HIV Infections Clinical Trial
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
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
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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