Liver Diseases in PLWH

Epidemiological Investigation of HIV-infected Patients Complicated With Liver Disease in Zhejiang Province

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.

Study Overview

• Status: Unknown
• Conditions: Liver Diseases; HIV/AIDS

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Biao Zhu, PhD.; Phone Number: +86 13906535457; Email: zhubiao1207@zju.edu.cn
• Study Contact Backup: Name: Yongzheng Guo, MD.; Phone Number: +86 13645814389; Email: ggyongzheng08@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Yongzheng Guo, MD; Phone Number: +86 13645814389; Email: ggyongzheng08@zju.edu.cn
      • Contact: Biao Zhu, PhD; Phone Number: +86 13906535457; Email: zhubiao1207@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

PLWH crowd in Zhejiang Province

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: ZJHIVER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No