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

8. maj 2008 opdateret af: Genexine, Inc.

Phase I Study for Assessment of Safety of Gene Therapy With GX-12 in Combination With HAART for the HIV-1 Infected Patients

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

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

12

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 110-744
        • Rekruttering
        • Seoul National University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
GX-12 combined with HAART
Genetisk: 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)
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Safety: adverse events and laboratory abnormalities
Tidsramme: 36 weeks
36 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Primary efficacy endpoint: plasma viral load Secondary efficacy endpoint: CD4 counts and HIV-1 Antigen specific IFN-gamma expressed T-lymphocytes
Tidsramme: 24, 28, 32 and 36 weeks
24, 28, 32 and 36 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Genexine, Inc.

Samarbejdspartnere

Seoul National University Hospital

Efterforskere

  • Ledende efterforsker: KANG-WON CHOE, M.D., Ph.D., Seoul National University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2006

Primær færdiggørelse (Forventet)

1. december 2009

Studieafslutning (Forventet)

1. december 2009

Datoer for studieregistrering

Først indsendt

16. august 2007

Først indsendt, der opfyldte QC-kriterier

16. august 2007

Først opslået (Skøn)

17. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. maj 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2008

Sidst verificeret

1. maj 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GX-12_HIV_I

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

Kliniske forsøg med GX-12

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