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

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ClinicalTrials.gov Identifier: NCT01940198
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : September 12, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice

Study Description
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Brief Summary:
This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.

Condition or disease
HIV

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

  1. To illustrate long term therapeutic efficacy of atazanavir in ART naïve and experienced HIV-1 infected patients.
  2. To illustrate long term tolerability to atazanavir in ART naïve and experienced HIV-1 infected patients.
  3. To identify ART treatment history in ART naïve and experienced HIV-1 infected patients on ATV.
  4. To identify contraindicated therapy in ART naïve and experienced HIV-1 infected patients on ATV.

Study Design
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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia
Study Start Date : April 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ]
    1. Therapeutic efficacy of atazanavir

  2. Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ]
    Tolerability to atazanavir

  3. Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ]
    ART treatment history

  4. Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ]
    contraindicated therapy


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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:

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

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 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