Clinical Trials

MainTitle

Hepatocellular Carcinoma in HIV-infected Individuals in Asian Population

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2019 by Grace Lui, Chinese University of Hong Kong

Sponsor
Chinese University of Hong Kong


Information provided by (Responsible Party)
Grace Lui, Chinese University of Hong Kong

ClinicalTrials.gov Identifier
NCT03702998

First received: July 9, 2018
Last updated: January 3, 2019
Last Verified: January 2019
History of Changes
Purpose

Purpose

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.

Condition
HIV Infections
Hepatitis B
Hepatitis C
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence and Mortality of Hepatocellular Carcinoma in HIV-infected Individuals in an Asian Population

Further study details as provided by Grace Lui, Chinese University of Hong Kong:

Primary Outcome Measures

  • Incidence of HCC [ Time Frame: From the time of diagnosis up to 20 years of follow up. ]
    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)).
Secondary Outcome Measures:
  • Mortality due to HCC or liver-related conditions [ Time Frame: From the time of diagnosis up to 20 years of follow up. ]
    Cause of death as documented in death certificate that included HCC as primary or secondary causes of death will be regarded as death due to HCC. Cause of death due to liver-related conditions will include the following conditions: hepatitis B, hepatitis C, viral hepatitis, hepatic failure, chronic hepatitis, cirrhosis of liver, liver failure, chronic liver disease, or hepatorenal syndrome.

Estimated Enrollment: 3900
Study Start Date: December 1, 2018
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Arms
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

Detailed Description:

The incidence of hepatocellular carcinoma (HCC) is increasing over time among the HIV-infected population, and is an increasingly important cause of morbidity and mortality in HIV-infected individuals. Despite effective treatment for HBV and HCV infections, HCC is still reported in treated HIV-infected individuals with HBV/HCV co-infections. Currently, data on the risk and outcomes of HCC in HIV infected populations in Asia is lacking. This study aims to evaluate the incidence of HCC in HIV-infected individuals with and without HBV/HCV co-infection, and HBV/HCV mono-infected individuals in Hong Kong.
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 burden of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population will be determined by comparing their incidence and mortality.
Objectives:

  1. To determine the burden of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population
  2. To compare the incidence of HCC between HIV-infected individuals with HBV/HCV co-infection and HIV-uninfected individuals with HBV or HCV-monoinfection
  3. To compare the mortality rate of HCC between HIV-infected individuals with HBV/HCV co- infection and HIV-uninfected individuals with HBV or HCV-monoinfection.

Study procedures
  • The electronic databases and medical records of all three HIV centres, and Clinical Data Analysis and Reporting System (CDARS) will be reviewed for data extraction for HIV-infected individuals.
  • The medical records and electronic database of Hospital Authority, Clinical Data Analysis and Reporting System (CDARS), will be reviewed for data extraction for HBV and HCV-infected individuals without HIV infection.
  • The following demographic and clinical data will be retrieved:
  • 1 Date of birth, gender, ethnicity 3.2 Date of diagnosis of HIV infection 3.3 Route of transmission of HIV infection 3.4 Other concomitant chronic liver diseases (including alcoholic liver disease, fatty liver, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis etc) 3.5 Presence of cirrhosis and cirrhotic complications (including ascites, esophageal varices, encephalopathy, hepatorenal syndrome, hepatic coma) 3.6 Other comorbidities, including diabetes mellitus, drug-induced hepatitis, alcoholism 3.7 History of AIDS-defining illness 3.8 Nadir CD4 count, latest CD4 count 3.9 Latest HIV viral load 3.10 Bilirubin, ALT, ALP, total protein, albumin, platelet count, prothrombin time 3.11 HBeAg, anti-HBe, HBV DNA, HCV RNA 3.12 Antiviral therapy for HIV, HBV and HCV, including date of initiation and cessation, and name of drugs prescribed 3.13 Date of last follow-up 3.14 Date of diagnosis of liver cancer 3.15 Treatment of liver cancer (surgical, locoregional, chemotherapy, others) 3.16 Date and cause of death

    Eligibility

    Eligibility

    Ages Eligible for Study: Child, Adult, Senior  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  
    Sampling Method: Probability Sample  

    Study Population

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

    Criteria

    1. HIV-infected individuals with and without HBV or HCV co-infection:


  • Inclusion criteria:
    • 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

    • Exclusion criteria:
    • nil
  • HBV/HCV mono-infected individuals:

  • Inclusion criteria:
    • 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

    • Exclusion criteria:
    • nil

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03702998

    Contacts

    Contact:   Catherine Cheung +852 22528755 catherinecheung@cuhk.edu.hk
    Contact:   Rity Wong +852 35053376 ritywong@cuhk.edu.hk

    Locations

    Hong Kong
    Prince of Wales Hospital Recruiting
    Sha Tin, Hong Kong
    Contact:    35056000

    Sponsors and Collaborators

    Chinese University of Hong Kong

    Investigators

    Principal Investigator: Grace Lui Chinese University of Hong Kong
    More Information

    More Information


    Responsible Party: Grace Lui, Assistant Professor, Chinese University of Hong Kong  
    ClinicalTrials.gov Identifier: NCT03702998   History of Changes  
    Other Study ID Numbers: HCC_HIV protocol_V3_26042017  
    Study First Received: July 9, 2018  
    Last Updated: January 3, 2019  

    Studies a U.S. FDA-regulated Drug Product: No  
    Studies a U.S. FDA-regulated Device Product: No  

    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis B
    Carcinoma
    Carcinoma, Hepatocellular
    Hepatitis

    ClinicalTrials.gov processed this data on June 02, 2020
    This information is provided by ClinicalTrials.gov.