IL-7 Receptor Polymorphisms and Immune Recovery With HAART

This study is currently recruiting participants.

Verified by The Alfred, May 2008

Sponsors and Collaborators:	The Alfred 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

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

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

Responsible Party:	The Alfred Hospital ( Professor Sharon Lewin )
Study ID Numbers:	112/05
Study First Received:	September 9, 2005
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00168207
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by The Alfred:

Treatment Experienced
HIV

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 13, 2009