Thailand HDV Cohort

Recruiting

• Conditions: HDV

• Registration Number: NCT05350865
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Brief 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. 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 Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-28
• Study Start: 2023-01-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3152

Inclusion Criteria

1. Male or female, aged 18 years and older

2. 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

3. Provide signed and dated informed consent form.

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Exclusion Criteria

Non chronic HBV

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
performance of antiHDV commercial kits	1 year	performance of antiHDV commercial kits
prevalence of HDV	1 year	prevalence of HDV among prisoners
proportion of participants with detectable HDV RNA among seropositive anti HDV	1 year	proportion of participants with detectable HDV RNA among seropositive anti HDV in prisoners
HDV subtype	1 year	HDV subtype in prisoners
predictive risk of HDV infection	1 year	predictive risk of HDV infection
prevalence of HDV among HBV/HIV before combination antiretroviral therapy	1 year	prevalence of HDV among HBV/HIV before combination antiretroviral therapy
prevalence of HDV among HBV/HIV after combination antiretroviral therapy	1 year	prevalence of HDV among HBV/HIV after combination antiretroviral therapy

Trial Locations

Locations (4)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand

King memorial Chulalongkorn hospital; 🇹🇭 Bangkok, Thailand

HIV-NAT, Thai Red Cross - AIDS Research Centre; 🇹🇭 Bangkok, Thailand

Taksin Hospital; 🇹🇭 Bangkok, Thailand