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)

Epimmune32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV Infections

Interventions

EP1090BIOLOGICAL

Low dose

EP1090BIOLOGICAL

High dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

AIDS Research Alliance

West Hollywood, California, United States

University of Colorado Health Sciences Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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