NCT06728917Not yet recruiting
Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1
Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients Living With HIV-1
Source: ClinicalTrials.gov · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- 20 Jan 2025
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Hepatitis B, HIV
- NCT number
- NCT06728917
What you commit to
- Study type: Observational
- Planned participants: 50
- From 20 Jan 2025 to the primary completion date, 30 Apr 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindications to the use of one or more long-acting drugs
- 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
Other illness
- Lack of HIV genotypic resistance testing
Lab values
- Presence of biochemical signs of hepatocellular necrosis (AST, ALT \> normal values as indicated in laboratory tests).
Other
- Non-expression or withdrawal of informed consent to participate in the study
- Pregnancy
- CD4 Nadir =\<200 cells/mm3
- Cirrhosis and/or fibrosis score \>F3 assessed by transient elastography (FibroScan).
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| IRCCS San Raffaele O.U. Infectious Diseases Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Università Luigi Vanvitelli della Campania Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.