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

The recruitment status of this study is unknown because the information has not been verified recently.
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

August 16, 2007
May 8, 2008
August 2006
December 2009   (final data collection date for primary outcome measure)
Safety: adverse events and laboratory abnormalities [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
Safety: adverse events and laboratory abnormalities [ Time Frame: 36 weeks ]
Complete list of historical versions of study NCT00517569 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients
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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • 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.
Experimental: 1
GX-12 combined with HAART
Interventions:
  • Genetic: GX-12
  • Drug: HAART
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact: MYOUNG-DON OH, M.D., Ph.D. +82-2-2072-2211 mdohmd@snu.ac.kr
Korea, Republic of
 
NCT00517569
GX-12_HIV_I
No
Prof. Kang-Won Choe / Principal Investigator, Seoul National University Hospital
Genexine, Inc.
Seoul National University Hospital
Principal Investigator: KANG-WON CHOE, M.D., Ph.D. Seoul National University Hospital
Genexine, Inc.
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP