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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00052182
First received: January 24, 2003
Last updated: October 22, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: EP HIV-1090
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 [ Time Frame: Throughout study ]

Secondary Outcome Measures:
  • Peripheral blood CD8 T-cell (CTL) responses to vaccine, compared to placebo [ Time Frame: Throughout study ]
  • CD4 T-cell count and viral load in patients continuing HAART following vaccination or receipt of placebo [ Time Frame: 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 [ Time Frame: Throughout study ]

Enrollment: 40
Study Start Date: October 2002
Arms Assigned Interventions
Experimental: 1
Immunization on Day 0 and Weeks 4, 8, and 16
Biological: EP HIV-1090

Detailed Description:

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 count of 350 cells/mm3 or more 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 randomly assigned 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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052182

Locations
United States, Colorado
University of Colorado, Health Science Center
Denver, Colorado, United States, 80262
Sponsors and Collaborators
Investigators
Study Chair: Constance Benson, MD University of California, San Diego
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00052182     History of Changes
Other Study ID Numbers: P01 AI48238-03, IPCP 01
Study First Received: January 24, 2003
Last Updated: October 22, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Therapeutic Vaccine
CTL Epitope
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 26, 2014