IL-7 Receptor Polymorphisms and Immune Recovery With HAART

This study is currently recruiting participants.

Verified by The Alfred, August 2009

First Received: September 9, 2005 Last Updated: August 3, 2009 History of Changes

Sponsor:	The Alfred
Collaborator:	National Health and Medical Research Council, Australia
Information provided by:	The Alfred
ClinicalTrials.gov Identifier:	NCT00168207

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:	Cohort, 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:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by The Alfred:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Plasma, PBMC and DNA

Estimated Enrollment:	210
Study Start Date:	May 2005

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168207

Contacts

Contact: Sharon Lewin, Prof

0061 3 9076 8491

S.Lewin@alfred.org.au

Locations

Australia, Victoria
The Alfred Hospital, Commercial Road	Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jennifer Hoy, A/Prof 0061 3 9276 6900 Jennifer.Hoy@med.monash.edu.au
Sub-Investigator: Reena Rajasuriar, MPharm
Principal Investigator: Sharon Lewin, Prof

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:	The Alfred Hospital ( Professor Sharon Lewin )
Study ID Numbers:	112/05
Study First Received:	September 9, 2005
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00168207 History of Changes
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by The Alfred:

Treatment Experienced
HIV

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010