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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)

NCT00532974 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2007-12-24

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

EP1090

Low dose

BIOLOGICAL

EP1090

High dose

Sponsors & Collaborators

  • Pharmexa A/S

    collaborator INDUSTRY

  • Pharmexa-Epimmune

    collaborator UNKNOWN

  • Epimmune

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00532974 on ClinicalTrials.gov