The Role of Naive T-Cells in HIV Pathogenesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Bayside Health

Brief Summary:
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.

Condition or disease
HIV Infections

Detailed Description:

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
Enrollment : 75 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Role of Naive T-Cells in the Pathogenesis of T-Cell Decline and Long Term Persistence of HIV

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206531

Contact: Sharon R Lewin +61 3 9276 3009

Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Sharon R Lewin    +61 3 9276 3009   
Sponsors and Collaborators
Bayside Health
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 Identifier: NCT00206531     History of Changes
Other Study ID Numbers: 114/05
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 4, 2006
Last Verified: June 2005

Keywords provided by Bayside Health:
Naive T-cells
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases