Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
50 Participants
are grouped into 1 trial groupSponsors and collaborators
IRCCS San Raffaele
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
University of Campania Luigi Vanvitelli
Collaborator
Source ClinicalTrials.gov