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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/NCT00206531
Registration number
NCT00206531
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
4/10/2006
Titles & IDs
Public title
The Role of Naive T-Cells in HIV Pathogenesis
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Scientific title
Role of Naive T-Cells in the Pathogenesis of T-Cell Decline and Long Term Persistence of HIV
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Secondary ID [1]
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114/05
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
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Part 1:
- HIV positive by ELISA and Western Blot VL >2,000, CD4 >350
Part 2:
- HIV positive by ELISA and Western Blot
- Established Chronic infection (15 individuals)
- Acute infection (15 individuals).
- Any viral load or CD4 count.
- No therapy.
- Any individual who initiates HAART as determined by the treating physician
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Minimum age
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Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- none
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
While HIV mainly infects mature T-cells it can also infect newly produced (or naïve) T-cells.
These infected naïve T cells may then act a viral reservoir even in patients with
undetectable viral loads. Understanding when and how these cells are infected is important
because it could help us to understand why patients fail therapy even if they have a
persistently undetectable viral load.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00206531
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sharon R Lewin
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Address
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Director, Infectious Diseases Unit, The Alfred Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sharon R Lewin
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Address
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Country
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Phone
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+61 3 9276 3009
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00206531
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