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Trial registered on ANZCTR


Registration number
ACTRN12605000496617
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of interferon-gamma responses to HCMV infection in HIV positive individuals
Scientific title
Evaluation of interferon-gamma responses to HCMV infection in HIV positive individuals
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 620 0
Condition category
Condition code
Infection 693 693 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
No intervention
Intervention code [1] 643 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 845 0
To evaluate interferon responses to CMV in HIV positive individuals
Timepoint [1] 845 0
Secondary outcome [1] 1681 0
Will also look at the correlation between CD4 T cell numbers and HLA type with the interferon response.
Timepoint [1] 1681 0

Eligibility
Key inclusion criteria
HIV positive with history of documented HCV infection.
Minimum age
18 Years
Maximum age
Not stated
Gender
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
Active, not recruiting
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)

Funding & Sponsors
Funding source category [1] 768 0
Commercial sector/Industry
Name [1] 768 0
Cellesits
Address [1] 768 0
Country [1] 768 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cellestis
Address
Country
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2015 0
Alfred Hospital
Ethics committee address [1] 2015 0
Ethics committee country [1] 2015 0
Australia
Date submitted for ethics approval [1] 2015 0
Approval date [1] 2015 0
Ethics approval number [1] 2015 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36065 0
Address 36065 0
Country 36065 0
Phone 36065 0
Fax 36065 0
Email 36065 0
Contact person for public queries
Name 9832 0
Professor Sharon Lewin
Address 9832 0
Infectious Diseases Unit
Alfred Hospital
2nd Floor
Burnet Institute
Commercial Road
Melbourne VIC 3004
Country 9832 0
Australia
Phone 9832 0
+61 3 92763009
Fax 9832 0
+61 3 92762431
Email 9832 0
S.Lewin@alfred.org.au
Contact person for scientific queries
Name 760 0
Professor Sharon Lewin
Address 760 0
Infectious Diseases Unit
Alfred Hospital
2nd Floor
Burnet Institute
Commercial Road
Melbourne VIC 3004
Country 760 0
Australia
Phone 760 0
+61 3 92763009
Fax 760 0
+61 3 92762431
Email 760 0
as above

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary