Adaptability of an Undetectable = Untransmissible Model for HBV: Are Suppressed Viral Levels in the Serum Consistent Across Body Fluid Reservoirs?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Percentage of Individuals with Detectable HBV DNA
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Anti-Viral Therapy
Infected individuals on anti-viral therapy.
No Therapy
Infected individuals who are not receiving anti-viral therapy.
Convalesced
Individuals who have cleared HBV infection.
Healthy Controls
Individuals who are uninfected.
结局指标
主要结局
Percentage of Individuals with Detectable HBV DNA
时间窗: Up to Month 6
Assessed among those who have achieved viral supression.
HBV DNA Levels
时间窗: Up to Month 6
Assessed among those with detectable HBV DNA.
次要结局
未报告次要终点