NCT04446156

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 22, 2020

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeLiver Diseases

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDigestive System Diseases

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

Locations