HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
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|ClinicalTrials.gov Identifier: NCT00056758|
Recruitment Status : Completed
First Posted : March 24, 2003
Last Update Posted : August 27, 2007
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: Autologous Dendritic Cell HIV Vaccination||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- Safety and tolerability of peptide pulsed, autologous, cultured dendritic cells
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
|United States, Pennsylvania|
|University of Pittsburgh, Pitt Treatment Evaluation Unit|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Sharon A. Riddler, MD||University of Pittsburgh|