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
Key facts
- Where
- Bobigny Cedex, Bondy, Bordeaux, Créteil, Dijon, Garches, Marseille, Montpellier Cedex 5, Nantes, Nice, Paris, Paris Cedex 12, Paris Cedex 13, Paris Cedex 20, St Denis, Toulouse és Tourcoing Cedex, FranciaországSee the 21 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Franciaország
- Hopital AvicenneBobigny Cedex, FranciaországTaking people
- Assistance Publique Hopitaux De ParisBondy, FranciaországTaking people
- Centre hospitalier Universitaire de BordeauxBordeaux, FranciaországTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranciaországTaking people
- CHU Dijon Bourgogne Hôpital François MitterandDijon, FranciaországTaking people
- Raymond-Poincare HospitalGarches, FranciaországTaking people
- Assistance Publique Hôpitaux de MarseilleMarseille, FranciaországTaking people
- CHRU MontpellierMontpellier Cedex 5, FranciaországTaking people
- Hospital Hotel DieuNantes, FranciaországTaking people
- Hôpital l'Archet 1Nice, FranciaországTaking people
- Hopital Bichat - Claude Bernard - AP-HPParis, FranciaországTaking people
- Hôpital LariboisièreParis, FranciaországTaking people
- Hopital Necker Enfants MaladesParis, FranciaországTaking people
- Hopital Saint LouisParis, FranciaországTaking people
- Hospital Hotel DieuParis, FranciaországTaking people
- Hopital Saint AntoineParis Cedex 12, FranciaországTaking people
- Hopital Universitaire Pitie SalpetriereParis Cedex 13, FranciaországTaking people
- Hopital TenonParis Cedex 20, FranciaországTaking people
- Centre Hospitalier Universitaire De La ReunionSt Denis, FranciaországTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranciaországTaking people
- Centre Hospitalier De TourcoingTourcoing Cedex, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Inserm
- Trial code
- EU 2023-508634-34-00
- Record updated
- 2026. október 23.
- Original description
The main objective of this trial is to evaluate at 96 weeks the safety with respect to chronic viral hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapyRead full original descriptionShow less
The main objective of this trial is to evaluate at 96 weeks the safety with respect to chronic viral hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy
Inclusion: HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months); 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 30 months (including that of pre-inclusion; CD4 lymphocytes > 250/mm3 at pre-inclusion; Positive Ag HBs HBV serology at pre-inclusion; 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 o NNRTI = efavirenz, rilpivirine, etravirine, doravirine o PI/r = atazanavir/r ou darunavir/r o INSTI = 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).
Exclusion: Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry ≥ 9kPa; Current treatment with chemo- or immunotherapy (including interferon or interleukins); 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; HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC; Chronic active viral hepatitis C (HCV RNA positive); Delta co-infection; Active opportunistic infection or acute treatment for opportunistic infection; Pregnant or breastfeeding woman or refusal of contraception; Major incapacity, legal protection, guardianship or curatorship; HBeAg+; Alcohol consumption > 14 units/week for women and 21 units/week for men.