Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05680948
Status:
RECRUITING
Last Update Posted:
2023-02-24
First Post:
2022-12-05
Brief Title:
Extended Follow-Up of the ISS T-003 Trial Volunteers ISS T-003 EF-UP2020
Sponsor:
Istituto Superiore di SanitÃ
Organization:
Istituto Superiore di SanitÃ
Study Overview
Official Title:
A Roll-Over Observational Study for the Extended Follow-Up of the Volunteers of the ISS T-003 Trial ISS T-003 EF-UP2020
Status:
RECRUITING
Status Verified Date:
2023-01
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:
T003EFUP2020
Brief Summary:
A further extension of the follow-up of the volunteers of the ISS T-003 trial is being conducted in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination
Detailed Description:
The volunteers enrolled in the South African ISS T-003 trial ClinicalTrialsgov NCT01513135 SANCTR DOH-27-0211-3351 were recently enrolled in an observational study to extend the follow-up of the trial The results of this study ISS T-003 EF-UP ClinicalTrialsgov NCT02712489 SANCTR DOH-27-0615-4948 indicate the maintenance of anti-Tat Ab in a vast proposition of vaccinees
The new roll-over observational study ISS T-003 EF-UP2020 SANCTR DOH-27-072022-7347 is to be conducted to further extend the follow-up of the participants of the ISS T-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination
To this aim volunteers of the ISS T-003 study are included in a new 6-months study with visits at weeks 0 and 24 during which the persistence and levels of anti-Tat antibodies primary endpoint and the CD4 T-cell and HIV-1 plasma viraemia levels secondary endpoint will be evaluated In addition depending on the availability of residual specimens PBMC serum and plasma further laboratory tests will be performed to investigate in-depth the immunological and virological profile of the volunteers Clinical signs and symptoms of disease progression and AIDS-defining events will also be recorded
The new roll-over observational study ISS T-003 EF-UP2020 SANCTR DOH-27-072022-7347 is to be conducted to further extend the follow-up of the participants of the ISS T-003 trial in order to evaluate the persistence of vaccine immunogenicity as well as of the immunological and virological effects induced by the therapeutic immunization with Tat after about 10 years from vaccination
To this aim volunteers of the ISS T-003 study are included in a new 6-months study with visits at weeks 0 and 24 during which the persistence and levels of anti-Tat antibodies primary endpoint and the CD4 T-cell and HIV-1 plasma viraemia levels secondary endpoint will be evaluated In addition depending on the availability of residual specimens PBMC serum and plasma further laboratory tests will be performed to investigate in-depth the immunological and virological profile of the volunteers Clinical signs and symptoms of disease progression and AIDS-defining events will also be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None