Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in… (NCT06728917) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1
Italy50 participantsStarted 2025-01-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of hepatitis B DNA (HBV-DNA)
Timeframe: Baseline (start of long-acting therapy) weeks 12, 24 and 48