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HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00056758
Recruitment Status : Completed
First Posted : March 24, 2003
Last Update Posted : August 27, 2007
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:
This study will evaluate the safety of and immune responses to a dendritic cell vaccination for HIV-1 infection. The vaccine will be made from a patient's own cells combined with small fragments of HIV-1 (made synthetically in a laboratory). These cells will be administered back to the patient either into a vein (intravenously) or the skin (subcutaneously).

Condition or disease Intervention/treatment Phase
HIV Infections Biological: Autologous Dendritic Cell HIV Vaccination Phase 1

Detailed Description:

Untreated HIV-1 infection is characterized by progressive immune dysfunction and the development of opportunistic infections and AIDS-associated malignancies. Highly active antiretroviral therapy (HAART) has been successful in suppressing HIV replication and restoring partial immune function. However, HIV-specific immunity remains poor, as evidenced by rapid rebound of HIV-1 RNA following HAART withdrawal. Studies of individuals with acute HIV-1 infection, as well as those who are long-term nonprogressors, have suggested that robust HIV-specific immune responses are associated with control of HIV-1 viremia. Dendritic cells (DCs) are potent antigen presenting cells that may increase HIV-specific immune responses. This protocol will evaluate the use of DCs to help control HIV infection.

Patients will be randomized to receive either intravenous or subcutaneous administration of HIV antigen expressing DCs. Each subject will receive two administrations of mature DCs given 3 weeks apart. Subjects will be followed weekly for 8 weeks, then at Weeks 12, 16, 24, 36, and 48. Two doses of DCs will be evaluated (low dose: 1-3 million cells; high dose: 5-10 million cells) for safety and immune system response.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase I Evaluation of Immunization With Highly Conserved HIV-1 Derived Peptides and Influenza Matrix Peptide in HIV-1-Infected Subjects on Highly Active Antiretroviral Therapy (HAART) Using Autologous Dendritic Cells Derived From Adherent Monocytic Precursors
Study Start Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vaccines

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of peptide pulsed, autologous, cultured dendritic cells

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • HIV-1 infection
  • Current CD4 count more than 400/mm3
  • HIV RNA less than 400 copies/ml
  • Stable combination antiretroviral therapy for at least 4 weeks prior to study entry
  • HLA A2.1 (to be tested at screening)

Exclusion criteria

  • Prior HIV vaccine
  • Systemic steroids or immunosuppressive drugs within 30 days of study entry
  • Pregnant or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056758


Locations
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United States, Pennsylvania
University of Pittsburgh, Pitt Treatment Evaluation Unit
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Sharon A. Riddler, MD University of Pittsburgh
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00056758    
Other Study ID Numbers: P01AI043664-04 ( U.S. NIH Grant/Contract )
P01AI043664-04 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2003    Key Record Dates
Last Update Posted: August 27, 2007
Last Verified: August 2007
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-1
HAART
Therapeutic immunization
HIV Therapeutic Vaccine
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
 RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs