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NCT00532974 Clinical Trial

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)

HIV Infections Clinical Trial

— EP1090  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00532974
Other study ID # EP-HIV-1090
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received September 19, 2007
Last updated December 19, 2007
Start date October 2006
Est. completion date April 2008

Study information
Verified date December 2007
Source Epimmune
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 32
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• EP1090
Low dose
• EP1090
High dose

Locations
Country Name City State
United States University of Colorado Health Sciences Center Denver Colorado
United States AIDS Research Alliance West Hollywood California

Sponsors (3)
Lead Sponsor Collaborator
Epimmune Pharmexa A/S, Pharmexa-Epimmune

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. six months Yes
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