skip to content

Clinical Trials

MainTitle

IL-7 Receptor Polymorphisms and Immune Recovery With HAART

This study has been completed
Sponsor
The Alfred

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
History of Changes
Purpose

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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: NCT00168207

Locations

Australia
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

More Information


Responsible Party: Jennifer Hoy, Professor Jennifer Hoy, The Alfred  
ClinicalTrials.gov Identifier: NCT00168207   History of Changes  
Other Study ID Numbers: 112/05  
Study First Received: September 9, 2005  
Last Updated: January 19, 2012  

Keywords provided by Jennifer Hoy, The Alfred:

Treatment Experienced
HIV

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.