Trial Review

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
ACTRN12609000438257
Ethics application status
Approved
Date submitted
18/05/2009
Date registered
11/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective cohort study of individuals with primary human imune defiecncy virus (HIV) infection to determine immunological and virological factors related to disease progression"
Scientific title
A prospective cohort study of individuals with primary Human Immunodefiency Virus (HIV) infection to determine immunological and virological factors related to disease progression.
Universal Trial Number (UTN)
Trial acronym
PHIIDO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV infection 4806 0
Condition category
Condition code
Infection 237151 237151 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
There will be no intervention, as observed participants will be HIV positive and followed for a duration 2 years and assessed on various outcomes.
Intervention code [1] 236741 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 237969 0
record natural history of disease assessed at regular intervals of three months
Timepoint [1] 237969 0
2 years assessments taking place at three monthly intervals
Secondary outcome [1] 242072 0
Effect of CD4 T cells decline on Viral load increase. Blood samples which have been taken will be used to analysis this effect.
Timepoint [1] 242072 0
2 years with assessments taking place at three monthly timepoints

Eligibility
Key inclusion criteria
People diagnosed with HIV within six months of being infected
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
taking treatment for HIV

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4972 0
Government body
Name [1] 4972 0
National Centre in HIV epidemiology and clinical research
Country [1] 4972 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Barker Street
Kensington, 2052
NSW
Country
Australia
Secondary sponsor category [1] 4498 0
None
Name [1] 4498 0
Address [1] 4498 0
Country [1] 4498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7077 0
St Vincent's Hospital
Ethics committee address [1] 7077 0
376 Victoria St
darlinghurst
nsw 2010
Ethics committee country [1] 7077 0
Australia
Date submitted for ethics approval [1] 7077 0
Approval date [1] 7077 0
19/02/2009
Ethics approval number [1] 7077 0
hrec /08/186

Summary
Brief summary
The purpose of this study is to investigate how initial infection with HIV affects the immune system. We would like to study the natural history of an untreated group of people newly infected with HIV.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 29618 0
Address 29618 0
Country 29618 0
Phone 29618 0
Fax 29618 0
Email 29618 0
Contact person for public queries
Name 12865 0
Pat Grey
Address 12865 0
level 2, 376 Victoria St
darlinghurst 2011
nsw
Country 12865 0
Australia
Phone 12865 0
+ 61 2 93854951
Fax 12865 0
+61 2 93850920
Email 12865 0
[email protected]
Contact person for scientific queries
Name 3793 0
Dr Tony Kelleher
Address 3793 0
level 2, 376 Victoria Street
Darlinghurst 2011
NSW
Country 3793 0
Australia
Phone 3793 0
+61 2 83822491
Fax 3793 0
+61 2 93850920
Email 3793 0
[email protected]

No information has been provided regarding IPD availability


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.