Interventional, multicenter, open-label, randomized, non-comparative trial evaluating the safety, in terms of HBV virological control, of 2 antiviral treatment relief strategies, in patients co-infected with the HIV-1 and HBV viruses
- Conditions
- co-infected with the HIV-1 and HBV virusesTherapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]Therapeutic area: Diseases [C] - Virus Diseases [C02]Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-508634-34-00
- Lead Sponsor
- Inserm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months), ALT < 3N at pre-inclusion, For women of childbearing potential, negative pregnancy test and commitment to use effective contraception throughout the trial, Person affiliated with or benefiting from a social security system, 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), Age = 18 years, Fibroscan less than 6 months < 9kPa, 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/r or INSTI to choose from oNNRTI = efavirenz, rilpivirine, etravirine, doravirine oPI/r = atazanavir/r ou darunavir/r oINSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir, 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), HIV CV < 50cp/ml for = 2 years (only 1 annual blip allowed if HIV CV < 200cp/ml and previous and subsequent viral loads are undetectable), HBV CV < 10 IU/ml for = 2 years (only 1 annual blip allowed if HBV CV < 200IU/ml and if previous and subsequent viral loads are undetectable), Have = 3 available measurements of HIV CV < 50cp/ml and HBV CV < 10 IU/mL over the past 24 months (including that of pre-inclusion, CD4 lymphocytes > 250/mm3 at pre-inclusion
HIV-2 infection, Any condition (drug use, neurological, neuropsychiatric, etc.) that, in the judgment of the investigator, may compromise patient compliance and adherence to the protocol, Pregnant or breastfeeding woman or refusal of contraception, Major incapacity, legal protection, guardianship or curatorship., HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC, HBeAg+., Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry = 9kPa, Chronic active viral hepatitis C (HCV RNA positive), Delta co-infection, Alcohol consumption > 14 units/week for women and 21 units/week for men, Current treatment with chemo- or immunotherapy (including interferon or interleukins), Active opportunistic infection or acute treatment for opportunistic infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method