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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Role of Naive T-Cells in the Pathogenesis of T-Cell Decline and Long Term Persistence of HIV
Secondary ID [1] 0 0
114/05
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
-

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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- none

Study design
Purpose
Duration
Longitudinal
Selection
Timing
Prospective
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00206531
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon R Lewin
Address 0 0
Director, Infectious Diseases Unit, The Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sharon R Lewin
Address 0 0
Country 0 0
Phone 0 0
+61 3 9276 3009
Fax 0 0
Email 0 0
S.Lewin@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00206531