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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2008 by Genexine, Inc..
Recruitment status was: Recruiting

Sponsor:

Collaborator:

Seoul National University Hospital

Information provided by:

Genexine, Inc.

ClinicalTrials.gov Identifier:

NCT00517569

First received: August 16, 2007

Last updated: May 8, 2008

Last verified: May 2008

History of Changes

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 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Genes and Gene Therapy HIV/AIDS

U.S. FDA Resources

Further study details as provided by Genexine, Inc.:

Primary Outcome Measures:

Safety: adverse events and laboratory abnormalities [ Time Frame: 36 weeks ]

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 ]


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
Experimental: 1 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 (Adult)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.

Seoul National University Hospital

Investigators


Principal Investigator:	KANG-WON CHOE, M.D., Ph.D.	Seoul National University Hospital

More Information


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

Keywords provided by Genexine, Inc.:


Gene Therapy GX-12 HIV-1 Interleukin	AIDS HIV-1 type B infection Treatment Naive

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on June 22, 2017

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