Liver Diseases in PLWH

• Conditions: Liver Diseases; HIV/AIDS

• Registration Number: NCT04446156
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-26
• Status Verified: 2020-06
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Age ≥18 years old;
• Non-hospitalized patients diagnosed with HIV infection;
• Sign the informed consent voluntarily.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of liver disease in PLWH	2020-12-31	The overall prevalence of liver disease in PLWH and the prevalence of hepatitis B, C, and fatty liver

Trial Locations

Locations (1)

the first affiliated hospital of Zhejiang university school of medicine; 🇨🇳 Hangzhou, Zhejiang, China