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Adaptability of an Undetectable = Untransmissible Model for HBV

NYU Langone Health · with Gilead Sciences · NCT07449091

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
55
US sites recruiting
1
Study start
May 1, 2026
Record last updated
May 15, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Chronic Hepatitis b; Viremia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

Study contacts (from the official record)

  • AnnMarie Liapakis, MD · 212-263-3751 · AnnMarie.Liapakis@nyulangone.org
All healthy volunteers studies in New York →
Adaptability of an Undetectable = Untransmissible Model for HBV (NCT07449091) | Bored Studies