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Taking people in FrancePhase 2

Tests two ways of lowering HIV medicine in adults with HIV and hepatitis B

Checks whether lowering HIV treatment stays safe for hepatitis B in adults.

Key facts

Who runs it
Inserm
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, and Tourcoing Cedex, FranceSee the 21 sites
Registry title
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
Status
Recruiting
Phase
Phase 2
People taking part
140 people, planned
Started
14 May 2025
Expected to end
30 Jun 2027
Type of study
Interventional
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults living with both HIV-1 and hepatitis B whose infections have been well controlled for years on a daily three-drug HIV treatment. It tests two ways of reducing that treatment.

Age
From 18 years (the record also lists a maximum age of 64 years).
Sex
All sexes can join.
Disease stage
HIV-1 and chronic hepatitis B together. HIV viral load below 50 cp/ml and HBV viral load below 10 IU/ml for at least 2 years. CD4 above 250/mm3. Liver stiffness (Fibroscan) below 9 kPa.
Earlier treatment
Must be on the same daily three-drug HIV treatment for at least 12 months. It must include tenofovir (TDF 245 mg or TAF 25 mg) with lamivudine or emtricitabine, plus one more HIV drug.
Biomarker or test result
Positive HBs antigen for hepatitis B. No known HIV or HBV resistance to the treatments tested. HBeAg must be negative.

Main reasons for not taking part

  • HIV-2 infection
  • Pregnant or breastfeeding, or refusing contraception
  • Hepatitis C with detectable virus, or hepatitis Delta co-infection
  • Liver scarring at stage F3-F4 or Fibroscan 9 kPa or more
  • Alcohol above 14 units/week for women or 21 units/week for men

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Check if you might fit

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 France

  • Hopital AvicenneBobigny Cedex, FranceTaking people
  • Assistance Publique Hopitaux De ParisBondy, FranceTaking people
  • Centre hospitalier Universitaire de BordeauxBordeaux, FranceTaking people
  • Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
  • CHU Dijon Bourgogne Hôpital François MitterandDijon, FranceTaking people
  • Raymond-Poincare HospitalGarches, FranceTaking people
  • Assistance Publique Hôpitaux de MarseilleMarseille, FranceTaking people
  • CHRU MontpellierMontpellier Cedex 5, FranceTaking people
  • Hospital Hotel DieuNantes, FranceTaking people
  • Hôpital l'Archet 1Nice, FranceTaking people
  • Hopital Bichat - Claude Bernard - AP-HPParis, FranceTaking people
  • Hôpital LariboisièreParis, FranceTaking people
  • Hopital Necker Enfants MaladesParis, FranceTaking people
  • Hopital Saint LouisParis, FranceTaking people
  • Hospital Hotel DieuParis, FranceTaking people
  • Hopital Saint AntoineParis Cedex 12, FranceTaking people
  • Hopital Universitaire Pitie SalpetriereParis Cedex 13, FranceTaking people
  • Hopital TenonParis Cedex 20, FranceTaking people
  • Centre Hospitalier Universitaire De La ReunionSt Denis, FranceTaking people
  • Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
  • Centre Hospitalier De TourcoingTourcoing Cedex, FranceTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests two ways of lowering HIV medicine in adults with HIV and hepatitis BGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2023-508634-34-00, who can take part
Record updated
23 October 2026