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
This trial does not accept healthy volunteersQualifiers
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 population
50 subjects will participate to the study, 30 subjects enrolled at the San Luigi Center (Unit of Infectious Diseases), IRCCS Ospedale San Raffaele in Milan, 10 subjects enrolled at Integrated Infectious Risk Management Department, Policlinico S. Orsola-Malpighi in Bologna, and 10 at the Department of Mental and Physical Health and Medicine prevention, University of Campania L. Vanvitelli of Naples.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: Subjects living with HIV switching to long acting therapy
Trial outcomes
Primary outcomes
1
Quantification of hepatitis B DNA (HBV-DNA)
HBV-DNA increase respect to baseline viremia (=\>10 IU/mL) according to different time points (W12, W24, W48) after the start of LART.
Time frame
Baseline (start of long-acting therapy) weeks 12, 24 and 48Secondary outcomes
1
Quantification of hepatitis B RNA (HBV-RNA)
any concomitant HBV-RNA increase respect to baseline value by measurement of HBV- RNA at different time points (W12, W24, W48).
Time frame
Baseline and at weeks 12, 24 and 482
HBV mutational pattern by direct sequencing (Sanger)
the mutational pattern of HBV genome (S, pre-C/C, X and polymerase regions) will be evaluated in positive HBV-DNA samples
Time frame
Baseline and at weeks 12, 24 and 48Other outcomes
1
Measurement of number of amino acid and/or nucleotide substitution.
Measurement of number of amino acid and/or nucleotide substitution tostudy the mutational profile of the regions of the hepatitis B virus (HBV) able to influence replication efficiency.
Time frame
Baseline (start of long-acting therapy) weeks 12, 24 and 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS San Raffaele
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
University of Campania Luigi Vanvitelli
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: