[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100122840":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":32,"locations":38,"responsibleParty":121,"collaborators":123,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":136,"maxAge":32,"enrollmentInfo":137,"targetDuration":32,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":151,"whyStopped":32,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Fundacion SEIMC-GESIDA","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Lopinavir\u002Fritonavir (LPV\u002Fr) as single antiretroviral administered concomitantly with peg-interferon and ribavirin",[13],"Drug: Lopinavir\u002Fritonavir",{"label":15,"type":16,"description":17,"interventionNames":18},"2","ACTIVE_COMPARATOR","Lopinavir\u002Fritonavir (LPV\u002Fr) with 2 NRTIs, administered concomitantly with peg-interferon and ribavirin",[19],"Drug: Lopinavir\u002Fritonavir with two nucleoside analogs",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lopinavir\u002Fritonavir","NRTI sparing-regimen",[9],[27],"Kaletra",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Lopinavir\u002Fritonavir with two nucleoside analogs","LPV\u002Fr plus 2NRTIs + PEG-INF + RBV",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Enrique Ortega","Hospital General Universitario de Valencia","STUDY_CHAIR",[39,52,62,71,81,90,96,102,107,116],{"facility":40,"status":32,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":32},"Hospital Germans Trias i Pujol","Badalona","Barcelona","08910","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],2.24741,41.45004,{"lat":50,"lon":49},{"facility":53,"status":32,"city":54,"state":55,"zip":56,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":61,"contacts":32},"Hospital General de Castellón","Castellon","Castellón","12004",{"type":47,"coordinates":58},[59,60],-0.04935,39.98567,{"lat":60,"lon":59},{"facility":63,"status":32,"city":64,"state":65,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":66,"geoPoint":70,"contacts":32},"Hospital Donostia","Donostia \u002F San Sebastian","Guipuzcoa",{"type":47,"coordinates":67},[68,69],-1.97499,43.31283,{"lat":69,"lon":68},{"facility":72,"status":32,"city":73,"state":74,"zip":75,"country":44,"countryCode":45,"cosmosGeoPoint":76,"geoPoint":80,"contacts":32},"Hospital General Sta. Mª del Rosell","Cartagena","Murcia","30203",{"type":47,"coordinates":77},[78,79],-0.98397,37.60197,{"lat":79,"lon":78},{"facility":82,"status":32,"city":83,"state":32,"zip":84,"country":44,"countryCode":45,"cosmosGeoPoint":85,"geoPoint":89,"contacts":32},"Hospital Gregorio Marañón","Madrid","28007",{"type":47,"coordinates":86},[87,88],-3.70256,40.4165,{"lat":88,"lon":87},{"facility":91,"status":32,"city":83,"state":32,"zip":92,"country":44,"countryCode":45,"cosmosGeoPoint":93,"geoPoint":95,"contacts":32},"Hospital Ramón y Cajal","28034",{"type":47,"coordinates":94},[87,88],{"lat":88,"lon":87},{"facility":97,"status":32,"city":83,"state":32,"zip":98,"country":44,"countryCode":45,"cosmosGeoPoint":99,"geoPoint":101,"contacts":32},"Hospital la Paz","28046",{"type":47,"coordinates":100},[87,88],{"lat":88,"lon":87},{"facility":103,"status":32,"city":83,"state":32,"zip":32,"country":44,"countryCode":45,"cosmosGeoPoint":104,"geoPoint":106,"contacts":32},"Hospital La Princesa",{"type":47,"coordinates":105},[87,88],{"lat":88,"lon":87},{"facility":108,"status":32,"city":109,"state":32,"zip":110,"country":44,"countryCode":45,"cosmosGeoPoint":111,"geoPoint":115,"contacts":32},"Hospital La Fe","Valencia","46009",{"type":47,"coordinates":112},[113,114],-0.37966,39.47391,{"lat":114,"lon":113},{"facility":36,"status":32,"city":109,"state":32,"zip":117,"country":44,"countryCode":45,"cosmosGeoPoint":118,"geoPoint":120,"contacts":32},"46014",{"type":47,"coordinates":119},[113,114],{"lat":114,"lon":113},{"type":122,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[124],{"name":125,"class":126},"Abbott","INDUSTRY","100122840","phase-4-treatment-of-hivhcv-coinfection-with-peg-ifn-and-ribavirin-in-patients-receiving-art-monotherapy-with-lopinavirr-100122840",false,"NCT00866021","Treatment of HIV\u002FHCV Coinfection With Peg-IFN and Ribavirin in Patients Receiving ART Monotherapy With Lopinavir\u002Fr","A Multicenter, Randomized, Open Label, Pilot Study to Assess the Possibility of Concomitant Treatment of HCV\u002FHIV co Infection With Peg-interferon + Ribavirin, and Lopinavir\u002Fr as a Single Antiretroviral Agent.","PEKARI","Inclusion Criteria:\n\nSubjects must meet all the following criteria in the 30 days prior to study inclusion.\n\n1. Subject consent to participate in this study after being informed of all trial aspects that may influence his\u002Fher decision, given by signing and dating the informed consent form approved by the CREC of the corresponding center.\n2. Subject is at least 18 years old, is co-infected by HIV and HCV, and has been recommended treatment for HCV infection.\n3. Liver biopsy confirming the presence of chronic hepatitis performed within one year of patient entry into the study.\n4. Undetectable viral load (\\\u003C50 cop\u002FmL) during at least the 6 last months (confirmed). At least two viral load determinations lower than 50 cop\u002FmL 6 months apart are required. The inclusion of patients showing one single \"blip\" during the pre-enrollment past 6 months is allowed. A \"blip\" is defined as a HIV viral load greater or equal to 50 cop\u002FmL both preceded and followed of viral loads inferior to 50 cop\u002FmL without changes in the antiretroviral treatment.\n5. CD4 at screening should be at least or greater to 350 cells\u002Fmicrol\n6. Subject on continued, uninterrupted antiretroviral therapy for the past 6 months with\n\n   1. LPV\u002Fr + 2 NRTIs\u002FNtRTIs for at least 4 weeks;\n   2. 1 NNRTI + 2 NRTIs\n   3. 3 NRTIs Only changes in protease inhibitor due solely to toxicity, simplification, or optimization are acceptable\n7. Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.\n8. Subject has a Karnofsky index \\>-70.\n9. Throughout the study, the patient does not require and agrees not to take any of the following drugs, that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, methylergonovine), pimozide, propafenone, and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication due to the possibility of a significant decrease in Kaletra concentrations during concomitant administration.\n10. Subject agrees not to take any medication, including over-the-counter medicines, alcohol, drugs, or herbal preparations without the knowledge and approval of the principal investigator.\n11. Laboratory tests have been made in the subject in the past 30 days.\n12. Hemoglobin \\>8.0 g\u002FdL Absolute neutrophil count \\>750 cells\u002FmicroL Platelet count \\>20.000\u002FmicroL ALT or AST \\\u003C5 x upper normal limit (UNL) Creatinine \\\u003C1.5 x UNL\n13. Triglycerides \\\u003C750 mg\u002FdL.\n14. For women with childbearing potential, a negative result of a pregnancy test is available and they agree to use throughout the study at least two contraceptive methods (including a barrier one) of proven reliability in the investigator's opinion.\n15. In the case of men subjects, they are agreed to use during the hepatitis C treatment with ribavirin at least two contraceptive methods (including a barrier one).\n\nExclusion Criteria:\n\nSubjects will be excluded from study participation if they meet any of the following criteria:\n\n1. Subjects in whom a switch in protease inhibitor has ever been made due to suspected or documented virological failure.\n2. Subjects requiring treatment with drugs whose association with LPV\u002Fr is contraindicated based on Kaletra prescribing information..\n3. Active drug addiction or psychiatric disease that may prevent protocol compliance. Use of cannabis or being on methadone treatment are excepted, provided protocol compliance is not compromised in the investigator's opinion.\n4. Pregnancy or nursing, and in women of childbearing age, if they do not agree to use throughout the study a barrier contraceptive method of proven reliability in the investigator's opinion.\n5. In the opinion of the principal investigator, patient is unlikely to comply with the study protocol, or the patient was not eligible for any other reason.\n6. Subjects infected by the hepatitis B virus and who are being treated with tenofovir (TDF) or lamivudine (3TC).\n7. Prior treatment with interferon (pegylated or not) and\u002For ribavirin.","ALL","18 Years",{"count":138,"type":139},68,"ACTUAL","INTERVENTIONAL",[142],"PHASE4","The aim of this study is to assess the efficacy of lopinavir\u002Fr in monotherapy and peg-interferon plus ribavirin for the control of both HIV and HCV infection respectively after 12 months of active treatment for HCV.",[145,146],"HIV\u002FHCV Co-infection","HIV Infections",[148,149,150],"HIV infection","HCV infection","treatment experienced","COMPLETED","2025-03-14",{"date":154,"type":139},"2025-03-17",{"date":156,"type":32},"2008-02",{"date":158,"type":139},"2012-10",{"name":5,"class":6},10]