Clinical Trial

Adaptability of an Undetectable = Untransmissible Model for HBV

Recruiting
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-16
Trial Details
NCT Number NCT07449091
Lead Sponsor NYU Langone Health
Collaborators: Gilead Sciences
Conditions Chronic Hepatitis b, Viremia
Enrollment 55 participants
Start Date 2026-05-01
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-15