Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056758
Status:
COMPLETED
Last Update Posted:
2007-08-27
First Post:
2003-03-21
Brief Title:
HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients 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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01AI043664-04 | NIH | None | httpsreporternihgovquickSearchP01AI043664-04 |