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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01289106
Eligibility Criteria:
Inclusion Criteria:
* Positive for anti-HIV antibody
* At least 18 years of age
* CD4 \> 200 cell/mm3
* On antiretroviral therapy
* Viral load \< 50 copies/ml
* Negative for any HBV serological marker (HBsAg, Anti-HBs, Anti-HBc)
* No history of previous hepatitis B vaccination
* Anti-HCV negative
* No active opportunistic infection at the time of screening
* Willing to sign informed consent
* Able to follow up
Exclusion Criteria:
* Pregnancy or breast feeding
* History of hypersensitivity to any component of vaccine
* Diagnosis of malignancy and receiving chemotherapy or radiation
* Other immunocompromised conditions not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)
* On Immunosuppressive treatment, immunomodulating treatment or corticosteroid (equal or above 0.5 mg per kg per day of prednisolone)
* Renal failure (creatinine clearance \< 30 mL/min)
* Decompensated cirrhosis (child-pugh C)
* Not able to follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01289106
Study Brief:
Protocol Section:
NCT01289106