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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Genetic: GX-12 Drug: HAART | Phase 1 |
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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
GX-12 combined with HAART
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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.
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- Safety: adverse events and laboratory abnormalities [ Time Frame: 36 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: MYOUNG-DON OH, M.D., Ph.D. | +82-2-2072-2211 | mdohmd@snu.ac.kr |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 |
Principal Investigator: | KANG-WON CHOE, M.D., Ph.D. | Seoul National University Hospital |
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 |