Adaptability of an Undetectable = Untransmissible Model for HBV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals above 18 years and less than 65 years with chronic hepatitis B infection
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
Disqualifiers
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
Trial population
Persons with chronic hepatitis B infection and active viremia
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
55 Participants
are grouped into 4 trial groupsGroup A: Anti-Viral Therapy
Group B: No Therapy
Group C: Convalesced
Group D: Healthy Controls
Trial outcomes
Primary outcomes
1
Percentage of Individuals with Detectable HBV DNA
Assessed among those who have achieved viral supression.
Time frame
Up to Month 62
HBV DNA Levels
Assessed among those with detectable HBV DNA.
Time frame
Up to Month 6Sponsors and contacts
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NYU Langone Health
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov