Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.



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For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
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Learn more about MFA and its importance on the Australian Signals Directorate website.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01940198




Registration number
NCT01940198
Ethics application status
Date submitted
1/06/2010
Date registered
12/09/2013
Date last updated
12/09/2013

Titles & IDs
Public title
Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia
Scientific title
Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia
Secondary ID [1] 0 0
AI424-417 ST
Universal Trial Number (UTN)
Trial acronym
REfLecT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Condition category
Condition code

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
Primary outcome [1] 0 0
Proportion of HIV-1 infected participants with atazanavir experience
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Proportion of HIV-1 infected participants with atazanavir experience
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Proportion of HIV-1 infected participants with atazanavir experience
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Proportion of HIV-1 infected participants with atazanavir experience
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Proportion of HIV-1 infected participants with atazanavir experience
Timepoint [4] 0 0
1 year

Eligibility
Key inclusion criteria
1. HIV-1 positive
2. Have commenced ATV between 2002-2008 (Baseline)
3. Follow-up data (clinical and laboratory) available from baseline
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients not commenced ATV between 2002-2008
2. No follow-up data (clinical and laboratory) available from baseline
3. Patient 'lost to follow-up' with < 2 years of follow-up data (Clinical and laboratory)

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Holdsworth House Medical Practice
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Mark Bloch, Dr.
Address 0 0
Holdsworth House Medical Practice
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01940198