[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100240197":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":41,"centralContacts":32,"locations":49,"responsibleParty":85,"collaborators":32,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":32,"enrollmentInfo":97,"targetDuration":32,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":115,"whyStopped":32,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Sofosbuvir+Ribavirin","EXPERIMENTAL","Sofosbuvir 400mg QD (Sovaldi®) + Ribavirin weight-adjusted dosing (1000mg BID in patients \\\u003C 75kg and 1200mg BID in patients ≥ 75kg) in treatment-naïve patients infected with HCV genotype 2 (12-week course)",[13,14],"Drug: Sofosbuvir","Drug: Ribavirin",{"label":16,"type":10,"description":17,"interventionNames":18},"Sofosbuvir+Ledipasvir","Sofosbuvir\u002FLedipasvir 400mg\u002F90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)",[13,19],"Drug: Ledipasvir",[21,28,33,37],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sofosbuvir","Sofosbuvir 400mg QD (Sovaldi®) in treatment-naïve patients infected with HCV genotype 2 (12-week course)",[9],[27],"Sovaldi®",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ribavirin","Ribavirin weight-adjusted dosing (1000mg BID in patients \\\u003C 75kg and 1200mg BID in patients ≥ 75kg) in treatment-naïve patients infected with HCV genotype 2 (12-week course)",[9],null,{"type":22,"name":23,"description":17,"armGroupLabels":34,"otherNames":35},[16],[36],"Harvoni®",{"type":22,"name":38,"description":17,"armGroupLabels":39,"otherNames":40},"Ledipasvir",[16],[36],[42,46],{"name":43,"affiliation":44,"role":45},"Raoul Moh, Dr","Programme PACCI","STUDY_DIRECTOR",{"name":47,"affiliation":48,"role":45},"Babacar Sylla","Institut de Médecine et d'Epidémiologie Appliquée",[50,61,70,75],{"facility":51,"status":32,"city":52,"state":32,"zip":32,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":32},"Clinique de la Cathédrale","Yaoundé","Cameroon","CM",{"type":56,"coordinates":57},"Point",[58,59],11.51667,3.86667,{"lat":59,"lon":58},{"facility":62,"status":32,"city":63,"state":32,"zip":32,"country":64,"countryCode":32,"cosmosGeoPoint":65,"geoPoint":69,"contacts":32},"Centre de suivi des donneurs de sang","Abidjan","Côte d’Ivoire",{"type":56,"coordinates":66},[67,68],-4.00167,5.35444,{"lat":68,"lon":67},{"facility":71,"status":32,"city":63,"state":32,"zip":32,"country":64,"countryCode":32,"cosmosGeoPoint":72,"geoPoint":74,"contacts":32},"CHU de Youpougon - Service de Gastro-entéro-hépatologie",{"type":56,"coordinates":73},[67,68],{"lat":68,"lon":67},{"facility":76,"status":32,"city":77,"state":32,"zip":32,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":32},"CHU Fann, Service des Maladies Infectieuses","Dakar","Senegal","SN",{"type":56,"coordinates":81},[82,83],-17.44406,14.6937,{"lat":83,"lon":82},{"type":86,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100240197","phase-2-feasibility-tolerance-and-efficacy-of-interferon-free-antiviral-treatment-with-sofosbuvir--ribavirin-for-the-treatment-of-genotype-2-and-sofosbuvirledipasvir-for-the-treatment-of-genotype-1-and-4-hepatitis-c-virus-infected-patients-in-west-and-central-africa-100240197",false,"NCT02405013","Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir\u002FLedipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa","TAC (Treatment Africa Hepatitis C) : Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir\u002FLedipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa","TAC","Inclusion Criteria:\n\n* Age≥18 years\n* Confirmed G1, G2 or G4 HCV infection\n* Plasma HCV-RNA ≥1000 IU\u002FmL\n* No history of HCV treatment of any kind\n* Willingness to use a birth control method (hormonal or intrauterine device for women, condoms for men), starting before HCV treatment initiation and continued until 4months (women) and 7 months (men) after end of treatment.\n* Weight ≥40 kg and ≤125 kg\n\nFor patients infected with HIV :\n\n* Confirmed HIV-1 infection\n* Stable HIV treatment for at least 8 weeks with two NRTIs (tenofovir or abacavir, and lamivudine or emtricitabine) and a third agent (raltegravir, lopinavir\u002Fritonavir, atazanavir\u002Fritonavir, darunavir\u002Fritonavir, efavirenz, nevirapine)\n* Current CD4+ lymphocytes count ≥100\u002Fmm3\n* Current plasma HIV-1 RNA \\\u003C200 copies\u002FmL\n\nExclusion Criteria:\n\nFor each patient:\n\n* Cirrhosis classified Child-Pugh B or C\n* Co-infection by the Hepatitis B virus\n* Pregnant or breastfeeding ongoing\n* History of transplantation of organs or tissues\n* Progressive Cancer, including hepatocellular carcinoma\n* Epilepsy\n* Sickle Cell Disease\n* A history of myocardial infarction or other severe heart disease\n* Excessive consumption of alcohol or drug users, in the absence of substitution by methadone, a stable weaning for more than three months should be required\n* Ongoing Participation in another clinical trial\n* Contraindications to the Sofosbuvir as defined in the Summary of Product Characteristics\n* At least one of the following laboratory abnormalities:\n\nHaemoglobin \\\u003C10 g \u002F 100 ml (woman) \\\u003C11 g \u002F 100 ml (man) Platelet count \\\u003C50,000 \u002F mm3 polymorphonuclear neutrophils rate \\\u003C750 \u002F mm3 Creatinine clearance \\\u003C50ml \u002F min\n\nFor patients infected with HIV:\n\n* Severe opportunistic infections in the last 6 months\n* Poor adherence to antiretroviral treatment history\n* Use of antiretroviral drugs other than those permitted in the test","ALL","18 Years",{"count":98,"type":99},120,"ACTUAL","INTERVENTIONAL",[102],"PHASE2","Primary Objective:\n\nTo evaluate the efficacy (sustained virological response 12 weeks after end-of-treatment \\[SVR12\\]) of 12-week course of an interferon-free regimen combining sofosbuvir and weight-dosed ribavirin (genotype 2), or sofosbuvir and ledipasvir (genotype 1 or 4) in treatment-naïve patients infected with HCV genotype 1, 2 or 4 in West and Central Africa\n\nSecondary Objectives:\n\n1. To estimate the study treatment SVR24 rate\n2. To evaluate the clinical and biological tolerance of study treatment\n3. To describe HCV kinetics under HCV treatment, and identify associated factors\n4. To describe the evolution of HIV disease under HCV treatment in HVC-HIV co-infected patients\n5. To describe the changes of liver fibrosis based on non-invasive tests between treatment initiation, week 24, and week 36 after treatment, and estimate its association with SVR12 or SVR24\n6. To identify factors associated with SVR12 and SVR24 (including HIV status)\n7. To evaluate the performance of a nanodevice for rapid diagnosis of HCV viral load and genotypying and for assessing response to treatment (SVR12 and SVR24)\n8. Facilitate the detection and treatment of those infected with HCV by supporting national initiatives for access to strategies without interferon\n9. To set up a HCV clinical research network across French and English-speaking African countries, able to run large-scale comparative randomized clinical trials in a near future.",[105,106],"Hepatitis C","HIV Infection",[108,105,109,110,111,112,113,114],"Africa","HIV","Antiviral treatment","Adults","HCV genotype 1","HCV genotype 2","HCV genotype 4","COMPLETED","2017-12-12",{"date":118,"type":99},"2017-12-13",{"date":120,"type":99},"2015-10",{"date":122,"type":99},"2017-11",{"name":5,"class":6},4]