HIVREfLecTNCT01940198
Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia
An observational study of HIV, run by Holdsworth House Medical Practice at 1 site in Australia.
Trial summary
This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV
- How many people
- 117 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2010to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cohort of HIV-1 positive patients attending Holdsworth House Medical Practice who have commenced ATV as a component of ART will be identified from review of current database. Data will be collected retrospectively from patient electronic medical records for HIV-1 positive patients that have commenced ATV from year 2002 - 2008.
Who may be able to join
- HIV-1 positive
- Have commenced ATV between 2002-2008 (Baseline)
- Follow-up data (clinical and laboratory) available from baseline
Who cannot join
- Patients not commenced ATV between 2002-2008
- No follow-up data (clinical and laboratory) available from baseline
- Patient 'lost to follow-up' with < 2 years of follow-up data (Clinical and laboratory)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
About this study
This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.
Read the detailed description
This observational study will aim to determine long term atazanavir experience in HIV-1 infected patients in a primary care setting.
- OBJECTIVES OF THE STUDY i. Primary objective Long-term (2 years or greater) atazanavir experience in HIV-1 infected patients in a primary care setting through retrospective data collection. ii. Secondary objectives
- To illustrate long term therapeutic efficacy of atazanavir in ART naïve and experienced HIV-1 infected patients.
- To illustrate long term tolerability to atazanavir in ART naïve and experienced HIV-1 infected patients.
- To identify ART treatment history in ART naïve and experienced HIV-1 infected patients on ATV.
- To identify contraindicated therapy in ART naïve and experienced HIV-1 infected patients on ATV.
- Conditions
- HIV
- Keywords
- Atazanavir, long-term, primary care setting, sydney
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of HIV-1 infected participants with atazanavir experience
Proportion of patients who continue on atazanavir for 2 years or greater from baseline to termination/current.
Measured: 1 year
Secondary outcomes (4)
Proportion of HIV-1 infected participants with atazanavir experience
- Therapeutic efficacy of atazanavir
Measured: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
Tolerability to atazanavir
Measured: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
ART treatment history
Measured: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
contraindicated therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holdsworth House Medical Practice
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Dr. Mark Bloch, Holdsworth House Medical Practice
- Investigators
- Mark Bloch, Dr., Principal investigator, Holdsworth House Medical Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940198
- Sponsor's protocol ID
- AI424-417 ST
- Acronym
- REfLecT
- Status last verified
- Sep 2013
- First submitted
- 1 Jun 2010
- Last updated
- 12 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia
- ClinicalTrials.gov ID
- NCT01940198
- Acronym / sponsor ID
- REfLecT / AI424-417 ST
- Conditions
- HIV
- Keywords
- Atazanavir, long-term, primary care setting, sydney
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Holdsworth House Medical PracticeUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.
Detailed description
This observational study will aim to determine long term atazanavir experience in HIV-1 infected patients in a primary care setting.
- OBJECTIVES OF THE STUDY i. Primary objective Long-term (2 years or greater) atazanavir experience in HIV-1 infected patients in a primary care setting through retrospective data collection. ii. Secondary objectives
- To illustrate long term therapeutic efficacy of atazanavir in ART naïve and experienced HIV-1 infected patients.
- To illustrate long term tolerability to atazanavir in ART naïve and experienced HIV-1 infected patients.
- To identify ART treatment history in ART naïve and experienced HIV-1 infected patients on ATV.
- To identify contraindicated therapy in ART naïve and experienced HIV-1 infected patients on ATV.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort of HIV-1 positive patients attending Holdsworth House Medical Practice who have commenced ATV as a component of ART will be identified from review of current database. Data will be collected retrospectively from patient electronic medical records for HIV-1 positive patients that have commenced ATV from year 2002 - 2008.
Key inclusion criteria (3 listed)
- HIV-1 positive
- Have commenced ATV between 2002-2008 (Baseline)
- Follow-up data (clinical and laboratory) available from baseline
Key exclusion criteria (3 listed)
- Patients not commenced ATV between 2002-2008
- No follow-up data (clinical and laboratory) available from baseline
- Patient 'lost to follow-up' with < 2 years of follow-up data (Clinical and laboratory)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of HIV-1 infected participants with atazanavir experience
Time frame: 1 year
Proportion of patients who continue on atazanavir for 2 years or greater from baseline to termination/current.
4 secondary outcomes
Proportion of HIV-1 infected participants with atazanavir experience
Time frame: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
Time frame: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
Time frame: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Bloch, Dr. principal investigator
Holdsworth House Medical Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Holdsworth House Medical Practice at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of HIV-1 infected participants with atazanavir experience (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2013.