The Role of Naive T-Cells in HIV Pathogenesis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00206531
First received: September 13, 2005
Last updated: October 3, 2006
Last verified: June 2005

September 13, 2005
October 3, 2006
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Complete list of historical versions of study NCT00206531 on ClinicalTrials.gov Archive Site
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The Role of Naive T-Cells in HIV Pathogenesis
Role of Naive T-Cells in the Pathogenesis of T-Cell Decline and Long Term Persistence of HIV

While HIV mainly infects mature T-cells it can also infect newly produced (or naïve) T-cells. These infected naïve T cells may then act a viral reservoir even in patients with undetectable viral loads. Understanding when and how these cells are infected is important because it could help us to understand why patients fail therapy even if they have a persistently undetectable viral load.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
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Inclusion Criteria:

-

Part 1:

- HIV positive by ELISA and Western Blot VL >2,000, CD4 >350

Part 2:

  • HIV positive by ELISA and Western Blot
  • Established Chronic infection (15 individuals)
  • Acute infection (15 individuals).
  • Any viral load or CD4 count.
  • No therapy.
  • Any individual who initiates HAART as determined by the treating physician

Exclusion Criteria:

  • none
Both
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Yes
Contact: Sharon R Lewin +61 3 9276 3009 S.Lewin@alfred.org.au
Australia
 
NCT00206531
114/05
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Bayside Health
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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
Bayside Health
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP