protocolSection identificationModule nctId: NCT06338826, orgStudyIdInfo id: ANRS0250s-BI-LIGHT, briefTitle: 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, acronym: BI-LIGHT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: ANRS, Emerging Infectious Diseases, class: OTHER_GOV, descriptionModule briefSummary: 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, conditionsModule conditions: HIV Infections, conditions: HBV Coinfection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Interventional, sequential, Phase IIA equivalent, multicenter, open-label, randomized, non-comparative study evaluating, for 96 weeks, the safety in terms of HBV virological control of 2 antiviral therapy relief strategies, in HIV-1 and HBV co-infected patients with prolonged virological success (undetectable HIV-1 and HBV viral loads for ≥ 2 years) and on unmodified antiviral therapy for ≥ 1 year.Participants will be randomized 1:2:2 into 3 parallel arms:* Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF* Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days* 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). The choice of dual therapy is left to the discretion of the investigator., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI, interventions name: Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR), outcomesModule primaryOutcomes measure: The proportion of participants with HBV virological failure at 96 weeks., secondaryOutcomes measure: • HBV virological success rate at 48 weeks, secondaryOutcomes measure: • HIV virological success rate at 48 and 96 weeks, secondaryOutcomes measure: • Time to virological failure (rebound HBV and/or HIV viral load), secondaryOutcomes measure: • The rate of participants with at least one HBV viral load blip until W48 and until W96, secondaryOutcomes measure: • Selection of HBV resistance mutations at the time of virological failure, secondaryOutcomes measure: • Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96, secondaryOutcomes measure: • Evolution of CD4 from W0 to W48 and W96, secondaryOutcomes measure: • Evolution of total cholesterol from W0 to W48 and W96, secondaryOutcomes measure: • Evaluation of the adherence by self-reported questionnaire, secondaryOutcomes measure: • Evaluation of quality of life using the Pro-Qol self-questionnaire, secondaryOutcomes measure: Evolution of CD8 T lymphocytes from W0 to W48 and W96, secondaryOutcomes measure: Evolution of the CD4/CD8 ratio from W0 to W48 and W96, secondaryOutcomes measure: Evolution of LDL-c from W0 to W48 and W96, secondaryOutcomes measure: Evolution of HDL-c from W0 to W48 and W96, secondaryOutcomes measure: Evolution of triglycerides from W0 to W48 and W96, secondaryOutcomes measure: Evolution of fasting blood sugar from W0 to W48 and W96, secondaryOutcomes measure: HBV virological success rate at 96 weeks between arms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False