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IL-7 Receptor Polymorphisms and Immune Recovery With HAART

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168207
First Posted: September 15, 2005
Last Update Posted: January 20, 2012
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.
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Jennifer Hoy, The Alfred
  Purpose
The aim is to investigate the hypothesis that IL7-receptor polymorphisms contribute to the differential immune recovery of CD4 + T cells following HAART

Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Relationship of Single Nucleotide Polymorphisms in the Interleukin-7 Receptor-α Gene to CD4+ Immune Recovery in HIV Infected Patients Who Begin Antiretroviral Treatment With HAART

Resource links provided by NLM:


Further study details as provided by Jennifer Hoy, The Alfred:

Biospecimen Retention:   Samples With DNA
Plasma, PBMC and DNA

Enrollment: 106
Study Start Date: May 2005
Study Completion Date: May 2009
Detailed Description:

AIM: To examine the association between the four haplotypes of IL-7Rα gene and a cohort of HIV infected patients who have commenced HAART with varying CD4+ T lymphocyte responses.

METHODS: IL-7Rα gene SNPs and haplotypes will be measured by constructing DNA pools, and PCR amplification and DNA sequencing. IL-7Rα expression will be examined using constitutive expression of IL-7Rα, IL-7Rα gene expression, and inducible expression of IL7Rα.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV infected patients on HAART
Criteria

Inclusion Criteria:

  • Men or women at least 18 years of age
  • First antiretroviral regimen composed of HAART as defined by at least three antiretrovirals
  • Controlled viremia for a period of at least 12 months following commencement of HAART. Controlled viremia is defined as HIV viral load of ≤ 500 copies/mL on bDNA testing (versions 2 and 3) and <400 copies/ml measured by RT-PCR assay by 6 months treatment.
  • CD4 cell count <500 at commencement of HAART
  • Measurement of CD4+ cell count on at least 3 time points, in the 12 months post commencement of HAART.

Exclusion Criteria:

  • Exclude patients treated for HIV seroconversion illness
  • Exclude patients on immunomodulatory therapy such as IL-2, hydroxyurea or prednisolone or who have received an HIV therapeutic vaccine
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00168207


Locations
Australia, Victoria
The Alfred Hospital, Commercial Road
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
The Alfred
National Health and Medical Research Council, Australia
Investigators
Study Director: Jennifer Hoy, A/Prof The Alfred
Principal Investigator: Sharon Lewin, Professor Alfred Hospital, Melbourne, Vic 3004
  More Information

Responsible Party: Jennifer Hoy, Professor Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier: NCT00168207     History of Changes
Other Study ID Numbers: 112/05
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: January 20, 2012
Last Verified: January 2012

Keywords provided by Jennifer Hoy, The Alfred:
Treatment Experienced
HIV

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