HDVNCT05350865
Thailand HDV Cohort
An observational study of HDV, run by The HIV Netherlands Australia Thailand Research Collaboration at 4 sites in Thailand.
Trial summary
There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HDV
- How many people
- 3,296 participants
- Where
- 4 sitesThailand
- Study dates
- 30 Jan 2023to 1 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronically-infected with HBV, as defined by: Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result
Who may be able to join
- Male or female, aged 18 years and older
- Chronically-infected with HBV, as defined by:
- Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result
- Provide signed and dated informed consent form.
Who cannot join
- Non chronic HBV
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
HIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, Bangkok, 10330
King memorial Chulalongkorn hospital
Bangkok, Bangkok, 10330
Siriraj Hospital, Mahidol University
Bangkok, Bangkok
Taksin Hospital
Bangkok, Bangkok
About this study
Official title: Prevalence, Risk Factor and Clinical Significance of Hepatitis D Virus Infection Among Targeted High Risk Population in Thailand: Nationwide Survey 2022-2024
There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. Therefore, this study plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. Findinds from this study will provide the scientific community to understand how important HDV is among HBV patients, this could be used to develop strategies for HDV screening and treatment
Read the detailed description
The prevalence of HDV remains ill-defined, mainly for lack of appropriate testing and screening. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. This data will inform the guideline whether HDV screening among HBV/HIV is required. This study has plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. This Nationwide survey of HDV is collaboration between Thai liver society, Thai AIDS society, Thai Red Cross AIDS research centre, Faculty of Medicine Chulalongkorn University, and AIDS TB and STI Control Division, Department of Disease control, MOPH Thailand. All findings will be shared and discussed to develop the National guideline for screening, treatment and care.
- Conditions
- HDV
- Keywords
- HBV, HDV, cirrhosis, Thailand
- Medical subject headings
- Fibrosis
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 |
|---|---|---|
| HDV cohort | Chronic Hepatitis B (HBsAg+) with cirrhosis (APRI >1.5, FIB-4 > 3.25, Fibroscan > 12.5, imaging), PWID with HBV, HIV/HBV, HBV/HCV, aged 18 years and older |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of HDV
prevalence of HDV in patients with cirrhosis
Measured: 1 year
prevalence of HDV
prevalence of HDV in patients with non cirrhosis
Measured: 1 year
prevalence of HDV
prevalence of HDV in HIV positive people with injecting drug use
Measured: 1 year
prevalence of HDV
prevalence of HDV in HIV negative people with injecting drug use
Measured: 1 year
prevalence of HDV
prevalence of HDV among HBV/HIV men who have sex with men
Measured: 1 year
prevalence of HDV
prevalence of HDV among HBV/HIV cisgender male patients
Measured: 1 year
prevalence of HDV
prevalence of HDV among prisoners
Measured: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV
proportion of participants with detectable HDV RNA among seropositive anti HDV with cirrhosis
Measured: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV
proportion of participants with detectable HDV RNA among seropositive anti HDV without cirrhosis
Measured: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV
proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID with HIV
Measured: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV
proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID without HIV
Measured: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV
proportion of participants with detectable HDV RNA among seropositive anti HDV with HIV/HBV MSM
Measured: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV
proportion of participants with detectable HDV RNA among seropositive anti HDV in HIV/HBV cisgender males
Measured: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV
proportion of participants with detectable HDV RNA among seropositive anti HDV in prisoners
Measured: 1 year
predictive risk of HDV infection
predictive risk of HDV infection
Measured: 1 year
HDV subtype
HDV subtype among people with cirrhosis
Measured: 1 year
HDV subtype
HDV subtype among people without cirrhosis
Measured: 1 year
HDV subtype
HDV subtype in PWID with HIV
Measured: 1 year
HDV subtype
HDV subtype in PWID without HIV
Measured: 1 year
HDV subtype
HDV subtype in HBV/HIV MSM
Measured: 1 year
HDV subtype
HDV subtype in HBV/HIV cisgender males
Measured: 1 year
HDV subtype
HDV subtype in prisoners
Measured: 1 year
performance of antiHDV commercial kits
performance of antiHDV commercial kits
Measured: 1 year
prevalence of HDV among HBV/HIV before combination antiretroviral therapy
prevalence of HDV among HBV/HIV before combination antiretroviral therapy
Measured: 1 year
prevalence of HDV among HBV/HIV after combination antiretroviral therapy
prevalence of HDV among HBV/HIV after combination antiretroviral therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start30 Jan 2023
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDVStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 3,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital, Thai Red Cross AIDS Research Centre, Siriraj Hospital, Taksin Hospital, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Anchalee Avihingsanon, MD, PhD, Principal investigator, Thai Red Cross AIDS Research CentrePisit Tangkijvanich, MD, Principal investigator, Biochemistry, Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350865
- Sponsor's protocol ID
- HIV-NAT 304
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Risk Factor and Clinical Significance of Hepatitis D Virus Infection Among Targeted High Risk Population in Thailand: Nationwide Survey 2022-2024
- ClinicalTrials.gov ID
- NCT05350865
- Acronym / sponsor ID
- HIV-NAT 304
- Conditions
- HDV
- Keywords
- HBV, HDV, cirrhosis, Thailand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,296 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital, Thai Red Cross AIDS Research Centre, Siriraj Hospital, Taksin Hospital, Gilead Sciences
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 28 Apr 2022 (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.
There is very limited data of HDV in Thailand. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. Therefore, this study plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. Findinds from this study will provide the scientific community to understand how important HDV is among HBV patients, this could be used to develop strategies for HDV screening and treatment
Detailed description
The prevalence of HDV remains ill-defined, mainly for lack of appropriate testing and screening. As both HDV and HIV can accelerate the HBV course and increased the risk of death, particularly, among those with low CD4 cells/count, therefore, HDV burden in this special population is unmet need. This data will inform the guideline whether HDV screening among HBV/HIV is required. This study has plans to perform a nationwide survey of the prevalence and predictor of HDV among people uses drugs (PWID) with and without HIV, HBV/HIV (MSM vs non MSM), HBV related cirrhosis. This Nationwide survey of HDV is collaboration between Thai liver society, Thai AIDS society, Thai Red Cross AIDS research centre, Faculty of Medicine Chulalongkorn University, and AIDS TB and STI Control Division, Department of Disease control, MOPH Thailand. All findings will be shared and discussed to develop the National guideline for screening, treatment and care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDV cohort | – | –Chronic Hepatitis B (HBsAg+) with cirrhosis (APRI >1.5, FIB-4 > 3.25, Fibroscan > 12.5, imaging), PWID with HBV, HIV/HBV, HBV/HCV, aged 18 years and older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronically-infected with HBV, as defined by: Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result
Key inclusion criteria (4 listed)
- Male or female, aged 18 years and older
- Chronically-infected with HBV, as defined by:
- Positive Hepatitis B surface antigen HBsAg) or HBV DNA result with a subsequent positive HBsAg or HBV DNA result at least 6 months after first positive result
- Provide signed and dated informed consent form.
Key exclusion criteria (1 listed)
- Non chronic HBV
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
prevalence of HDV
Time frame: 1 year
prevalence of HDV in patients with cirrhosis
prevalence of HDV
Time frame: 1 year
prevalence of HDV in patients with non cirrhosis
prevalence of HDV
Time frame: 1 year
prevalence of HDV in HIV positive people with injecting drug use
prevalence of HDV
Time frame: 1 year
prevalence of HDV in HIV negative people with injecting drug use
prevalence of HDV
Time frame: 1 year
prevalence of HDV among HBV/HIV men who have sex with men
prevalence of HDV
Time frame: 1 year
prevalence of HDV among HBV/HIV cisgender male patients
prevalence of HDV
Time frame: 1 year
prevalence of HDV among prisoners
proportion of participants with detectable HDV RNA among seropositive anti HDV
Time frame: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV with cirrhosis
proportion of participants with detectable HDV RNA among seropositive anti HDV
Time frame: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV without cirrhosis
proportion of participants with detectable HDV RNA among seropositive anti HDV
Time frame: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID with HIV
proportion of participants with detectable HDV RNA among seropositive anti HDV
Time frame: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV in PWID without HIV
proportion of participants with detectable HDV RNA among seropositive anti HDV
Time frame: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV with HIV/HBV MSM
proportion of participants with detectable HDV RNA among seropositive anti HDV
Time frame: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV in HIV/HBV cisgender males
proportion of participants with detectable HDV RNA among seropositive anti HDV
Time frame: 1 year
proportion of participants with detectable HDV RNA among seropositive anti HDV in prisoners
predictive risk of HDV infection
Time frame: 1 year
predictive risk of HDV infection
HDV subtype
Time frame: 1 year
HDV subtype among people with cirrhosis
HDV subtype
Time frame: 1 year
HDV subtype among people without cirrhosis
HDV subtype
Time frame: 1 year
HDV subtype in PWID with HIV
HDV subtype
Time frame: 1 year
HDV subtype in PWID without HIV
HDV subtype
Time frame: 1 year
HDV subtype in HBV/HIV MSM
HDV subtype
Time frame: 1 year
HDV subtype in HBV/HIV cisgender males
HDV subtype
Time frame: 1 year
HDV subtype in prisoners
performance of antiHDV commercial kits
Time frame: 1 year
performance of antiHDV commercial kits
prevalence of HDV among HBV/HIV before combination antiretroviral therapy
Time frame: 1 year
prevalence of HDV among HBV/HIV before combination antiretroviral therapy
prevalence of HDV among HBV/HIV after combination antiretroviral therapy
Time frame: 1 year
prevalence of HDV among HBV/HIV after combination antiretroviral therapy
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 17 Sep 2026.
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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.
Anchalee Avihingsanon, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre
Pisit Tangkijvanich, MD principal investigator
Biochemistry, Faculty of Medicine, Chulalongkorn University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HDV, run by The HIV Netherlands Australia Thailand Research Collaboration at 4 sites in Thailand.
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 4 inclusion and 1 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. 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?
prevalence of HDV (time frame: 1 year). The study lists 25 primary outcomes in all. 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 17 Sep 2026.