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

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety of GX-12 gene therapy combined with HAART in the HIV-1 infected patients and to investigate the efficacy with the value of plasma viral load and with CD4 counts and HIV-1 specific IFN-gamma expressed T-lymphocytes

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genexine, Inc.
• Collaborator: Seoul National University Hospital

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