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

September 8, 2013 updated by: Dr. Mark Bloch, Holdsworth House Medical Practice
This observational study will aim to determine long-term atazanavir experience in a high HIV caseload primary care practice in Sydney, Australia.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of HIV-1 infected participants with atazanavir experience
Time Frame: 1 year
1. Therapeutic efficacy of atazanavir
1 year
Proportion of HIV-1 infected participants with atazanavir experience
Time Frame: 1 year
Tolerability to atazanavir
1 year
Proportion of HIV-1 infected participants with atazanavir experience
Time Frame: 1 year
ART treatment history
1 year
Proportion of HIV-1 infected participants with atazanavir experience
Time Frame: 1 year
contraindicated therapy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holdsworth House Medical Practice

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Mark Bloch, Dr., Holdsworth House Medical Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 1, 2010

First Submitted That Met QC Criteria

September 8, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

September 12, 2013

Last Update Submitted That Met QC Criteria

September 8, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AI424-417 ST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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