Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients
Recruitment status was Recruiting
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- Safety: adverse events and laboratory abnormalities [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
|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)|
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)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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517569
|Contact: MYOUNG-DON OH, M.D., Ph.D.||+email@example.com|
|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|