skip to content

Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified May 2008

Sponsor
Genexine, Inc.

Collaborator
Seoul National University Hospital

Information provided by (Responsible Party)
Genexine, Inc.
ClinicalTrials.gov Identifier
NCT00517569

First received: August 16, 2007
Last updated: May 8, 2008
Last Verified: May 2008
History of Changes
Purpose

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: 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

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

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
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

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

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

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.