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Completed

NCT Number: NCT01940198

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

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

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Key information

Conditions

HIV

Sex eligibility

All sexes

Study type

Observational

Primary location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

About this study

This observational study will aim to determine long term atazanavir experience in HIV-1 infected patients in a primary care setting.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Proportion of HIV-1 infected participants with atazanavir experience

    Time frame: 1 year

    • 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

Sponsors and collaborators

Lead sponsor

Holdsworth House Medical Practice

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Acronym: REfLecT

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 12, 2013
Registry last updated
Sep 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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