NCT03702998

Brief Summary

This is a retrospective study, all HIV-infected individuals followed up at the three designated HIV clinics in Hong Kong with and without HBV and/or HCV co-infection will be included in the analysis. The incidence and mortality of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population will be determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 9, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

4.1 years

First QC Date

July 9, 2018

Last Update Submit

August 28, 2023

Conditions

HIV InfectionsHepatitis BHepatitis CHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Incidence of HCC

    Diagnoses that will be included in the primary outcome include: ICD9 coded diagnoses of cancer of liver (155); malignant neoplasm of liver, primary (155.0); cancer of liver, primary (155.0(0)), primary carcinoma of liver (155.0(1)); hepatocellular carcinoma (155.0(2)); malignant neoplasm of liver, not specified (155.2); cancer of liver (155.2(0)); carcinoma of liver (155.2(1)).

    From the time of diagnosis up to 20 years of follow up.

Secondary Outcomes (1)

  • Mortality due to HCC or liver-related conditions

    From the time of diagnosis up to 20 years of follow up.

Study Arms (2)

HIV-infected individuals +/- HBV/ HCV

1 All HIV-infected individuals followed up in all public HIV clinics with and without HBV and/or HCV co-infection will be included in the analysis. 1.1 Inclusion criteria for HIV-infected individuals with and without HBV or HCV co-infection: 1.1.1 Positive HIV antibody 1.1.2 At least one visit in one of the HIV clinics 1.1.3 Subjects with positive HBsAg and/or anti-HBc will be regarded as having HBV co-infection 1.1.4 Subjects with positive HCV antibody will be regarded as having HCV co-infection

HBV/HCV mono-infected individuals

2 All HBV and/or HCV-infected individuals followed up in public hospitals will be identified from the Hospital Authority electronic database. 2.1 Inclusion criteria for HBV/HCV mono-infected individuals 2.1.1 Documented diagnosis of hepatitis B or hepatitis C infection, or 2.1.2 Positive HBsAg and/or anti-HBc, or 2.1.3 Positive HCV antibody, and 2.1.4 Negative HIV antibody result, or no record of HIV diagnosis or anti-retroviral therapy prescription

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV-infected individuals with and without HBV/HCV co-infection, and HBV/HCV mono-infected individuals in Hong Kong

You may qualify if:

  • Positive HIV antibody
  • At least one visit in one of the HIV clinics
  • Subjects with positive HBsAg and/or anti-HBc will be regarded as having HBV co-infection
  • Subjects with positive HCV antibody will be regarded as having HCV co-infection

You may not qualify if:

  • nil
  • HBV/HCV mono-infected individuals:
  • Documented diagnosis of hepatitis B or hepatitis C infection, or
  • Positive HBsAg and/or anti-HBc, or
  • Positive HCV antibody, and
  • Negative HIV antibody result, or no record of HIV diagnosis or anti-retroviral therapy prescription
  • \- nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis BHepatitis CCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae InfectionsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Study Officials

  • Grace Lui

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 9, 2018

First Posted

October 11, 2018

Study Start

December 1, 2018

Primary Completion

January 16, 2023

Study Completion

January 16, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

HK(1)