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Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00058734
First received: April 11, 2003
Last updated: August 23, 2007
Last verified: August 2007
History of Changes
  Purpose

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 Intervention Phase
HIV Infections
 Biological: Dendritic Cells Pulsed with HIV antigens
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immune Responses to Antigen-Bearing Dendritic Cells in HIV-Infected Individuals

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Enrollment: 5
Study Start Date: November 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058734

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

Publications:

ClinicalTrials.gov Identifier: NCT00058734     History of Changes
Other Study ID Numbers: R01AI44628, R01 AI44628
Study First Received: April 11, 2003
Last Updated: August 23, 2007
Health Authority: United States: Food and Drug Administration

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:
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 May 19, 2013