Actively Recruiting
Adaptability of an Undetectable = Untransmissible Model for HBV: Are Suppressed Viral Levels in the Serum Consistent Across Body Fluid Reservoirs?
Led by NYU Langone Health · Updated on 2026-05-15
55
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying chronic hepatitis B infection and active viremia, focusing on how viral levels in the blood and body fluids relate to the risk of transmitting the virus. The study aims to explore the concept of "Undetectable=Untransmissible" (U=U) for hepatitis B, which may help reduce anxiety and social isolation among infected individuals. The research includes people with chronic hepatitis B who are either on long-term anti-retroviral therapy or not receiving therapy, as well as those who have cleared the infection and healthy controls. Participants are divided into four groups: those infected and on anti-viral therapy with sustained viral suppression, infected individuals not receiving therapy (immune tolerant), individuals who have cleared the infection with no detectable virus, and healthy vaccinated controls who have never been infected. The study will monitor viral DNA levels in serum and various body fluids up to 6 months to assess the consistency of viral suppression across these reservoirs. During the study, participants will provide samples for viral DNA testing, and researchers will measure the percentage of individuals with detectable viral DNA and the actual viral levels. The study involves informed consent and includes adults aged 18 to 65 years. The findings aim to provide data on viral transmission risks and help support understanding of hepatitis B management over the 6-month observation period.
CONDITIONS
Brief Title
Adaptability of an Undetectable = Untransmissible Model for HBV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 years and older but less than 65 years
- Diagnosed with chronic hepatitis B infection or healthy vaccinated individuals who have never been infected
- For infected individuals on treatment: receiving TAF or TDF for at least 2 years with sustained viral suppression
- For infected individuals not on treatment: immune tolerant with high or low viral load as specified
- For convalesced individuals: prior infection with viral eradication and antibody development
- Able and willing to provide informed consent
You will not qualify if you...
- Individuals younger than 18 years or older than 65 years
- Prior surgery to the genitourinary tract, including vasectomy
- Prior interferon therapy
- Co-infection with HIV
- Co-infection with hepatitis C virus
- Co-infection with hepatitis delta virus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants are observed to assess HBV DNA levels and viral suppression status across different body fluid reservoirs.
Visits scheduled over 6 months to collect samples and monitor viral levels
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
A
AnnMarie Liapakis, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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