IL-7 Receptor Polymorphisms and Immune Recovery With HAART

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168207
• Other study ID #: 112/05
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: January 19, 2012
• Start date: May 2005
• Est. completion date: May 2009

Study information

• Verified date: January 2012
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Observational

Clinical Trial Summary

The aim is to investigate the hypothesis that IL7-receptor polymorphisms contribute to the differential immune recovery of CD4 + T cells following HAART

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Australia	The Alfred Hospital, Commercial Road	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
The Alfred	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia,