The Role of Naive T-Cells in HIV Pathogenesis
|ClinicalTrials.gov Identifier: NCT00206531|
Recruitment Status : Unknown
Verified June 2005 by Bayside Health.
Recruitment status was: Recruiting
First Posted : September 21, 2005
Last Update Posted : October 4, 2006
|Condition or disease|
The overall goal of this project is to provide a comprehensive analysis of the role of naïve T-cells in the pathogenesis of T-cell decline and long-term persistence of HIV infection.
The study is divided into two parts.
Part 1 aims to determine the origin of HIV infected naïve T-cells in vivo by assessing the viral relatedness between HIV strains from naïve and memory CD4 T-cells. To do this we will be studying ten chronically infected individuals. Naïve and memory CD4 T-cells from these individuals will be purified using a magnetic bead sorting (MACS) strategy. Envelope sequences will then be isolated and subjected to diversity calculation
Part 2 seeks to answer whether infection of naïve T-cells is established early in infection and what the effect of antiretroviral therapy is on this subset of T-cells. We will initially examine the relative proportion of CD31+ (recent thymic emigrants) and CD31- naive CD4+ T-cells in infected acute (n=15) and chronic (n=15) infection and uninfected (n=15) individuals compared with healthy controls. We will then prospectively test individuals prior to and at 3, 6, 12, 18 and 24 months following intiation of HAART (Highly Active Antiretroviral Therapy) in individuals with acute (n=10) and chronic (n=10) HIV infection. Immunophenotyping will detemine the proportion of naïve T-cells that are CD31+ and those that are CD31-. Naïve and memory T-cell subsets will again be purified and total and integrated HIV DNA will be quantified using real-time PCR.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Role of Naive T-Cells in the Pathogenesis of T-Cell Decline and Long Term Persistence of HIV|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206531
|Contact: Sharon R Lewin||+61 3 9276 3009||S.Lewin@alfred.org.au|
|Melbourne, Victoria, Australia, 3004|
|Contact: Sharon R Lewin +61 3 9276 3009 S.Lewin@alfred.org.au|
|Principal Investigator:||Sharon R Lewin||Director, Infectious Diseases Unit, The Alfred Hospital|
|Principal Investigator:||Jenny Hoy||Head Clinical Research Unit, Infectious Diseases Unit, Alfred Hospital|