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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00517569
• Other study ID #: GX-12_HIV_I
• Status: Recruiting
• Phase: Phase 1
• First received: August 16, 2007
• Last updated: May 8, 2008
• Start date: August 2006
• Est. completion date: December 2009

Study information

• Verified date: May 2008
• Source: Genexine, Inc.
• Contact: MYOUNG-DON OH, M.D., Ph.D.
• Phone: +82-2-2072-2211
• Email: mdohmd[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Genexine, Inc.	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: adverse events and laboratory abnormalities		36 weeks	Yes
Secondary	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	Yes