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

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

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Genetic: GX-12; Drug: HAART

Detailed Description

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
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; GX-12 combined with HAART	Genetic: 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: adverse events and laboratory abnormalities	36 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Collaborators: Seoul National University Hospital
• Investigators: Principal Investigator: KANG-WON CHOE, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: August 16, 2007
• First Submitted That Met QC Criteria: August 16, 2007
• First Posted (Estimate): August 17, 2007

Study Record Updates

• Last Update Posted (Estimate): May 12, 2008
• Last Update Submitted That Met QC Criteria: May 8, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Gene Therapy; HIV-1; AIDS; Treatment Naive; Interleukin; GX-12; HIV-1 type B infection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: GX-12_HIV_I