HBV (Hepatitis B Virus)OBILARTNCT06728917
Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1
An observational study of HBV (Hepatitis B Virus) and HIV Infection, run by IRCCS San Raffaele at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV (Hepatitis B Virus), HIV Infection
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- 20 Jan 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
IRCCS San Raffaele O.U. Infectious Diseases
Milan, 20127
Università Luigi Vanvitelli della Campania
Naples, 80138
About this study
Official title: Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients Living With HIV-1
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.
Read the detailed description
Observational prospective, multicenter, single-arm study with additional procedure in people living with HIV-1 and having serological markers of previous HBV infection: anti-core antibodies and/or antibodies against surface antigen (HBsAb) and switching from nucleoside analogue therapy to long-acting therapy including cabotegravir (CAB, HIV-1 integrase inhibitor) + rilpivirine (RPV, non-nucleoside HIV-1 reverse transcriptase inhibitor) intramuscularly 1 time every 2 months.
Primary Objective To study the risk of HBV reactivation from the phase of possible virological reactivation (HBV-DNA >=10 IU/mL), when the liver enzymes are within normal limits to overt HBV infection. Overt HBV infection is characterized by positive HBV-DNA, possible positivity of surface antigen (HBsAg) with or without altered liver enzymes in HIV-1 patients with OBI, with switch from ART, which includes nucleos(t)ide analogues active on the two HIV/HBV viruses, to the long-term formulation in which nucleos(t)ide analogues active on the two viruses are not included.
Secondary Objectives
- To evaluate the effect, in the context of HBV reactivation, of HBV-RNA as a surrogate marker of the transcriptional activity of the covalently closed circular (cccDNA) which is present as an HBV replication intermediate at the hepatocyte level.
- Examine the mutational profile of HBV domains (pre-S1 and S genes, X gene), mutations in the nucleocapsid promoter region and the pre-core/core variant, capable of influencing HBV replication efficiency, including also the analysis of mutants characterized as viral escape.
Exploratory Objectives To study the mutational profile of the regions of the hepatitis B virus (HBV) able to influence replication efficiency.
The study will include subjects living with HIV, followed at the San Luigi Center (Infectious Diseases), IRCCS Ospedale San Raffaele in Milan, Integrated Infectious Risk Management Department, Policlinico S. Orsola-Malpighi in Bologna, and the Department of Mental and Physical Health and Medicine prevention, University of Campania L. Vanvitelli of Naples, who agree to the switch from the current antiretroviral regimen which includes drugs active on HIV/HBV to long acting therapy.
- Conditions
- HBV (Hepatitis B Virus), HIV Infection
- Keywords
- Occult hepatitis B virus infection, long acting therapy, people living with HIV-1, HBV reactivation
- Medical subject headings
- Hepatitis B, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects living with HIV switching to long acting therapy | The study will include subjects living with HIV, followed at the San Luigi Center (Infectious Diseases), IRCCS Ospedale San Raffaele in Milan, Integrated Infectious Risk Management Department, Policlinico S. Orsola-Malpighi in Bologna, and the Department of Mental and Physical Health and Medicine prevention, University of Campania L. Vanvitelli of Naples, who agree to the switch from the current antiretroviral regimen which includes drugs active on HIV/HBV to long acting therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (start of long-acting therapy) weeks 12, 24 and 48
Secondary outcomes (2)
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).
Measured: Baseline and at weeks 12, 24 and 48
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
Measured: Baseline and at weeks 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start20 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HBV (Hepatitis B Virus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Campania Luigi Vanvitelli
- Responsible party
- Principal investigator, Castagna Antonella, IRCCS San Raffaele
- Investigators
- Antonella Castagna, Prof, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728917
- Sponsor's protocol ID
- IRCCS San Raffaele
- Acronym
- OBILART
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morsica G, Bagaglio S, Cicconi P, Capobianchi MR, Pellizzer G, Caramello P, Orani A, Moioli C, Rizzardini G, Uberti-Foppa C, Puoti M, Monforte AD; Hepa I.C.o.N.A the Icona Foundation Study Groups. Viral interference between hepatitis B, C, and D viruses in dual and triple infections in HIV-positive patients. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):574-81. doi: 10.1097/QAI.0b013e3181add592.
PubMed 19590432Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Espanol CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021 Nov;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5. Epub 2021 Oct 11.
PubMed 34648734Huang H, Wang J, Li W, Chen R, Chen X, Zhang F, Xu D, Lu F. Serum HBV DNA plus RNA shows superiority in reflecting the activity of intrahepatic cccDNA in treatment-naive HBV-infected individuals. J Clin Virol. 2018 Feb-Mar;99-100:71-78. doi: 10.1016/j.jcv.2017.12.016. Epub 2018 Jan 6.
PubMed 29353073Carey I, Gersch J, Wang B, Moigboi C, Kuhns M, Cloherty G, Dusheiko G, Agarwal K. Pregenomic HBV RNA and Hepatitis B Core-Related Antigen Predict Outcomes in Hepatitis B e Antigen-Negative Chronic Hepatitis B Patients Suppressed on Nucleos(T)ide Analogue Therapy. Hepatology. 2020 Jul;72(1):42-57. doi: 10.1002/hep.31026.
PubMed 31701544Bagaglio S, Bianchi G, Danise A, Porrino L, Uberti-Foppa C, Lazzarin A, Castagna A, Morsica G. Longitudinal evaluation of occult hepatitis B infection in HIV-1 infected individuals during highly active antiretroviral treatment interruption and after HAART resumption. Infection. 2011 Apr;39(2):121-6. doi: 10.1007/s15010-011-0093-9. Epub 2011 Mar 22.
PubMed 21424854Bagaglio S, Porrino L, Lazzarin A, Morsica G. Molecular characterization of occult and overt hepatitis B (HBV) infection in an HIV-infected person with reactivation of HBV after antiretroviral treatment interruption. Infection. 2010 Oct;38(5):417-21. doi: 10.1007/s15010-010-0032-1. Epub 2010 Jun 9.
PubMed 20533073Clark SJ, Creighton S, Horner M, Smith HM, Portmann B, Taylor C, Cramp ME. Reactivation of latent hepatitis B virus infection with HIV-related immunosuppression. Int J STD AIDS. 2006 Jan;17(1):67-9. doi: 10.1258/095646206775220612.
PubMed 16409685Chamorro AJ, Casado JL, Bellido D, Moreno S. Reactivation of hepatitis B in an HIV-infected patient with antibodies against hepatitis B core antigen as the only serological marker. Eur J Clin Microbiol Infect Dis. 2005 Jul;24(7):492-4. doi: 10.1007/s10096-005-1355-1.
PubMed 15990987Onorato L, Pisaturo M, Camaioni C, Grimaldi P, Codella AV, Calo F, Coppola N. Risk and Prevention of Hepatitis B Virus Reactivation during Immunosuppression for Non-Oncological Diseases. J Clin Med. 2021 Nov 8;10(21):5201. doi: 10.3390/jcm10215201.
PubMed 34768721Hu KQ. Occult hepatitis B virus infection and its clinical implications. J Viral Hepat. 2002 Jul;9(4):243-57. doi: 10.1046/j.1365-2893.2002.00344.x.
PubMed 12081601Mulrooney-Cousins PM, Michalak TI. Persistent occult hepatitis B virus infection: experimental findings and clinical implications. World J Gastroenterol. 2007 Nov 21;13(43):5682-6. doi: 10.3748/wjg.v13.i43.5682.
PubMed 17963292Ramezani A, Mohraz M, Aghakhani A, Banifazl M, Eslamifar A, Khadem-Sadegh A, Velayati AA. Frequency of isolated hepatitis B core antibody in HIV-hepatitis C virus co-infected individuals. Int J STD AIDS. 2009 May;20(5):336-8. doi: 10.1258/ijsa.2008.008377.
PubMed 19386971Pisaturo M, Onorato L, Russo A, Coppola N. Prevalence of occult HBV infection in Western countries. J Med Virol. 2020 Dec;92(12):2917-2929. doi: 10.1002/jmv.25867. Epub 2020 Jun 29.
PubMed 32275083Santos EA, Yoshida CF, Rolla VC, Mendes JM, Vieira IF, Arabe J, Gomes SA. Frequent occult hepatitis B virus infection in patients infected with human immunodeficiency virus type 1. Eur J Clin Microbiol Infect Dis. 2003 Feb;22(2):92-8. doi: 10.1007/s10096-002-0868-0. Epub 2003 Feb 18.
PubMed 12627282Nunez M, Rios P, Perez-Olmeda M, Soriano V. Lack of 'occult' hepatitis B virus infection in HIV-infected patients. AIDS. 2002 Oct 18;16(15):2099-101. doi: 10.1097/00002030-200210180-00024. No abstract available.
PubMed 12370518
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients Living With HIV-1
- ClinicalTrials.gov ID
- NCT06728917
- Acronym / sponsor ID
- OBILART / IRCCS San Raffaele
- Conditions
- HBV (Hepatitis B Virus), HIV Infection
- Keywords
- Occult hepatitis B virus infection, long acting therapy, people living with HIV-1, HBV reactivation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Campania Luigi Vanvitelli
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Observational prospective, multicenter, single-arm study with additional procedure in people living with HIV-1 and having serological markers of previous HBV infection: anti-core antibodies and/or antibodies against surface antigen (HBsAb) and switching from nucleoside analogue therapy to long-acting therapy including cabotegravir (CAB, HIV-1 integrase inhibitor) + rilpivirine (RPV, non-nucleoside HIV-1 reverse transcriptase inhibitor) intramuscularly 1 time every 2 months.
Primary Objective To study the risk of HBV reactivation from the phase of possible virological reactivation (HBV-DNA >=10 IU/mL), when the liver enzymes are within normal limits to overt HBV infection. Overt HBV infection is characterized by positive HBV-DNA, possible positivity of surface antigen (HBsAg) with or without altered liver enzymes in HIV-1 patients with OBI, with switch from ART, which includes nucleos(t)ide analogues active on the two HIV/HBV viruses, to the long-term formulation in which nucleos(t)ide analogues active on the two viruses are not included.
Secondary Objectives
- To evaluate the effect, in the context of HBV reactivation, of HBV-RNA as a surrogate marker of the transcriptional activity of the covalently closed circular (cccDNA) which is present as an HBV replication intermediate at the hepatocyte level.
- Examine the mutational profile of HBV domains (pre-S1 and S genes, X gene), mutations in the nucleocapsid promoter region and the pre-core/core variant, capable of influencing HBV replication efficiency, including also the analysis of mutants characterized as viral escape.
Exploratory Objectives To study the mutational profile of the regions of the hepatitis B virus (HBV) able to influence replication efficiency.
The study will include subjects living with HIV, followed at the San Luigi Center (Infectious Diseases), IRCCS Ospedale San Raffaele in Milan, Integrated Infectious Risk Management Department, Policlinico S. Orsola-Malpighi in Bologna, and the Department of Mental and Physical Health and Medicine prevention, University of Campania L. Vanvitelli of Naples, who agree to the switch from the current antiretroviral regimen which includes drugs active on HIV/HBV to long acting therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects living with HIV switching to long acting therapy | – | –The study will include subjects living with HIV, followed at the San Luigi Center (Infectious Diseases), IRCCS Ospedale San Raffaele in Milan, Integrated Infectious Risk Management Department, Policlinico S. Orsola-Malpighi in Bologna, and the Department of Mental and Physical Health and Medicine prevention, University of Campania L. Vanvitelli of Naples, who agree to the switch from the current antiretroviral regimen which includes drugs active on HIV/HBV to long acting therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantification of hepatitis B DNA (HBV-DNA)
Time frame: 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.
2 secondary outcomes
Quantification of hepatitis B RNA (HBV-RNA)
Time frame: Baseline and at weeks 12, 24 and 48
HBV mutational pattern by direct sequencing (Sanger)
Time frame: Baseline and at weeks 12, 24 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 19590432Morsica G, Bagaglio S, Cicconi P, Capobianchi MR, Pellizzer G, Caramello P, Orani A, Moioli C, Rizzardini G, Uberti-Foppa C, Puoti M, Monforte AD; Hepa I.C.o.N.A the Icona Foundation Study Groups. Viral interference between hepatitis B, C, and D viruses in dual and triple infections in HIV-positive patients. J Acquir Immune Defic Syndr. 2009 Aug 15;51(5):574-81. doi: 10.1097/QAI.0b013e3181add592.
- Background: PubMed 34648734Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Espanol CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021 Nov;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5. Epub 2021 Oct 11.
- Background: PubMed 29353073Huang H, Wang J, Li W, Chen R, Chen X, Zhang F, Xu D, Lu F. Serum HBV DNA plus RNA shows superiority in reflecting the activity of intrahepatic cccDNA in treatment-naive HBV-infected individuals. J Clin Virol. 2018 Feb-Mar;99-100:71-78. doi: 10.1016/j.jcv.2017.12.016. Epub 2018 Jan 6.
- Background: PubMed 31701544Carey I, Gersch J, Wang B, Moigboi C, Kuhns M, Cloherty G, Dusheiko G, Agarwal K. Pregenomic HBV RNA and Hepatitis B Core-Related Antigen Predict Outcomes in Hepatitis B e Antigen-Negative Chronic Hepatitis B Patients Suppressed on Nucleos(T)ide Analogue Therapy. Hepatology. 2020 Jul;72(1):42-57. doi: 10.1002/hep.31026.
- Background: PubMed 21424854Bagaglio S, Bianchi G, Danise A, Porrino L, Uberti-Foppa C, Lazzarin A, Castagna A, Morsica G. Longitudinal evaluation of occult hepatitis B infection in HIV-1 infected individuals during highly active antiretroviral treatment interruption and after HAART resumption. Infection. 2011 Apr;39(2):121-6. doi: 10.1007/s15010-011-0093-9. Epub 2011 Mar 22.
- Background: PubMed 20533073Bagaglio S, Porrino L, Lazzarin A, Morsica G. Molecular characterization of occult and overt hepatitis B (HBV) infection in an HIV-infected person with reactivation of HBV after antiretroviral treatment interruption. Infection. 2010 Oct;38(5):417-21. doi: 10.1007/s15010-010-0032-1. Epub 2010 Jun 9.
- Background: PubMed 16409685Clark SJ, Creighton S, Horner M, Smith HM, Portmann B, Taylor C, Cramp ME. Reactivation of latent hepatitis B virus infection with HIV-related immunosuppression. Int J STD AIDS. 2006 Jan;17(1):67-9. doi: 10.1258/095646206775220612.
- Background: PubMed 15990987Chamorro AJ, Casado JL, Bellido D, Moreno S. Reactivation of hepatitis B in an HIV-infected patient with antibodies against hepatitis B core antigen as the only serological marker. Eur J Clin Microbiol Infect Dis. 2005 Jul;24(7):492-4. doi: 10.1007/s10096-005-1355-1.
- Background: PubMed 34768721Onorato L, Pisaturo M, Camaioni C, Grimaldi P, Codella AV, Calo F, Coppola N. Risk and Prevention of Hepatitis B Virus Reactivation during Immunosuppression for Non-Oncological Diseases. J Clin Med. 2021 Nov 8;10(21):5201. doi: 10.3390/jcm10215201.
- Background: PubMed 12081601Hu KQ. Occult hepatitis B virus infection and its clinical implications. J Viral Hepat. 2002 Jul;9(4):243-57. doi: 10.1046/j.1365-2893.2002.00344.x.
- Background: PubMed 17963292Mulrooney-Cousins PM, Michalak TI. Persistent occult hepatitis B virus infection: experimental findings and clinical implications. World J Gastroenterol. 2007 Nov 21;13(43):5682-6. doi: 10.3748/wjg.v13.i43.5682.
- Background: PubMed 19386971Ramezani A, Mohraz M, Aghakhani A, Banifazl M, Eslamifar A, Khadem-Sadegh A, Velayati AA. Frequency of isolated hepatitis B core antibody in HIV-hepatitis C virus co-infected individuals. Int J STD AIDS. 2009 May;20(5):336-8. doi: 10.1258/ijsa.2008.008377.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonella Castagna, Prof, MD principal investigator
IRCCS San Raffaele
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV (Hepatitis B Virus) and HIV Infection, run by IRCCS San Raffaele at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonella Castagna, Prof, MD (+39 0226433473, castagna.antonella@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of hepatitis B DNA (HBV-DNA) (time frame: Baseline (start of long-acting therapy) weeks 12, 24 and 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728917, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.