IL-7 Receptor Polymorphisms and Immune Recovery With HAART

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Jennifer Hoy, The Alfred
ClinicalTrials.gov Identifier:
NCT00168207
First received: September 9, 2005
Last updated: January 19, 2012
Last verified: January 2012

September 9, 2005
January 19, 2012
May 2005
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Complete list of historical versions of study NCT00168207 on ClinicalTrials.gov Archive Site
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IL-7 Receptor Polymorphisms and Immune Recovery With HAART
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

The aim is to investigate the hypothesis that IL7-receptor polymorphisms contribute to the differential immune recovery of CD4 + T cells following HAART

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Retention:   Samples With DNA
Description:

Plasma, PBMC and DNA

Non-Probability Sample

HIV infected patients on HAART

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.
 
Completed
106
May 2009
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00168207
112/05
No
Jennifer Hoy, The Alfred
The Alfred
National Health and Medical Research Council, Australia
Study Director: Jennifer Hoy, A/Prof The Alfred Hospital
Principal Investigator: Sharon Lewin, Professor Alfred Hospital, Melbourne, Vic 3004
The Alfred
January 2012

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