs). Exception, cannabis, provided the investigator is confident in patient adherence. Patients under Methadone program will be accepted too if deemed appropriate by the investigator.'}, 'identificationModule': {'nctId': 'NCT00114933', 'briefTitle': '"OK 2004 Study" (Only Kaletra 2004 Study): Study to Evaluate Suspending Nucleosides From Triple-Drug Therapy in HIV Subjects', 'organization': {'class': 'INDIV', 'fullName': 'Arribas, Jose R., M.D.'}, 'officialTitle': 'Phase III-IV, Comparative, Randomized, Open-Label, Study to Evaluate Safety and Efficacy of Suspending Nucleosides From a Triple-Drug Therapy Based on Lopinavir/Ritonavir Versus Continuing Triple-Drug Therapy in HIV-Infected Subjects With Undetectable Plasma HIV Viremia for Six Months', 'orgStudyIdInfo': {'id': 'SPA-378-05-40'}, 'secondaryIdInfos': [{'id': 'EudraCT 2004-001323-37'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Stopping nucleosides and continuing lopinavir/ritonavir monotherapy', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03010', 'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '03202', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'zip': '08003', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '35500', 'city': 'Las Palmas de Gran Canaria', 'state': 'Gran Canaria', 'country': 'Spain', 'facility': 'Hospital Insular', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '18014', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'Hospital Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '20014', 'city': 'San Sebastián', 'state': 'Guipuzcoa', 'country': 'Spain', 'facility': 'Hospital de Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'zip': '28880', 'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital U. Príncipe de Asturias', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'zip': '28 046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28006', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '362004', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Hospital Xeral Cies', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '41009', 'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'Hospital Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41014', 'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora de Valme (Sevilla)', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'state': 'Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46017', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Dr. Peset', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '48013', 'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '50010', 'city': 'Zaragoza', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'José R. Arribas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital La Paz'}, {'name': 'Federico Pulido, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital 12 de Octubre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arribas, Jose R., M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'Pulido, Federico, M.D.', 'class': 'INDIV'}, {'name': 'Abbott', 'class': 'INDUSTRY'}]}}}