Liver Diseases in PLWH
Epidemiological Investigation of HIV-infected Patients Complicated With Liver Disease in Zhejiang Province
1 other identifier
observational
3,000
1 country
1
Brief Summary
In Highly Active Antiretroviral Therapy era, fatty liver has become an important cause of liver function damage in people living with HIV (PLWH). There are a large number of PLWH in China who are infected with hepatitis B virus and hepatitis C virus. HIV, hepatitis B virus, hepatitis C virus, drugs, alcohol, etc. affect each other, which makes the cause, diagnosis, and treatment of liver function damage in PLWH complicated in China. The investigators plan to conduct a large-scale questionnaire survey among PLWH in Zhejiang Province to assess liver function, detect liver Injuries early, and analyze HIV, hepatitis B virus, hepatitis C virus, anti-HIV drugs, alcohol and other factors associate with liver injuries in PLWH, to provide basis for the treatment and prevention of liver disease in PLWH in eastern China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2020
CompletedFirst Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJune 30, 2020
June 1, 2020
3 months
June 22, 2020
June 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of liver disease in PLWH
The overall prevalence of liver disease in PLWH and the prevalence of hepatitis B, C, and fatty liver
2020-12-31
Eligibility Criteria
PLWH crowd in Zhejiang Province
You may qualify if:
- Age ≥18 years old;
- Non-hospitalized patients diagnosed with HIV infection;
- Sign the informed consent voluntarily.
You may not qualify if:
- Severe active infection requiring parenteral antibiotics or antifungal treatment within 30 days before the assessment;
- Other major chronic diseases that may affect health-related quality of life, such as extrahepatic malignant tumors;
- Psychotic patients, patients with severe cognitive or neurological deficits;
- Women during pregnancy and lactation;
- Those who refuse to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the first affiliated hospital of Zhejiang university school of medicine
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 24, 2020
Study Start
May 26, 2020
Primary Completion
August 31, 2020
Study Completion
December 30, 2020
Last Updated
June 30, 2020
Record last verified: 2020-06