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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00517569
Eligibility Criteria:
Inclusion Criteria:
* Aged between 18 and 50 years
* HIV-1 type B infected but asymptomatic patient
* Patient who has received HAART less than 6 months according to the standard management guidelines and reached to aviremia
* Patient with appropriate immunity (i.e., CD4 counts\>=400cells/ul and SI\>3 by CD4+ T-cell proliferation in vitro assay)
* Patient with negative HBV and HCV
* Woman who is not childbearing or who has used any contraceptive at least for 3 months before study entry
* Patients given a written consent
Exclusion Criteria:
* Patient who has received other investigational drug or who participated into other study within 30 days before this study
* Patient who had an experience of hypersensitivity to same drug (for example: a plasmid DNA, etc)
* Patient who has received an immunosuppressant
* Patient who has received other HIV vaccine
* Patient who has received other interleukin(s)
* Patient who experienced an opportunistic infection defined as AIDS before this study
* Patient with any severe recurrent diarrhea or vomiting
* Patient with clinically significant acute or chronic liver dysfunction, kidney dysfunction, hematological disorder, endocrine disorder, immune disorder, heart disease, infection, etc.
* Patient with malignant tumor(s)
* Patient with alcohol or drug abuse
* Patient of potential harm due to drug interactions by HAART
* Woman of pregnancy (positive pregnancy test) or beast feeding
* Patient who is not appropriate at investigator's discretion, not specified in above
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00517569
Study Brief:
Protocol Section:
NCT00517569