Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting

Completed

• Conditions: HIV

• Registration Number: NCT01236235
• Lead Sponsor: Bristol-Myers Squibb

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 - July 2010) until July 2013 at the latest (if no ATV discontinuation, or death, or lost to follow up).

Non probability sample:

* Specialized HIV management centers will be contacted in order to recruit about 15-20 sites per country.

* Each site will have to enroll an average of 8-12 consecutive patients (min:5; max:30) fulfilling the inclusion/exclusion criteria.

Study Timeline

• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-07
• Study Start: 2011-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients remaining on ATV-based treatment over time	Up to 5.5 years	Every 6 months from ATV initiation till July 2013 at the latest (maximum follow-up time up to 5.5 years)

Secondary Outcome Measures

Name	Time	Method
Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL)	Every 6 months up to 5.5 years
Mean change in Cluster of differentiation 4 (CD4) cell count	Every 6 months up to 5.5 years
Adverse events (AEs) related to ATV	Every 6 months up to 5.5 years
Time to discontinuation of ATV	Every 6 months up to 5.5 years
Reasons for ATV discontinuation	Every 6 months up to 5.5 years
Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL	Every 6 months up to 5.5 years
Mean change in HIV-1 RNA	Every 6 months up to 5.5 years
Lipid profile	Every 6 months up to 5.5 years

Trial Locations

Locations (1)

Local Institution; 🇪🇸 Zaragoza, Spain