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

HIV Clinical Trial

— REfLecT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940198
• Other study ID #: AI424-417 ST
• Status: Completed
• Phase: N/A
• First received: June 1, 2010
• Last updated: September 8, 2013
• Start date: April 2010
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: Holdsworth House Medical Practice
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice	Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of HIV-1 infected participants with atazanavir experience	Proportion of patients who continue on atazanavir for 2 years or greater from baseline to termination/current.	1 year	No
Secondary	Proportion of HIV-1 infected participants with atazanavir experience	1. Therapeutic efficacy of atazanavir	1 year	No
Secondary	Proportion of HIV-1 infected participants with atazanavir experience	Tolerability to atazanavir	1 year	No
Secondary	Proportion of HIV-1 infected participants with atazanavir experience	ART treatment history	1 year	No
Secondary	Proportion of HIV-1 infected participants with atazanavir experience	contraindicated therapy	1 year	No