- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00168207
IL-7 Receptor Polymorphisms and Immune Recovery With HAART
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital, Commercial Road
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Jennifer Hoy, A/Prof, The Alfred
- Principal Investigator: Sharon Lewin, Professor, Alfred Hospital, Melbourne, Vic 3004
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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