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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)

NCT ID: NCT00532974

Last Updated: 2007-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Keywords

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HIV Human Immunodeficiency Virus Vaccines HIV Vaccines Peptide Peptide Vaccines HIV 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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EP1090

Low dose

Intervention Type BIOLOGICAL

EP1090

High dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmexa A/S

INDUSTRY

Sponsor Role collaborator

Pharmexa-Epimmune

UNKNOWN

Sponsor Role collaborator

Epimmune

INDUSTRY

Sponsor Role lead

Locations

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AIDS Research Alliance

West Hollywood, California, United States

Site Status

University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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EP-HIV-1090

Identifier Type: -

Identifier Source: org_study_id