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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

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

Eligibility criteria

Qualifiers

HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months);

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

Disqualifiers

HIV-2 infection;

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;

Trial design

Treatments tested in this trial

  • TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI
  • Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)

Treatment groups

140 Participants
are divided into 3 treatment groups

Locations

This trial has no locations