Phase I Study for Assessment of Safety of Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients
Sponsor study identifier
interventional
12
1 country
1
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
August 16, 2007
Actual (reported)August 17, 2007
Actual (reported)December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Safety: adverse events and laboratory abnormalities
36 weeks
Primary efficacy endpoint: plasma viral load Secondary efficacy endpoint: CD4 counts and HIV-1 Antigen specific IFN-gamma expressed T-lymphocytes
24, 28, 32 and 36 weeks
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.
Seoul National University Hospital
Seoul, 110-744, South Korea
KANG-WON CHOE, M.D., Ph.D.
Seoul National University Hospital
First Submitted
August 16, 2007
First Posted
August 17, 2007
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)Study of Valproic Acid to Treat HIV Infected Adults
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 12, 2008
Record last verified: 2008-05
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