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

NCT00517569 | Unknown Phase 1

• 1 other identifier: GX-12_HIV_I
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

Gene Therapy; GX-12; HIV-1; Interleukin; AIDS; HIV-1 type B infection; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Safety: adverse events and laboratory abnormalities

  36 weeks

Secondary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

GX-12 combined with HAART

Genetic: GX-12; Drug: HAART

Interventions

GX-12 GENETIC

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)

1

HAART DRUG

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.

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead
• Seoul National University Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• KANG-WON CHOE, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MYOUNG-DON OH, M.D., Ph.D.

CONTACT

+82-2-2072-2211; mdohmd@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: August 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 12, 2008

Record last verified: 2008-05

Locations

KR (1)