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Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

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: NCT00058734
Recruitment Status : Completed
First Posted : April 14, 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:
The aim of this trial is to find out if immune responses to HIV can be boosted in individuals who start medicines soon after being infected. If immune responses can be boosted to the virus, this may allow the body to control HIV without the need for medications. This study is designed to test a new strategy for boosting immune responses to HIV and to evaluate if these responses allow people to have control of HIV without medicines.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: Dendritic Cells Pulsed with HIV antigens Phase 1

Detailed Description:

The novel strategy used in this trial is to mix a peptide vaccine with dendritic cells from individuals. The dendritic cells are normal cells in the blood that boost immune responses. In HIV uninfected people, dendritic cells have been found to strongly activate the types of immune responses that may be important in controlling HIV.

HIV infected and HIV uninfected individuals in this study will receive one shot of dendritic cells alone followed by three monthly shots of dendritic cells plus vaccine. We will monitor the immune responses to the peptide vaccine during this time period. After completing the vaccinations, HIV infected patients will stop their HIV medications and their immune status (CD4 count) and viral load will be monitored closely over 12 weeks.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immune Responses to Antigen-Bearing Dendritic Cells in HIV-Infected Individuals
Study Start Date : November 2000

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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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Both HIV infected and HIV uninfected individuals are eligible for this study.

  • CD4 cell count of 400 cells/mm3 or greater at study entry
  • If HIV infected, initiated anti-HIV medicines within 120 days of infection
  • If HIV infected, HIV viral load < 50 copies/ml for at least 3 months prior to study entry
  • Current medication regimen for at least 3 months prior to study entry
  • A particular blood type (HLA-A*0201)
  • Acceptable methods of contraception

Exclusion Criteria:

  • Received investigational drug or vaccine within 30 days prior to study entry
  • On other immune-based therapy (e.g., interleukin-2, alpha interferon, immunoglobulin, thalidomide) within 30 days prior to study entry
  • Megesterol acetate within 30 days prior to study entry
  • Immunization within 4 weeks of study entry
  • If hepatitis B virus (HBV) uninfected and at high risk for HBV infection, the patient will not be eligible until he or she has completed an HBV vaccine series.
  • Unstable or severe medical condition, including active opportunistic infection requiring treatment
  • History of Hashimoto's thyroiditis
  • Cancer requiring chemotherapy within 6 months prior to study entry
  • History of radiation therapy to axillary lymph nodes
  • Significant laboratory abnormalities at study entry
  • Pregnant or breastfeeding
  • History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, scleroderma, mixed connective tissue disorder)
  • Allergy to gentamicin, tobramycin, streptomycin, or amikacin
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): NCT00058734


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Nina Bhardwaj, MD, PhD New York University
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00058734    
Other Study ID Numbers: R01AI044628 ( U.S. NIH Grant/Contract )
R01AI044628 ( U.S. NIH Grant/Contract )
First Posted: April 14, 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):
Dendritic Cell
Immunotherapy
Acute HIV
Human Immunodeficiency Virus
 AIDS
HIV Therapeutic Vaccine
Treatment Experienced
Treatment Interruption
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
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases