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

Sponsor:	Genexine Co., Ltd.
Collaborator:	Seoul National University Hospital
Information provided by:	Genexine Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00517569

Purpose

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

Condition	Intervention	Phase
HIV Infections	Genetic: GX-12 Drug: HAART	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by Genexine Co., Ltd.:

Primary Outcome Measures:

Safety: adverse events and laboratory abnormalities [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Primary efficacy endpoint: plasma viral load Secondary efficacy endpoint: CD4 counts and HIV-1 Antigen specific IFN-gamma expressed T-lymphocytes [ Time Frame: 24, 28, 32 and 36 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental GX-12 combined with HAART	Genetic: GX-12 a mixed plasma DNA (HIV-1 antigen genes and human IL-12 mutant) 4, 8, 16mg, i.m., once every other weeks for 22 weeks (total 12 times) Drug: HAART Highly active antiretroviral therapy; Discontinuation at 24 weeks; NB: The patients should be treated with 2 NRTIs+1 NNRTI or 2 NRTIs + 1 PI, according to the guidelines published by DHHS in the USA.

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517569

Contacts

Contact: MYOUNG-DON OH, M.D., Ph.D.

+82-2-2072-2211

mdohmd@snu.ac.kr

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Genexine Co., Ltd.

Seoul National University Hospital

Investigators

Principal Investigator:

KANG-WON CHOE, M.D., Ph.D.

Seoul National University Hospital

More Information

No publications provided

Responsible Party:	Seoul National University Hospital ( Prof. Kang-Won Choe / Principal Investigator )
Study ID Numbers:	GX-12_HIV_I
Study First Received:	August 16, 2007
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00517569 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Genexine Co., Ltd.:

Gene Therapy
GX-12
HIV-1
Interleukin

AIDS
HIV-1 type B infection
Treatment Naive

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010