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
  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 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

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
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

No publications provided

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
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014