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

June 1, 2010
September 8, 2013
April 2010
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01940198 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Long-term Atazanavir Experience in a High HIV Caseload Primary Care Practice in Sydney, Australia
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

HIV
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
September 2012
August 2011   (final data collection date for primary outcome measure)

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)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01940198
AI424-417 ST
No
Dr. Mark Bloch, Holdsworth House Medical Practice
Holdsworth House Medical Practice
Bristol-Myers Squibb
Principal Investigator: Mark Bloch, Dr. Holdsworth House Medical Practice
Holdsworth House Medical Practice
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP