Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517569
Status:
UNKNOWN
Last Update Posted:
2008-05-12
First Post:
2007-08-16
Brief Title:
Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients
Sponsor:
Genexine Inc
Organization:
Genexine Inc
Study Overview
Official Title:
Phase I Study for Assessment of Safety of Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Currently management of HIV infection and AIDS is mainly done by antiviral chemotherapy which inhibits reverse transcriptase or proteolytic enzyme The HAART highly active antiretroviral therapy has indeed succeeded extraordinary in decrease of the mortality and in increase of the life expediency of AIDS patients However there have been some significant limitations of them for example treatment fatigues the side effects the emergency of resistant high medical costs etc
Recently there has been a number of bioresearch for immunotherapy to overcome these limitations of current medications GX-12 is a genetic using a naked DNA with human IL-12 mutant as immune adjuvant GX-12 is designed to vaccinate the individuals with HIV antigens which is to result in enhancing the HIV specific immunity and to expand broadly the immune responses nonspecifically
In this study the safety and efficacy of GX-12 will be investigated
Recently there has been a number of bioresearch for immunotherapy to overcome these limitations of current medications GX-12 is a genetic using a naked DNA with human IL-12 mutant as immune adjuvant GX-12 is designed to vaccinate the individuals with HIV antigens which is to result in enhancing the HIV specific immunity and to expand broadly the immune responses nonspecifically
In this study the safety and efficacy of GX-12 will be investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None