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
  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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, 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 Hospital
Principal Investigator: Sharon Lewin, Professor Alfred Hospital, Melbourne, Vic 3004
  More Information

No publications provided

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
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The Alfred:
Treatment Experienced
HIV

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 July 22, 2014