HIV InfectionsNCT03702998
Hepatocellular Carcinoma in HIV-infected Individuals in Asian Population
An observational study of HIV Infections and Hepatitis B, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, Hepatitis B, Hepatitis C
- How many people
- 3,900 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2018to 16 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV-infected individuals with and without HBV/HCV co-infection, and HBV/HCV mono-infected individuals in Hong Kong
Who may be able to join
- 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
- 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
Who cannot join
- -nil
- HBV/HCV mono-infected individuals:
- nil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Mortality of Hepatocellular Carcinoma in HIV-infected Individuals in an Asian Population
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.
Read the 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:
- To determine the burden of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population
- To compare the incidence of HCC between HIV-infected individuals with HBV/HCV co-infection and HIV-uninfected individuals with HBV or HCV-monoinfection
- 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:
3.1 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
- Conditions
- HIV Infections, Hepatitis B, Hepatitis C, Hepatocellular Carcinoma
- Medical subject headings
- HIV Infections, Hepatitis B, Hepatitis C, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: From the time of diagnosis up to 20 years of follow up.
Secondary outcomes (1)
Mortality due to HCC or liver-related conditions
- 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.
Measured: From the time of diagnosis up to 20 years of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Dec 2018
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lui, Chinese University of Hong Kong
- Investigators
- Grace Lui, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702998
- Sponsor's protocol ID
- HCC_HIV protocol_V3_26042017
- Status last verified
- Aug 2023
- First submitted
- 9 Jul 2018
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Mortality of Hepatocellular Carcinoma in HIV-infected Individuals in an Asian Population
- ClinicalTrials.gov ID
- NCT03702998
- Acronym / sponsor ID
- HCC_HIV protocol_V3_26042017
- Conditions
- HIV Infections, Hepatitis B, Hepatitis C, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,900 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To determine the burden of HCC among HIV-infected individuals with and without HBV/HCV co-infection in an Asian population
- To compare the incidence of HCC between HIV-infected individuals with HBV/HCV co-infection and HIV-uninfected individuals with HBV or HCV-monoinfection
- 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:
3.1 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-infected individuals with and without HBV/HCV co-infection, and HBV/HCV mono-infected individuals in Hong Kong
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- -nil
- HBV/HCV mono-infected individuals:
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)).
1 secondary outcome
Mortality due to HCC or liver-related conditions
Time frame: From the time of diagnosis up to 20 years of follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Lui principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis B, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HCC (time frame: From the time of diagnosis up to 20 years of follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.