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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
55 Participants
are grouped into 4 trial groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov