Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287677
Status:
COMPLETED
Last Update Posted:
2009-11-04
First Post:
2006-02-06
Brief Title:
Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Double Strategy to Induce and Expand the T Cell Repertoire by the Administration of Growth Hormone and Vaccination in HIV-1 Infected Patients
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Concomitant administration of recombinant human growth hormone rhGH may boost the expansion of immune reconstitution and broaden specific T cell responses not achievable by vaccination alone The main objective of that study is to test the validity of this hypothesis with vaccines which are routinely administered to HIV-1 patientstetanus toxoid and hepatitis A virus vaccines in order to if proven of value use this strategy of HIV vaccination in the near future This is a pilot randomized clinical open label study aimed to investigate thymic functionality and the HIV-specific responses after administration of rhGH in HIV-1 infected patients in highly active antiretroviral therapy HAART regimen
Detailed Description:
The purpose of a therapeutic vaccine is to control induce and expand humoral and cellular immune responses capable to control HIV infection The administration of a conventional vaccine results in the expansion of peripheral clones Concomitant administration of rhGH may boost this expansion and reconstitute specific T cell responses not achievable by vaccination alone In this study we want to investigate whether the administration of rhGH expand T cell repertoire and whether there is an increase in the specific cellular responses to HIV-1 and recall antigens and lately whether this responses can be further amplified after immunization with tetanus toxoid and hepatitis A vaccines This Hypothesis will be evaluated by the measurement of thymic volume the expansion of naïve memory and effector cell subsets analysis of thymic emigrants TRECs before during and after rhGH administration and vaccination Moreover T cell receptor rearrangement specific antibodies and cellular responses to antigenic peptides will be determined
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