CompletedNCT01940198REfLecTUpdated Sep 12, 2013

Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia

An observational study in HIV, sponsored by Holdsworth House Medical Practice. Completed at 1 site in Australia. Per ClinicalTrials.gov, last updated 2013-09-12.

Sponsored by Holdsworth House Medical Practice · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 117
Sex: All

Study summary

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.

3. 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 studied

Keywords

Atazanavir
long-term
primary care setting
sydney

In context

Lead sponsor

Holdsworth House Medical Practice is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

HIV-1 positive
Have commenced ATV between 2002-2008 (Baseline)
Follow-up data (clinical and laboratory) available from baseline

Exclusion criteria

Exclusion Criteria:

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)

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 117 participants (actual)

What researchers measure

Primary outcomes

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.
Time frame: 1 year

Secondary outcomes

Proportion of HIV-1 infected participants with atazanavir experience
1\. Therapeutic efficacy of atazanavir
Time frame: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
Tolerability to atazanavir
Time frame: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
ART treatment history
Time frame: 1 year
Proportion of HIV-1 infected participants with atazanavir experience
contraindicated therapy
Time frame: 1 year

Study locations

1 site

Holdsworth House Medical Practice
Sydney, New South Wales 2010, Australia

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2010, a primary completion of Aug 2011 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 1, 2010
First posted: Sep 12, 2013
Start: Apr 2010
Primary completionActual: Aug 2011
CompletionActual: Sep 2012
Last update: Sep 12, 2013

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01940198
Lead sponsor: Holdsworth House Medical Practice
Collaborators: Bristol-Myers Squibb
Responsible party: Dr. Mark Bloch (Principal Investigator, Holdsworth House Medical Practice) — Principal investigator
First posted: Sep 12, 2013
Start date: Apr 2010
Primary completion: Aug 2011
Completion: Sep 2012
Last update: Sep 12, 2013

Study contacts

Mark Bloch, Dr.

principal investigator · Holdsworth House Medical Practice

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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