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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/NCT00662194




Registration number
NCT00662194
Ethics application status
Date submitted
17/04/2008
Date registered
21/04/2008
Date last updated
10/03/2014

Titles & IDs
Public title
Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
Scientific title
A Study of Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C or Hepatitis B
Secondary ID [1] 0 0
ALF-55/08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-hepatitis Co-infection 0 0
HIV Infections 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
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 - HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3

2 - HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3

3 - HIV-HBV co-infected and receiving ART and CD4 count <200cells/mm3

4 - HIV-HBV co-infected and not receiving ART

5 - HIV-HCV co-infected & receiving anti-retroviral therapy (ART) and CD4 count > 500cells/mm3

6 - HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3

7 - HIV-HCV co-infected and receiving ART and CD4 count <200cells/mm3

8 - HIV-HCV co-infected and not receiving ART
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
TLR change with HIV co-infection therapy
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
- HIV and either HBV or HCV co-infection

- 18 years and older

- able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- HIV-HBV-HCV triple infection

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2014
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash Medical Centre
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Institutes of Health (NIH)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Data from this study will provide the first information how the innate immune system may be
altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor
changes with HIV co-infection therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00662194
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joe Sasadeusz, MD, PhD
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
Jennifer Audsley, PhD
Address 0 0
Country 0 0
Phone 0 0
+613 99030184
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00662194