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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:
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
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Holdsworth House Medical Practice:

Primary Outcome Measures:
  • Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    1. Therapeutic efficacy of atazanavir

  • Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Tolerability to atazanavir

  • Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    ART treatment history

  • Proportion of HIV-1 infected participants with atazanavir experience [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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)
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.
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by 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 September 26, 2016