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Starting soon Observational

Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1

NCT06728917 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-20
Last updated
2024-12-11

Condition(s) studied

HBV (Hepatitis B Virus)HIV Infection

Study summary

The primary objective of the present project will be to investigate the risk of HBV reactivation (from virological reactivation to overt HBV infection) in HIV-1 carriers with occult HBV infection (OBI, is characterized by the absence of surface antigenemia, HBsAg negativity, with the presence of HBV-core antibody, HBcAb) and switching from antiretroviral therapy (ART) including nucleos(t)ides to long-acting formulation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \> 18 years * Informed consent to participate in the study * HIV infection * Stable antiretroviral therapy (ART) in the six months prior to enrollment without virological failure defined by HIV-RNA\>50 copies/mL in at least two consecutive determinations * Positive HBV anti-core antibodies (HBcAb) in the absence of hepatitis B surface antigen (HBsAg) * Absence of mutations associated with resistance to integrase inhibitors (INSTIs) and reverse transcriptase inhibitors (NNRTIs) by HIV genotypic resistance testing * CD4 Nadir \>200 cells/mm3 Exclusion Criteria: * Any contraindications to the use of one or more long-acting drugs * Non-expression or withdrawal of informed consent to participate in the study * Pregnancy * Lack of HIV genotypic resistance testing * Virological failure (HIV-RNA \>50 copies/mL in at least 2 consecutive determinations) in the 6 months prior to enrollment * Therapeutic interruptions in the six months prior to enrollment, excluding interruptions lasting less than a month due to tolerability * CD4 Nadir =\<200 cells/mm3 * Presence of biochemical signs of hepatocellular necrosis (AST, ALT \> normal values as indicated in laboratory tests). * Cirrhosis and/or fibrosis score \>F3 assessed by transient elastography (FibroScan).

Primary outcome measure(s)

  • Quantification of hepatitis B DNA (HBV-DNA) — Baseline (start of long-acting therapy) weeks 12, 24 and 48
    HBV-DNA increase respect to baseline viremia (=\>10 IU/mL) according to different time points (W12, W24, W48) after the start of LART.

Trial sites (3)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy
IRCCS San Raffaele O.U. Infectious Diseases Milan Italy
Università Luigi Vanvitelli della Campania Naples Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06728917 on ClinicalTrials.gov ↗ ← All trials in Italy