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

Primary Purpose

HIV Infections

Status

Unknown status

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GX-12

HAART

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Gene Therapy, GX-12, HIV-1, Interleukin, AIDS, HIV-1 type B infection, Treatment Naive

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

GX-12 combined with HAART

Outcomes

Primary Outcome Measures

Safety: adverse events and laboratory abnormalities

Secondary Outcome Measures

Primary efficacy endpoint: plasma viral load Secondary efficacy endpoint: CD4 counts and HIV-1 Antigen specific IFN-gamma expressed T-lymphocytes

Full Information

NCT ID

NCT00517569

First Posted

August 16, 2007

Last Updated

May 8, 2008

Sponsor

Genexine, Inc.

Collaborators

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00517569

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

August 2006 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Genexine, Inc.

Collaborators

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

GX-12 combined with HAART

Intervention Type

Genetic

Intervention Name(s)

GX-12

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

HAART

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety: adverse events and laboratory abnormalities

Time Frame

36 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+82-2-2072-2211

mdohmd@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

KANG-WON CHOE, M.D., Ph.D.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Individual Site Status

Recruiting

12. IPD Sharing Statement

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

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