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
  Purpose

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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Role of Naive T-Cells in the Pathogenesis of T-Cell Decline and Long Term Persistence of HIV

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Estimated Enrollment: 75
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206531

Contacts
Contact: Sharon R Lewin +61 3 9276 3009 S.Lewin@alfred.org.au

Locations
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Sharon R Lewin    +61 3 9276 3009    S.Lewin@alfred.org.au   
Sponsors and Collaborators
Bayside Health
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00206531     History of Changes
Other Study ID Numbers: 114/05
Study First Received: September 13, 2005
Last Updated: October 3, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
HIV-1
Naive T-cells
CD31
Treatment Naive

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

ClinicalTrials.gov processed this record on August 21, 2014