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

Completed

• Conditions: HIV

• Registration Number: NCT01940198
• Lead Sponsor: Holdsworth House Medical Practice

Brief Summary

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

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-01
• Primary Completion: 2011-08
• Study Completion: 2012-09
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-08
• Last Update Submitted: 2013-09-08
• Study First Posted: 2013-09-12
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of HIV-1 infected participants with atazanavir experience	1 year	Proportion of patients who continue on atazanavir for 2 years or greater from baseline to termination/current.

Secondary Outcome Measures

Name	Time	Method
Proportion of HIV-1 infected participants with atazanavir experience	1 year	contraindicated therapy

Trial Locations

Locations (1)

Holdsworth House Medical Practice; 🇦🇺 Sydney, New South Wales, Australia