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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Non Comparative Observational Study to Describe the Duration and Outcome of Treatment in Therapy naïve HIV Positive Patients Initiated on Atazanavir (ATV)/ Ritonavir (RTV)-Based Highly Active Antiretroviral Therapy (HAART) Regimens

Conditions
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HIV

Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ARV-naïve HIV patients initiated on ATV/RTV-based therapy<br>Anti-retroviral (ARV)-naïve HIV patients initiated on ATV/RTV-based therapy between 2008-2010 One cohort being observed for 3 different countries | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Lipid profile |  | Every 6 months up to 5.5 years |