Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments ep1090
Phase phase 1
Sponsor Epimmune
Collaborator Pharmexa A/S
Start date October 2006
End date April 2008
Trial size 32 participants
Trial identifier NCT00532974, EP-HIV-1090

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by Epimmune.