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

Genexine

Status and phase

Unknown

Phase 1

Conditions

HIV Infections

Treatments

Genetic: GX-12

Drug: HAART

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00517569

GX-12_HIV_I

Details and patient eligibility

About

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

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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