Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients

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