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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00056758
First received: March 21, 2003
Last updated: August 23, 2007
Last verified: August 2007

March 21, 2003
August 23, 2007
February 2003
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Safety and tolerability of peptide pulsed, autologous, cultured dendritic cells
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Complete list of historical versions of study NCT00056758 on ClinicalTrials.gov Archive Site
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HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
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

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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Biological: Autologous Dendritic Cell HIV Vaccination
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00056758
P01AI43664-04, P01 AI43664-04
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Sharon A. Riddler, MD University of Pittsburgh
National Institute of Allergy and Infectious Diseases (NIAID)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP