[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hbv-coinfection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hbv-coinfection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100625994","changes-in-bile-acids-and-microbiota-in-patients-with-hepatitis-d-treated-with-bulvertide-100625994",false,"NCT07429864","Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide","Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection","Bio-Delta","Inclusion Criteria:\n\n* Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A)\n* Positive HDV RNA within the 24 weeks prior to enrollment\n* Ongoing antiviral therapy for HBV at the time of enrollment\n* First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment\n* Caucasian ethnicity\n* Age ≥18 years\n* Normocaloric omnivorous diet\n* No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis (Child-Pugh Score B or C)\n* Patients without HBV-HDV-related infection\u002Fhepatitis\u002Fcirrhosis\n* Age ≤18 years\n* Pregnant or breastfeeding women\n* Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III\u002FIV, COPD GOLD C-D)\n* Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","OBSERVATIONAL","HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.",[25,26,27,28,29,30,31,32,33],"HBV","HBV Coinfection","HCV","HIV Infections","Hepatocellular Carcinoma","Cirrhosis, Liver","Fibrosis, Liver","Bile Acid Malabsorption","Microbial Colonization",[35,36,37],"gut microbiota","Bile Acids","dysbiosis","RECRUITING","2026-02-17",{"date":41,"type":42},"2026-02-24","ACTUAL",{"date":44,"type":42},"2025-09-24",{"date":46,"type":21},"2027-10",{"name":48,"class":49},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"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","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",{"count":60,"type":21},140,"INTERVENTIONAL",[63],"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",[28,26],"NOT_YET_RECRUITING","2025-02-03",{"date":69,"type":42},"2025-02-05",{"date":71,"type":21},"2025-02-01",{"date":73,"type":21},"2027-09-30",{"name":75,"class":76},"ANRS, Emerging Infectious Diseases","OTHER_GOV"]