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Safety of and Immune System Response to an HIV Vaccine (EP-HIV-1090) in HIV Infected Patients



Safety of and Immune System Response to an HIV Vaccine (EP-HIV-1090) in HIV Infected Patients

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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 or not the vaccine can stimulate immune system responses in people who have HIV-1 infection.
Details: Significant data support the hypothesis that HIV-specific cytotoxic T lymphocyte (CTL) responses contribute to the control and potential clearance of the virus. Vaccines designed specifically to induce CTL responses are likely to be well suited for treatment of HIV infection. The conceptual basis of the EP HIV-1090 vaccine is the use of highly defined CTL epitopes as the vaccine immunogen. The vaccine is formulated with a water-soluble polymer that stabilizes and protects the DNA and facilitates uptake by cells. Preclinical studies have shown that the vaccine induces strong CTL responses in animal models. This study will evaluate the safety and tolerability of the vaccine and the immune response to the vaccine in HIV-1-infected individuals who are being treated with highly active antiretroviral therapy (HAART) and have a CD4+ T cell count > or equal to 350 cells and fully suppressed viral replication on stable HAART. Each patient will receive a total of four immunizations to be given at Day 0 and at Weeks 4, 8, and 16. Participants will be randomized to receive either vaccine or placebo. Ten patients will be assigned to each dose group; eight will receive active vaccine and two will receive placebo. The injections will be delivered intramuscularly into the deltoid muscle. In addition to undergoing standard safety exams, patients will have blood drawn for use in evaluating the immunogenicity of the vaccine. The treatment duration will be 16 weeks and patient will be followed for safety and immune responses for an additional 24 weeks after they complete vaccination; the total study is estimated to take 18 months.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/59 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Documented HIV-1 infection - Taking highly active antiretroviral therapy (HAART) for 6 months or longer and on stable HAART for at least 4 weeks - Plasma HIV-1 RNA levels of < 400 copies/ml for at least 6 months prior to study entry - CD4 cell count >= 350 cells/mm3 within 30 days of entry Exclusion Criteria - Immunomodulatory agents - Prior receipt of Experimental HIV vaccines within < 5 years of entry - Hepatitis B surface antigen or hepatitis C virus antibody positive
Total Enrollment: 40

Location and Contact Information:

University of Colorado, Health Science Center
Denver,  Colorado,  80262
United States
 


Additional Information:
Study ID Numbers:  P01 AI48238-03;  IPCP 01
Study Start Date: October 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052182

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