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Recruiting

NCT Number: NCT07449091

Adaptability of an Undetectable = Untransmissible Model for HBV

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Individuals with Detectable HBV DNA

    Time frame: Up to Month 6

    Assessed among those who have achieved viral supression.

  2. HBV DNA Levels

    Time frame: Up to Month 6

    Assessed among those with detectable HBV DNA.

Study contacts

Contact information is provided by the study sponsor or research team.

AnnMarie Liapakis, MD

CONTACT

[email protected]

212-263-3751

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

Adaptability of an Undetectable = Untransmissible Model for HBV: Are Suppressed Viral Levels in the Serum Consistent Across Body Fluid Reservoirs?

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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