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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00168259




Registration number
NCT00168259
Ethics application status
Date submitted
13/09/2005
Date registered
15/09/2005
Date last updated
20/01/2012

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
Secondary ID [1] 0 0
185/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
CMV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

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
1. HIV positive with history of documented HCV infection

2. Over 18 years old

3. HIV positive

4. Antiretroviral naive, starting on antiretroviral therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
20
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
The Alfred
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Cellestis
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study is designed to evaluate interferon responses to CMV in HIV positive individuals and
a component will look at interferon responses to CMV in HIV positive individuals over time
after commencement of antiretroviral therapy. We will also look at the correlation between
CD4 T cell numbers and HLA type with the interferon response.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon Lewin, Professor
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00168259