Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000552684
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
29/09/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of naive T-cells in the pathogenesis of T-cell decline and long-term persistence of HIV infection.
Scientific title
The role of naive T-cells in the pathogenesis of T-cell decline and long-term persistence of HIV infection.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 677 0
Condition category
Condition code
Infection 751 751 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
The overall goal of this project is to provide a comprehensive analysis of the role of naive T-cells in the pathogenesis of T-cell decline and long-term persistence of HIV infection.

The study aims to determine the origin of HIV infected naive T-cells in vivo by assessing the viral relatedness between HIV strains from naive and memory CD4 T-cells. Furthermore the question of whether infection of naive CD4 T-cells is a productive infection will be assessed by investigating the degree of diversity between the sequences obtained from the naive T-cells. To do this we will be studying ten chronically infected individuals. Naive and memory CD4 T-cells from these individuals will be purified using a Magnetic Activated Cell Sorting (MACS) strategy. Envelope sequences from these cell subsets and from plasma will then be isolated and subjected to diversity calculation.
This is a cross-sectional study.
Intervention code [1] 639 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 938 0
To determine the origin of HIV infected naive T-cells in vivo
Timepoint [1] 938 0
Secondary outcome [1] 1793 0
1. Whether infection of naive T-cells is productive (indicated by degree of ongoing viral replication shown by sequence evolution).
Timepoint [1] 1793 0
Secondary outcome [2] 1794 0
2. Whether there is on-going viral trafficking between these cellular compartments and plasma.
Timepoint [2] 1794 0
Secondary outcome [3] 1795 0
3. The degree of replication within the naive T-cell compartment.
Timepoint [3] 1795 0
Secondary outcome [4] 1796 0
4. Whether any sequence evolution found in (3) has been stochastic or driven by selective evolutionary pressure.
Timepoint [4] 1796 0

Eligibility
Key inclusion criteria
HIV positive by ELISA and Western Blot (n=10)VL >2,000, CD4 >350
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
1/10/2005
Date of last participant enrolment
Anticipated
Actual
30/06/2006
Date of last data collection
Anticipated
Actual
30/06/2008
Sample size
Target
75
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 832 0
Government body
Name [1] 832 0
NHMRC
Country [1] 832 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 701 0
Government body
Name [1] 701 0
NHMRC
Address [1] 701 0
Country [1] 701 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2095 0
Alfred Hospital
Ethics committee address [1] 2095 0
Melbourne
Ethics committee country [1] 2095 0
Australia
Date submitted for ethics approval [1] 2095 0
Approval date [1] 2095 0
30/06/2005
Ethics approval number [1] 2095 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Wightman F, Solomon A, Khoury G, Green J, Gorry PR, Hoy J, Crowe SM, Cameron PU, Lewin SR. Naive CD4+ T-cells are a long term stable reservoir in individuals receiving antiretroviral therapy J Inf Dis 2010; 202: 1738-48
Public notes

Contacts
Principal investigator
Name 35149 0
Address 35149 0
Country 35149 0
Phone 35149 0
Fax 35149 0
Email 35149 0
Contact person for public queries
Name 9828 0
Professor Sharon Lewin
Address 9828 0
Alfred Infectious Diseases Unit
The Alfred Hospital
2nd Floor
Burnet Institute
Commercial Road
Melbourne VIC 3004
Country 9828 0
Australia
Phone 9828 0
+61 3 92763009
Fax 9828 0
+61 3 92762431
Email 9828 0
[email protected]
Contact person for scientific queries
Name 756 0
Ms Fiona Wightman
Address 756 0
Department of Medicine
Monash University Central and Eastern Clinical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 756 0
Australia
Phone 756 0
+61 3 99030183
Fax 756 0
+61 3 92762431
Email 756 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.