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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/NCT00377169




Registration number
NCT00377169
Ethics application status
Date submitted
14/09/2006
Date registered
15/09/2006
Date last updated
1/11/2016

Titles & IDs
Public title
Collection of Blood Samples From SMART Study Participants for Future Genetic Studies
Scientific title
Genomics: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Secondary ID [1] 0 0
SMART
Secondary ID [2] 0 0
CPCRA 065H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 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
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Coenrollment in the SMART study

- Parent or guardian willing to provide informed consent, if applicable
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2006
Sample size
Target
3261
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
American Samoa
State/province [8] 0 0
Highgate Hill
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Chile
State/province [11] 0 0
Santiago
Country [12] 0 0
Denmark
State/province [12] 0 0
Brendstrupgaardvej Aarhus
Country [13] 0 0
Finland
State/province [13] 0 0
Helsinki
Country [14] 0 0
Gambia
State/province [14] 0 0
Bonn
Country [15] 0 0
Gambia
State/province [15] 0 0
Heidelberg
Country [16] 0 0
Germany
State/province [16] 0 0
Frankfurt
Country [17] 0 0
Germany
State/province [17] 0 0
Hamburg
Country [18] 0 0
Germany
State/province [18] 0 0
Koln
Country [19] 0 0
Germany
State/province [19] 0 0
Munich
Country [20] 0 0
Japan
State/province [20] 0 0
Tokyo
Country [21] 0 0
Morocco
State/province [21] 0 0
Casablanca
Country [22] 0 0
New Zealand
State/province [22] 0 0
Wellington
Country [23] 0 0
New Zealand
State/province [23] 0 0
Christchurch
Country [24] 0 0
New Zealand
State/province [24] 0 0
Hamilton
Country [25] 0 0
Poland
State/province [25] 0 0
Koszarowa
Country [26] 0 0
Portugal
State/province [26] 0 0
Cascais
Country [27] 0 0
Portugal
State/province [27] 0 0
Lisbon
Country [28] 0 0
Portugal
State/province [28] 0 0
Porto
Country [29] 0 0
Uruguay
State/province [29] 0 0
Montevideo

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Community Programs for Clinical Research on AIDS
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to collect blood samples from SMART study participants to use in
future genetic studies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00377169
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jonathan Uy, MD
Address 0 0
AIDS Research Alliance Chicago (ARAC), University of Illinois at Chicago
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