IL-7 Receptor Polymorphisms and Immune Recovery With HAART

NCT ID: NCT00168207

Last Updated: 2012-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2009-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Hoy

Professor Jennifer Hoy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Hoy, A/Prof

Role: STUDY_DIRECTOR

The Alfred

Sharon Lewin, Professor

Role: PRINCIPAL_INVESTIGATOR

Alfred Hospital, Melbourne, Vic 3004

Locations

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The Alfred Hospital, Commercial Road

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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112/05

Identifier Type: -

Identifier Source: org_study_id

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