Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT03219203
Eligibility Criteria:
Inclusion Criteria:
* Document of HIV infection
* Thai nationality
* Age ≥18 years old
* Born after 1 January 1992
* Has been taking antiretroviral drugs for HIV treatment
* CD4 ≥200 cell/mm3 and VL \<50 copies/mL for at least 6 months before enrollment
* Negative for any HBV and HCV serological markers
* Willing to sign informed consent
* Able to follow up
Exclusion Criteria:
* Active opportunistic infection
* Pregnancy or breast feeding
* History of previous hepatitis B vaccine booster
* History of hypersensitivity to any component of vaccine
* Malignancy which received chemotherapy or radiation
* Immunocompromised condition such as solid-organ transplantation, chemotherapy in the last 6 months
* On Immunosuppressive treatment, immunomodulating treatment or general corticotherapy (equal or above 0.5 mg per kg per day )
* Renal failure (creatinine clearance \<30 mL/min)
* Transaminitis in the past 3 months (≥ 5 UNL)
* Decompensated cirrhosis (child-Pugh class C)
* Unable or not willing to return for follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT03219203
Study Brief:
Protocol Section:
NCT03219203