Liver Diseases in PLWH

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446156
• Other study ID #: ZJHIVER
• Status: Recruiting
• Start date: May 26, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2020
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Biao Zhu, PhD.
• Phone: +86 13906535457
• Email: zhubiao1207[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV/AIDS
• Liver Diseases

Locations

Country	Name	City	State
China	the first affiliated hospital of Zhejiang university school of medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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