Trial Review

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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
ACTRN12605000496617
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
23/09/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Date results information initially provided
13/11/2019
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
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
1/11/2004
Actual
5/01/2005
Date of last participant enrolment
Anticipated
Actual
30/06/2006
Date of last data collection
Anticipated
Actual
1/03/2007
Sample size
Target
15
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 768 0
Commercial sector/Industry
Name [1] 768 0
Cellesits
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
01/11/2004
Ethics approval number [1] 2015 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Singh K, Howard JL, Wild SP, Jones SL, Hoy J, Lewin SR. Human cytomegalovirus (CMV)-specific CD8+ T-cell responses are reduced in HIV-infected individuals despite CD4+ T-cell recovery. Clinical Immunology, 2007, 124: 200-206
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

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.