A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART) - Full Text View

A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART) (EP1090)

This study is ongoing, but not recruiting participants.

First Received: September 19, 2007 Last Updated: December 19, 2007 History of Changes

Sponsor:	Epimmune
Collaborators:	Pharmexa A/S Pharmexa-Epimmune
Information provided by:	Epimmune
ClinicalTrials.gov Identifier:	NCT00532974

Purpose

The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.

Condition	Intervention	Phase
HIV Infections	Biological: EP1090	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by Epimmune:

Primary Outcome Measures:

Safety and Immunogenicity: defined as the effect of the vaccine on peripheral blood CD8 CTL responses, CD4 T cell counts, plasma HIV-1 RNA levels and clinical signs and symptoms. [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2008

Intervention Details:

Low dose

High dose

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 Infection
CD4 Tcell count >350
HIV-1 RNA levels to <400 copies
Negative HbsAg and anti-HCV antibody

Exclusion Criteria:

Recent receipt of experimental HIV-1 vaccines
Recent use of immunomodulatory agents
Hypersensitivity or serious reactions to study vaccine components
Active opportunistic infections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532974

Locations

United States, California
AIDS Research Alliance
West Hollywood, California, United States, 90069
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262

Sponsors and Collaborators

Epimmune

Pharmexa A/S

Pharmexa-Epimmune

More Information

No publications provided

Study ID Numbers:	EP-HIV-1090
Study First Received:	September 19, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00532974 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Epimmune:

HIV
Human Immunodeficiency Virus
Vaccines
HIV Vaccines

Peptide
Peptide Vaccines
HIV 1

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010