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
|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)|
|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|
GX-12 combined with HAART
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)
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.
- 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 ]
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.||+firstname.lastname@example.org|
|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|