Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 9:45 PM
Study NCT ID:
NCT00058734
Status:
COMPLETED
Last Update Posted:
2007-08-27
First Post:
2003-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
Official Title:
Immune Responses to Antigen-Bearing Dendritic Cells in HIV-Infected Individuals
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:
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AI044628 | NIH | None | https://reporter.nih.gov/quic… | View |