Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04263207
Status:
SUSPENDED
Last Update Posted:
2024-03-05
First Post:
2020-02-05
Brief Title:
Observational Study for the Evaluation of the Role of HIV-1 Tat Protein and Anti-Tat Immune Response In HIV Reservoir
Sponsor:
Barbara Ensoli MD PhD
Organization:
Istituto Superiore di SanitÃ
Study Overview
Official Title:
Observational Study for the Evaluation of the Role of HIV-1 Tat Protein and Anti-Tat Immune Response in Peripheral Blood HIV Reservoir Dynamics
Status:
SUSPENDED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study halted prematurely due to the difficulties in dedicating the human resources necessary to conduct the study deriving from the COVID-19 pandemic but potentially will resume
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISS OBS T-005
Brief Summary:
A longitudinal observational study in HIV-infected subjects receiving cART addressed to explore the effect of the Tat protein and anti-Tat immunity on the formation and maintenance of HIV-1 virus reservoir
Detailed Description:
The study is designed as a longitudinal observational study addressed to identify the effects of Tat protein and humoralcellular anti-Tat immune responses induced in the natural infection or by Tat vaccination in HIV-1 reservoir dynamics in blood of HIV infected patients receiving cART HIV DNA data will be used for analyzing the decay dynamics
The primary objective of the study is to determine the rate of decay of total HIV DNA in blood of anti-Tat antibody Ab positive versus anti-Tat Ab negative HIV patients receiving cART
The secondary objectives of the study are to relate the HIV DNA decay data to
1 the persistence of anti-Tat humoral responses
2 biomarkers of HIV reservoir stability potentially affected by the Tat protein or anti-Tat immune responses including i apoptoticsurvival index of CD4 T cells ii reactivation dynamics of latent HIV in resting CD4 T cells upon exposure to Tat protein andor activation stimuli iii cellular and humoral biomarkers relevant to inflammation and immune dysregulation
The primary objective of the study is to determine the rate of decay of total HIV DNA in blood of anti-Tat antibody Ab positive versus anti-Tat Ab negative HIV patients receiving cART
The secondary objectives of the study are to relate the HIV DNA decay data to
1 the persistence of anti-Tat humoral responses
2 biomarkers of HIV reservoir stability potentially affected by the Tat protein or anti-Tat immune responses including i apoptoticsurvival index of CD4 T cells ii reactivation dynamics of latent HIV in resting CD4 T cells upon exposure to Tat protein andor activation stimuli iii cellular and humoral biomarkers relevant to inflammation and immune dysregulation
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