[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100225439":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":11,"locations":32,"responsibleParty":188,"collaborators":190,"id":196,"slug":197,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":11,"eligibilityCriteria":202,"healthyVolunteers":203,"sex":204,"minAge":205,"maxAge":11,"enrollmentInfo":206,"targetDuration":11,"studyType":209,"phases":210,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":222,"whyStopped":11,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"raltegravir and etravirine","EXPERIMENTAL",null,[13],"Drug: raltegravir and etravirine",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.\n\nEtravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.",[9],[20,24,28],{"name":21,"affiliation":22,"role":23},"Christine Katlama, MD","Service des Maladies Infectieuses et Tropicales, Groupe Hospitalier Pitié-Salpêtrière, Paris, France","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":26,"role":27},"Jacques Reynes, MD","Département des Maladies Infectieuses et Tropicales Hôpital Gui de Chauliac, CHU de Montpellier France","STUDY_CHAIR",{"name":29,"affiliation":30,"role":31},"Dominique Costagliola, PhD","Inserm UMR S 1136 Université Pierre et Marie Curie Epidémiologie, stratégies thérapeutiques et virologie cliniques dans l'infection à VIH, Paris, France","STUDY_DIRECTOR",[33,45,54,63,72,81,90,99,108,117,126,132,138,144,150,156,165,176,182],{"facility":34,"status":11,"city":35,"state":11,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":11},"Hôpital Avicenne","Bobigny","93000","France","FR",{"type":40,"coordinates":41},"Point",[42,43],2.45012,48.90982,{"lat":43,"lon":42},{"facility":46,"status":11,"city":47,"state":11,"zip":48,"country":37,"countryCode":38,"cosmosGeoPoint":49,"geoPoint":53,"contacts":11},"Hôpital Jean Verdier","Bondy","93140",{"type":40,"coordinates":50},[51,52],2.48931,48.9018,{"lat":52,"lon":51},{"facility":55,"status":11,"city":56,"state":11,"zip":57,"country":37,"countryCode":38,"cosmosGeoPoint":58,"geoPoint":62,"contacts":11},"Hôpital Saint André","Bordeaux","33076",{"type":40,"coordinates":59},[60,61],-0.58046,44.84124,{"lat":61,"lon":60},{"facility":64,"status":11,"city":65,"state":11,"zip":66,"country":37,"countryCode":38,"cosmosGeoPoint":67,"geoPoint":71,"contacts":11},"Hôpital Bicêtre","Le Kremlin-Bicêtre","94275",{"type":40,"coordinates":68},[69,70],2.36073,48.81471,{"lat":70,"lon":69},{"facility":73,"status":11,"city":74,"state":11,"zip":75,"country":37,"countryCode":38,"cosmosGeoPoint":76,"geoPoint":80,"contacts":11},"Hôpital Croix Rousse","Lyon","69317",{"type":40,"coordinates":77},[78,79],4.84789,45.74906,{"lat":79,"lon":78},{"facility":82,"status":11,"city":83,"state":11,"zip":84,"country":37,"countryCode":38,"cosmosGeoPoint":85,"geoPoint":89,"contacts":11},"Hôpital Sainte marguerite","Marseille","13009",{"type":40,"coordinates":86},[87,88],5.38107,43.29695,{"lat":88,"lon":87},{"facility":91,"status":11,"city":92,"state":11,"zip":93,"country":37,"countryCode":38,"cosmosGeoPoint":94,"geoPoint":98,"contacts":11},"Hôpital Gui de Chauliac","Montpellier","34000",{"type":40,"coordinates":95},[96,97],3.87635,43.61093,{"lat":97,"lon":96},{"facility":100,"status":11,"city":101,"state":11,"zip":102,"country":37,"countryCode":38,"cosmosGeoPoint":103,"geoPoint":107,"contacts":11},"CHU Hôtel Dieu","Nantes","44093",{"type":40,"coordinates":104},[105,106],-1.55336,47.21725,{"lat":106,"lon":105},{"facility":109,"status":11,"city":110,"state":11,"zip":111,"country":37,"countryCode":38,"cosmosGeoPoint":112,"geoPoint":116,"contacts":11},"Hôpital de l'Archet","Nice","06202",{"type":40,"coordinates":113},[114,115],7.26608,43.70313,{"lat":115,"lon":114},{"facility":118,"status":11,"city":119,"state":11,"zip":120,"country":37,"countryCode":38,"cosmosGeoPoint":121,"geoPoint":125,"contacts":11},"Hôpital Saint Louis","Paris","75010",{"type":40,"coordinates":122},[123,124],2.3488,48.85341,{"lat":124,"lon":123},{"facility":127,"status":11,"city":119,"state":11,"zip":128,"country":37,"countryCode":38,"cosmosGeoPoint":129,"geoPoint":131,"contacts":11},"Hôpital Pitié-Salpétrière","75013",{"type":40,"coordinates":130},[123,124],{"lat":124,"lon":123},{"facility":133,"status":11,"city":119,"state":11,"zip":134,"country":37,"countryCode":38,"cosmosGeoPoint":135,"geoPoint":137,"contacts":11},"Hôpital Cochin","75014",{"type":40,"coordinates":136},[123,124],{"lat":124,"lon":123},{"facility":139,"status":11,"city":119,"state":11,"zip":140,"country":37,"countryCode":38,"cosmosGeoPoint":141,"geoPoint":143,"contacts":11},"Hôpital Necker","75015",{"type":40,"coordinates":142},[123,124],{"lat":124,"lon":123},{"facility":145,"status":11,"city":119,"state":11,"zip":146,"country":37,"countryCode":38,"cosmosGeoPoint":147,"geoPoint":149,"contacts":11},"Hôpital Bichat Claude Bernard","75018",{"type":40,"coordinates":148},[123,124],{"lat":124,"lon":123},{"facility":151,"status":11,"city":119,"state":11,"zip":152,"country":37,"countryCode":38,"cosmosGeoPoint":153,"geoPoint":155,"contacts":11},"Hôpital Européen Georges Pompidou","75908",{"type":40,"coordinates":154},[123,124],{"lat":124,"lon":123},{"facility":157,"status":11,"city":158,"state":11,"zip":159,"country":37,"countryCode":38,"cosmosGeoPoint":160,"geoPoint":164,"contacts":11},"Hôpital Bretonneau","Tours","37044",{"type":40,"coordinates":161},[162,163],0.70398,47.39484,{"lat":163,"lon":162},{"facility":166,"status":11,"city":167,"state":11,"zip":168,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":175,"contacts":11},"Hospital de Bellvitge","Barcelona","08000","Spain","ES",{"type":40,"coordinates":172},[173,174],2.15899,41.38879,{"lat":174,"lon":173},{"facility":177,"status":11,"city":167,"state":11,"zip":178,"country":169,"countryCode":170,"cosmosGeoPoint":179,"geoPoint":181,"contacts":11},"Hospital de la santa Creu i San Pau","08025",{"type":40,"coordinates":180},[173,174],{"lat":174,"lon":173},{"facility":183,"status":11,"city":167,"state":11,"zip":184,"country":169,"countryCode":170,"cosmosGeoPoint":185,"geoPoint":187,"contacts":11},"Hospital Clinic","08036",{"type":40,"coordinates":186},[173,174],{"lat":174,"lon":173},{"type":189,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[191,194],{"name":192,"class":193},"Merck Sharp & Dohme LLC","INDUSTRY",{"name":195,"class":193},"Janssen-Cilag Ltd.","100225439","phase-2-capacity-of-the-dual-combination-raltegraviretravirine-to-maintain-virological-success-in-hiv-1-infected-patients-of-at-least-45-years-of-age--anrs-163-etral-100225439",true,"NCT02212379","Capacity of the Dual Combination Raltegravir\u002FEtravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL","Dual Therapy Combining Raltegravir With Etravirine Maintains a High Level of Viral Suppression Over 96 Weeks in Long-term Experienced HIV-infected Individuals Over 45 Years on a PI-based Regimen: Results From the Phase II ANRS 163 ETRAL Study","Inclusion Criteria:\n\n* Documented HIV-1 infection\n* Age ≥ 45 years\n* Naïve to integrase inhibitor and etravirine\n* At least 6 months of stable antiretroviral therapy (ART) including a boosted protease inhibitor, whatever the number of combined drugs\n* HIV-RNA plasma VL ≤ 50 copies\u002FmL during the last 24 months prior to screening visit (Week-6\u002FWeek-4), documented by at least 4 time-points with no more than one blip in HIV-RNA plasma viral load between 51 and 200 copies\u002FmL\n* HIV-RNA plasma VL ≤ 50 copies\u002FmL at screening visit (Week-6\u002FWeek-4)\n* A genotype is available (on amplified DNA at Week-6\u002FWeek-4 Visit and\u002For on RNA in the medical history of the patient) and shows a virus sensitive to ETR OR no genotype is available (amplification failure on DNA at Week-6\u002FWeek-4 Visit and no genotype in the medical history of the patient), there are no virological failure on NNRTI in the medical history\n* CD4+ lymphocytes \\> 200 cells\u002Fmm3\n* Creatinine \\\u003C 2.5 x ULN\n* CPK (Creatine Phospho Kinase) \\\u003C 6 ULN (Upper Limit of Normal)\n* AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) \\\u003C 5 ULN\n* Hemoglobin \\> 10 g\u002FdL\n* Platelets \\> 100 000\u002Fmm3\n* Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential\n* For French participants only: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme), article L1121-11 of the Public health code\n* Patients with a coverage from a social health\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous exposure to raltegravir or etravirine\n* Presence of any documented integrase inhibitor mutation on DNA genotype at Week-6\u002FWeek-4 and\u002For on RNA in the medical history of the patient\n* Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac\n* HIV-2 infection\n* Active viral hepatitis C requiring a specific treatment during the 24 months of the trial\n* Patient with a history of non-compliance or irregular follow-up\n* Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or antidiabetic treatment within the last 3 months prior the screening visit (Week-6 \u002FWeek-4)\n* Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®), Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® - Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John's wort, Carbamazepine (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra™), Triazolam (Halcion®)\n* Concomitant treatment using interferon, interleukins or any other immunotherapy or chemotherapy\n* Concomitant prophylactic or curative treatment for an opportunistic infection\n* All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and\u002For trial treatment tolerance\n* Subjects under judicial protection due to temporarily and slightly diminished mental or physical faculties, or under legal guardianship\n* Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase\n* Pregnant women or breastfeeding women",false,"ALL","45 Years",{"count":207,"type":208},170,"ACTUAL","INTERVENTIONAL",[211],"PHASE2","This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir\u002Fetravirine to maintain virological success in virologically suppressed HIV-1 infected patients, of at least 45 years of age, switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The primary endpoint was the proportion of participants with virological success at 48 weeks. Virological success is defined as the absence of 2 consecutive plasma viral load \\>50 copies\u002FmL within 2 to 4 weeks apart. The study was designed to show an efficacy \\>90%, assuming a success rate \\>95%, with a power of 80% and a 5%type-1 error. A total of 160 individuals was required to achieve the objective. The principal secondary endpoint is the proportion of patients in therapeutic success up to week 48 and 96.",[214],"HIV-1 Infection",[216,217,218,219,220,221],"Raltegravir","Etravirine","aged, 45 and over","Viral load","Efficacy","Safety","COMPLETED","2026-04-02",{"date":225,"type":208},"2026-04-03",{"date":227,"type":11},"2015-01",{"date":229,"type":208},"2018-04",{"name":5,"class":6},19]