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Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia (REfLecT)
This study has been completed.
Sponsor:
Holdsworth House Medical Practice
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier:
NCT01940198
First received: June 1, 2010
Last updated: September 8, 2013
Last verified: September 2013
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Purpose
This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.
| Condition |
|---|
| HIV |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia |
Resource links provided by NLM:
Further study details as provided by Dr. Mark Bloch, Holdsworth House Medical Practice:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ]1. Therapeutic efficacy of atazanavir
- Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ]Tolerability to atazanavir
- Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ]ART treatment history
- Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ]contraindicated therapy
| Enrollment: | 117 |
| Study Start Date: | April 2010 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | 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.
Criteria
Inclusion Criteria:
- HIV-1 positive
- Have commenced ATV between 2002-2008 (Baseline)
- Follow-up data (clinical and laboratory) available from baseline
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940198
Please refer to this study by its ClinicalTrials.gov identifier: NCT01940198
Locations
| Australia, New South Wales | |
| Holdsworth House Medical Practice | |
| Sydney, New South Wales, Australia, 2010 | |
Sponsors and Collaborators
Holdsworth House Medical Practice
Bristol-Myers Squibb
Investigators
| Principal Investigator: | Mark Bloch, Dr. | Holdsworth House Medical Practice |
More Information
| Responsible Party: | Dr. Mark Bloch, Principal Investigator, Holdsworth House Medical Practice |
| ClinicalTrials.gov Identifier: | NCT01940198 History of Changes |
| Other Study ID Numbers: |
AI424-417 ST |
| Study First Received: | June 1, 2010 |
| Last Updated: | September 8, 2013 |
Keywords provided by Dr. Mark Bloch, Holdsworth House Medical Practice:
|
Atazanavir long-term primary care setting sydney |
Additional relevant MeSH terms:
|
Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on July 24, 2017