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 because the information has not been verified recently.
Verified December 2007 by Epimmune.
Recruitment status was  Active, not recruiting
Pharmexa A/S
Information provided by:
ClinicalTrials.gov 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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 ClinicalTrials.gov 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

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

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

ClinicalTrials.gov processed this record on May 26, 2016