Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Infected Patients
A Single Center Phase I Safety and Immunogenicity Study of Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) for Immunotherapy of HIV-1 Infected Individuals Receiving Highly Active Antiretroviral Therapy (HAART)
2 other identifiers
interventional
40
1 country
1
Brief Summary
HIV-1-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses to HIV. The DNA-based vaccine in this study is designed to boost the immune system's responses against many HIV-1 proteins. The main purposes of this study are to test the safety of this HIV vaccine (EP HIV-1090) and to test whether the vaccine can stimulate immune system responses in people who have HIV-1 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 24, 2003
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedOctober 23, 2007
September 1, 2007
January 24, 2003
October 22, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and efficacy of four intramuscular doses of EP HIV-1090 to HIV infected participants using highly active antiretroviral therapy (HAART), who have a viral load less than 400
Throughout study
Secondary Outcomes (3)
Peripheral blood CD8 T-cell (CTL) responses to vaccine, compared to placebo
Throughout study
CD4 T-cell count and viral load in patients continuing HAART following vaccination or receipt of placebo
Throughout study
Clinical signs and symptoms and development of AIDS-defining clinical events following vaccination or receipt of placebo in participants who remain on HAART
Throughout study
Study Arms (1)
1
EXPERIMENTALImmunization on Day 0 and Weeks 4, 8, and 16
Interventions
Eligibility Criteria
You may qualify if:
- Documented HIV-1 infection
- Taking HAART for 6 months or longer and on stable HAART for at least 4 weeks
- Plasma HIV-1 viral load of less than 400 copies/ml for at least 6 months prior to study entry
- CD4 count of 350 cells/mm3 or more within 30 days of entry
You may not qualify if:
- Immunomodulatory agents
- Prior receipt of experimental HIV vaccines in the 5 years prior to study entry
- Hepatitis B surface antigen or hepatitis C virus antibody positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado, Health Science Center
Denver, Colorado, 80262, United States
Related Publications (1)
Wilson CC, McKinney D, Anders M, MaWhinney S, Forster J, Crimi C, Southwood S, Sette A, Chesnut R, Newman MJ, Livingston BD. Development of a DNA vaccine designed to induce cytotoxic T lymphocyte responses to multiple conserved epitopes in HIV-1. J Immunol. 2003 Nov 15;171(10):5611-23. doi: 10.4049/jimmunol.171.10.5611.
PMID: 14607970BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Constance Benson, MD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
January 24, 2003
First Posted
January 27, 2003
Study Start
October 1, 2002
Last Updated
October 23, 2007
Record last verified: 2007-09