Ignite Creation Date:
2024-05-05 @ 11:33 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01359800
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2011-05-17
Brief Title:
Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients
Sponsor:
Barbara Ensoli MD
Organization:
Istituto Superiore di Sanità
Study Overview
Official Title:
A Multicentre Observational Cross-sectional Study to Assess the Seroprevalence of Anti-Tat Antibodies in HIV-infected Patients in Selected Areas of Gauteng and Eastern Cape
Status:
COMPLETED
Status Verified Date:
2016-03
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-004
Brief Summary:
Tat is a key HIV regulatory protein produced very early after infection prior to virus integration and necessary for viral gene expression cell-to-cell virus transmission and disease progression Previous studies in natural HIV infection indicated that the presence of a Tat-specific immune response correlates with a lower incidence and reduced risk of progression to AIDS as compared to anti-Tat negative individuals suggesting that an immune response to Tat may exert a protective role and control the progression to AIDS in vivo
On the basis of the above mentioned consideration the present study was directed at investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African patients
On the basis of the above mentioned consideration the present study was directed at investigating the seroprevalence of anti-Tat antibodies in HIV-infected South African patients
Detailed Description:
This is an observational cross-sectional study aimed at assessing the frequency magnitude and quality of the anti-Tat antibody response in both antiretroviral ARV-treated and treatment-naïve HIV-infected South African adults and at exploring the correlation between the presence of anti-Tat antibody response and the immunological status of participants as well as with the presence of co-infections such as HBV syphilis and HPV the latter only for female participants
The study has involved 531 participants and provided important information for the planning design and conduction of future therapeutic clinical trials with the Tat-based HIV vaccine in South African individuals
This study is conducted in the frame of the Government-to-Government cooperation program N AID 8421 funded by the Italian Ministry of Foreign Affairs-Directorate General for Development Cooperation MAE-DGCS and jointly implemented by the Italian Istituto Superiore di Sanita ISS and the South African Department of Health in collaboration with the South African AIDS Vaccine Initiative of the Medical Research Council MRC-SAAVI
The study has involved 531 participants and provided important information for the planning design and conduction of future therapeutic clinical trials with the Tat-based HIV vaccine in South African individuals
This study is conducted in the frame of the Government-to-Government cooperation program N AID 8421 funded by the Italian Ministry of Foreign Affairs-Directorate General for Development Cooperation MAE-DGCS and jointly implemented by the Italian Istituto Superiore di Sanita ISS and the South African Department of Health in collaboration with the South African AIDS Vaccine Initiative of the Medical Research Council MRC-SAAVI
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