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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
Pharmexa A/S
Information provided by:
Epimmune Identifier:
First received: September 19, 2007
Last updated: December 19, 2007
Last verified: December 2007
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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00532974

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
Pharmexa A/S
  More Information Identifier: NCT00532974     History of Changes
Other Study ID Numbers: EP-HIV-1090
Study First Received: September 19, 2007
Last Updated: December 19, 2007

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

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
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017