Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Trea… (NCT06338826) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
140 participantsStarted 2025-02-01
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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);
Exclusion criteria
✕. HIV-2 infection;
✕. HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC;
✕. HBeAg+;
What they're measuring
1
The proportion of participants with HBV virological failure at 96 weeks.