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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Epimmune.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00532974
First Posted: September 21, 2007
Last Update Posted: December 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pharmexa A/S
Pharmexa-Epimmune
Information provided by:
Epimmune
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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:


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 ]

Estimated Enrollment: 32
Study Start Date: October 2006
Estimated Study Completion Date: April 2008
Intervention Details:
    Biological: EP1090
    Low dose
    Biological: EP1090
    High dose
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00532974     History of Changes
Other Study ID Numbers: EP-HIV-1090
First Submitted: September 19, 2007
First Posted: September 21, 2007
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Epimmune:
HIV
Human Immunodeficiency Virus
Vaccines
HIV Vaccines
Peptide
Peptide Vaccines
HIV 1

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs