[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542127":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":39,"locations":12,"responsibleParty":49,"collaborators":12,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":12,"enrollmentInfo":61,"targetDuration":12,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":12,"overallStatus":71,"whyStopped":12,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":12},{"fullName":5,"class":6},"ANRS, Emerging Infectious Diseases","OTHER_GOV",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","NO_INTERVENTION","\\- Arm 1 (reference arm): Continuation of continuous (7 days\u002Fweek) triple antiviral therapy including TDF or TAF",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Arm 2 (T4):","EXPERIMENTAL","\\- Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days",[18],"Drug: TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI\u002Fr or INSTI",{"label":20,"type":15,"description":21,"interventionNames":22},"Arm 3 (B7)","Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR",[23],"Drug: Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)",[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":12},"DRUG","TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI\u002Fr or INSTI","The study will include patients under current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI\u002Fr or INSTI to choose from\n\n* NNRTI = efavirenz, rilpivirine, etravirine, doravirine\n* PI\u002Fr = atazanavir\u002Fr ou darunavir\u002Fr\n* INSTI = bictegravir, dolutegravir, elvitegravir\u002Fcobicistat, raltegravir",[14],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":12},"Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)","dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR",[20],[35],{"name":36,"affiliation":37,"role":38},"Julie Bottero","Bicetre Hospital","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Fatoumata COULIBALY","CONTACT","0144236110","+33","fatoumata.coulibaly@anrs.fr",{"name":47,"role":42,"phone":12,"phoneExt":44,"email":48},"Karine Amat","karine.amat@fondation-imea.org",{"type":50,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100542127","phase-2-study-evaluating-the-safety-in-terms-of-hbv-virological-control-at-96-weeks-of-2-antiviral-treatment-relief-strategies-in-patients-co-infected-with-the-hiv-1-and-hbv-viruses-100542127",false,"NCT06338826","Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses","Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses","BI-LIGHT","Inclusion Criteria:\n\n1. HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months);\n2. Age ≥ 18 years\n3. Fibroscan less than 6 months \\\u003C 9kPa\n4. Current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI\u002Fr or INSTI to choose from\n\n   * NNRTI = efavirenz, rilpivirine, etravirine, doravirine\n   * PI\u002Fr = atazanavir\u002Fr ou darunavir\u002Fr\n   * INSTI = bictegravir, dolutegravir, elvitegravir\u002Fcobicistat, raltegravir;\n5. Absence of documented HBV and HIV genotypic resistance compromising virologic control of any of the maintenance strategies. Patients with no genotypic history may be included);\n6. HIV CV \\\u003C 50cp\u002Fml for ≥ 2 years (only 1 annual blip allowed if HIV CV \\\u003C 200cp\u002Fml and previous and subsequent viral loads are undetectable);\n7. HBV CV \\\u003C 10 IU\u002Fml for ≥ 2 years (only 1 annual blip allowed if HBV CV \\\u003C 200IU\u002Fml and if previous and subsequent viral loads are undetectable);\n8. Have ≥ 3 available measurements of HIV CV \\\u003C 50cp\u002Fml and HBV CV \\\u003C 10 IU\u002FmL over the past 24 months (including that of pre-inclusion);\n9. CD4 lymphocytes \\> 250\u002Fmm3 at pre-inclusion;\n10. ALT \\\u003C 3N at pre-inclusion;\n11. For women of childbearing potential, negative pregnancy test and commitment to use effective contraception throughout the trial;\n12. Person affiliated with or benefiting from a social security system;\n13. Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study (article L1122-1-1 of the Public Health Code)\n\nExclusion Criteria:\n\n1. HIV-2 infection;\n2. HIV and\u002For HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC;\n3. HBeAg+;\n4. Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and\u002For fibroscan with a value of Elastometry ≥ 9kPa;\n5. Chronic active viral hepatitis C (HCV RNA positive);\n6. Delta co-infection;\n7. Alcohol consumption \\> 14 units\u002Fweek for women and 21 units\u002Fweek for men;\n8. Current treatment with chemo- or immunotherapy (including interferon or interleukins);\n9. Active opportunistic infection or acute treatment for opportunistic infection;\n10. Any condition (drug use, neurological, neuropsychiatric, etc.) that, in the judgment of the investigator, may compromise patient compliance and adherence to the protocol;\n11. Pregnant or breastfeeding woman or refusal of contraception;\n12. Major incapacity, legal protection, guardianship or curatorship","ALL","18 Years",{"count":62,"type":63},140,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy",[69,70],"HIV Infections","HBV Coinfection","NOT_YET_RECRUITING","2025-02-03",{"date":74,"type":75},"2025-02-05","ACTUAL",{"date":77,"type":63},"2025-02-01",{"date":79,"type":63},"2027-09-30",{"name":5,"class":6}]