Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000495628
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
23/09/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Date results information initially provided
13/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Relationship of single nucleotide polymorphisms in the Interleukin-7 receptor-alpha gene to CD4+ immune recovery in HIV infected patients who begin antiretroviral treatment with HAART
Scientific title
The Relationship of single nucleotide polymorphisms in the Interleukin-7 receptor-gene to CD4+ immune recovery in HIV infected patients who begin antiretroviral treatment with HAART
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The determinants of immune recovery following institution of Highly Active Antiretroviral Treatment in HIV infected patients 619 0
Condition category
Condition code
Infection 692 692 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None. This is an observational study.
Intervention code [1] 3162 0
Not applicable
Comparator / control treatment
There is no control group. This is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 843 0
Evaluation of the determinants of immune recovery (namely CD4+ T lymphocyte and HIV viral load). These factors include age, sex, cigarette smoking, Hepatitis C co-infection, CD8+ T-lymphocyte count, nadir and baseline CD4+ T-lymphocyte, baseline HIV viral load, time to undetectable HIV viral load and composition of HAART.
Timepoint [1] 843 0
There is no timepoint for this outcome.
Primary outcome [2] 4487 0
Investigating whether interleukin-7 receptor (IL-7Ralpha) polymorphisms and IL-7Ralpha expression may be a determinant of immune recovery.
Timepoint [2] 4487 0
There is no timepoint for this outcome.
Secondary outcome [1] 7594 0
There is no secondary outcome.
Timepoint [1] 7594 0
There is no timepoint for this outcome.

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
15/08/2005
Date of last participant enrolment
Anticipated
Actual
27/09/2008
Date of last data collection
Anticipated
Actual
27/09/2008
Sample size
Target
110
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 767 0
Government body
Name [1] 767 0
NHMRC program grant.
Country [1] 767 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
GPO Box 1421 Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 3249 0
None
Name [1] 3249 0
New secondary sponsor name. Please modify.
Address [1] 3249 0
New secondary sponsor address. Please modify.
Country [1] 3249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2014 0
The Alfred Hospital
Ethics committee address [1] 2014 0
Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 2014 0
Australia
Date submitted for ethics approval [1] 2014 0
Approval date [1] 2014 0
30/06/2005
Ethics approval number [1] 2014 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Rajasuriar R, Booth D, Solomon A, Chua K, Spelman T, Gouillou M, Schlub T, Davenport M, Crowe S, Elliott J, Hoy J, Fairley C, Stewart G, Cameron P, Lewin SR. Biological determinants of immune reconstitution in HIV-infected patients receiving antiretroviral therapy: The role of Interleukin 7 and Interleukin 7 receptor a and Microbial translocation. J Inf Dis 2010; 202: 1254-64
Public notes

Contacts
Principal investigator
Name 36167 0
Address 36167 0
Country 36167 0
Phone 36167 0
Fax 36167 0
Email 36167 0
Contact person for public queries
Name 9831 0
Associate Professor Jennifer Hoy
Address 9831 0
Infectious Diseases Unit
Alfred Hospital
2nd Floor
Burnet Institute
Commercial Road
Mebourne VIC 3004
Country 9831 0
Australia
Phone 9831 0
+61 3 92766900
Fax 9831 0
+61 3 92762431
Email 9831 0
[email protected]
Contact person for scientific queries
Name 759 0
Professor Sharon Lewin
Address 759 0
Infectious Diseases Unit
Alfred Hospital
2nd Floor
Burnet Institute
Commercial Road
Mebourne VIC 3004
Country 759 0
Australia
Phone 759 0
+61 3 92763009
Fax 759 0
+61 3 92762431
Email 759 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.