Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-29 @ 1:34 PM
Study NCT ID:
NCT01024595
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT
Sponsor:
Istituto Superiore di SanitÃ
Organization:
Study Overview
Official Title:
Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in Hiv-1 Infected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2010-02
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:
ISS OBS T-001
Brief Summary:
The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe, well tolerated and immunogenic. The present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and cellular immune responses. The results of the present study will be key for the design of future phase II trials, particularly for the definition of the optimal schedule for boosting immunizations.
All individuals (27) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. During these visits, which are performed within the schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to the routine virological, hematological and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be evaluated.
All individuals (27) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. During these visits, which are performed within the schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to the routine virological, hematological and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be evaluated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: