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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00058734 |
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 |
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HIV Infections |
Biological: Dendritic Cells Pulsed with HIV antigens |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Immune Responses to Antigen-Bearing Dendritic Cells in HIV-Infected Individuals |
Enrollment: | 5 |
Study Start Date: | November 2000 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Both HIV infected and HIV uninfected individuals are eligible for this study.
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Nina Bhardwaj, MD, PhD | New York University School of Medicine |
Study ID Numbers: | R01AI44628, R01 AI44628 |
Study First Received: | April 11, 2003 |
Last Updated: | August 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00058734 |
Health Authority: | United States: Food and Drug Administration |
Dendritic Cell Immunotherapy Acute HIV Human Immunodeficiency Virus |
AIDS HIV Therapeutic Vaccine Treatment Experienced Treatment Interruption |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |