Viewing Study NCT02712489



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Study NCT ID: NCT02712489
Status: COMPLETED
Last Update Posted: 2016-12-29
First Post: 2016-03-04

Brief Title: A Roll-over Observational Study for the Extended Follow-up of the Volunteers of the ISS T-003 Trial
Sponsor: Barbara Ensoli MD PhD
Organization: Istituto Superiore di Sanità

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-UP
Status: COMPLETED
Status Verified Date: 2016-12
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: ISST-003EF-UP
Brief Summary: A roll-over observational study ISS T-003 EF-UP is being conducted to extend the follow-up of the volunteers 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
Detailed Description: An open label non-interventional study roll-over study ISS T-003 EF-UP is being conducted to follow-up the persistence of vaccine humoral responses as well as of the immunological and virological effects induced by the therapeutic immunization with TatTo this aim volunteers of the ISS T-003 study are included in one year study with visits at weeks 0 and 24 and 54

To assess the anti-Tat humoral immune response by the determination and titration of IgM IgG and IgA anti-Tat antibodies primary endpoint and to evaluate CD4 T cell counts and HIV-1 plasma viraemia as secondary endpoint

In addition depending on the availability of residual specimens PBMC serum and plasma further laboratory tests ie HIV DNA copies in blood to investigate in-depth the immunological and virological profile of the volunteers is being performed

Physical examination is being performed to monitor the clinical status of the volunteers and to record the appearance of clinical signs and symptoms of disease progression as well as AIDS-defining events data or records related to ARV treatment compliance Pregnancy onset for female participants will also be recorded

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