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

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ClinicalTrials.gov Identifier: NCT00517569
Recruitment Status : Unknown
Verified May 2008 by Genexine, Inc..
Recruitment status was:  Recruiting
First Posted : August 17, 2007
Last Update Posted : May 12, 2008
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by:
Genexine, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Genetic: GX-12 Drug: HAART Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety: adverse events and laboratory abnormalities [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: May 12, 2008
Last Verified: May 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