Status:
COMPLETED
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
PharmaNet
Conditions:
HIV
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to describe long term (\> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.
Detailed Description
Time perspective: Collection of historical data and longitudinal follow up. Patients will be enrolled in 2011/2012 but data will be collected from medical charts from ATV initiation date (Feb 2008 - J...
Eligibility Criteria
Inclusion
- Male or Female HIV patients ≥ 18 years old at ATV/RTV initiation treatment date
- Outpatient seen in routine consultation whatever the reason, between January 1st 2011 and March 31st 2012
- Commencing an ATV/RTV-based regimen including at least 2 nucleoside reverse transcriptase inhibitors (NRTI) after February 1st 2008 and before July 31st 2010, regardless of the current ARV treatment ongoing at enrollment visit
Exclusion
- Patient exposed to or who began ATV/RTV prior to February 1st 2008, or after July 31st 2010 or without a known start date for ATV/RTV therapy
- Exposure to more than 4 weeks of any ARV prior to initiation of ATV/RTV treatment
- Participation in a clinical trial with ATV at the time of or after initiation of ATV/RTV-based regimen
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT01236235
Start Date
January 1 2011
End Date
July 1 2013
Last Update
September 5 2013
Active Locations (53)
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1
Local Institution
Aachen, Germany, 52062
2
Local Institution
Berlin, Germany, 10243
3
Local Institution
Berlin, Germany, 10551
4
Local Institution
Berlin, Germany, 10777