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IL-7 Receptor Polymorphisms and Immune Recovery With HAART

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ClinicalTrials.gov Identifier: NCT00168207
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 20, 2012
Information provided by (Responsible Party):

September 9, 2005
September 15, 2005
January 20, 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 Model: Cohort
Time Perspective: Retrospective
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Retention:   Samples With DNA
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.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Jennifer Hoy, The Alfred
The Alfred
National Health and Medical Research Council, Australia
Study Director: Jennifer Hoy, A/Prof The Alfred
Principal Investigator: Sharon Lewin, Professor Alfred Hospital, Melbourne, Vic 3004
The Alfred
January 2012