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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00168207




Registration number
NCT00168207
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
20/01/2012

Titles & IDs
Public title
IL-7 Receptor Polymorphisms and Immune Recovery With HAART
Scientific title
The Relationship of Single Nucleotide Polymorphisms in the Interleukin-7 Receptor-a Gene to CD4+ Immune Recovery in HIV Infected Patients Who Begin Antiretroviral Treatment With HAART
Secondary ID [1] 0 0
112/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 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
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
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
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital, Commercial Road - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim is to investigate the hypothesis that IL7-receptor polymorphisms contribute to the
differential immune recovery of CD4 + T cells following HAART
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168207
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Hoy, A/Prof
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries