Adaptability of an Undetectable = Untransmissible Model for HBV (NCT07449091) | Clinical Trial Compass
RecruitingNot Applicable
Adaptability of an Undetectable = Untransmissible Model for HBV
United States55 participantsStarted 2026-05-01
Plain-language summary
Persons with chronic hepatitis B (HBV) infection and active viremia are infectious and may transmit virus to others through blood/body fluid exposure. Immune tolerant treatment naive persons with hepatitis B infection express anxiety regarding disclosure of their infection status and significant fear of transmission to their partners leading to social isolation and impact on their personal lives. This study will provide data correlating serum and body fluid viral levels in persons with chronic hepatitis B infection not on therapy and those with viral suppression on long-term anti-retroviral therapy (ART) that may support the concept of "Undetectable=Untransmissible" (U=U) in patients with chronic hepatitis B.
Who can participate
Age range
18 Years – 65 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:
Infected Individuals
* Individuals above 18 years and less than 65 years with chronic hepatitis B infection
* Included according to undermentioned three arms:
* Infected, On-treatment arm: subjects being treated with TAF/TDF for a minimum of 2 years with sustained viral suppression indicating adherence to therapy
* Infected, Untreated control arm: Immune tolerant subjects; 15 with high viral load (\>10\^6) and 5 with low viral load (\<10\^6)
* Uninfected Assay Validation controls: 10 subjects with history of prior infection who have convalesced i.e., have lost surface antigen, and developed surface antibody with viral eradication
* Able and willing to provide informed consent
Healthy Controls
* Individuals above 18 years and less than 65 years who have never been infected and have been vaccinated
* Able and willing to provide informed consent
Exclusion Criteria:
* Individuals less than 18 years or greater than 65 years of age
* Prior surgery to genitourinary tract, including prior vasectomy
* Prior interferon therapy
* HIV co-infection
* Hepatitis C virus co-infection
* Hepatitis delta virus co-infection
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.