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| Name | Class |
|---|---|
| PharmaNet | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARV-naïve HIV patients initiated on ATV/RTV-based therapy | Anti-retroviral (ARV)-naïve HIV patients initiated on ATV/RTV-based therapy between 2008-2010 One cohort being observed for 3 different countries |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients attending HIV specialized management centers will be considered.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Aachen | 52062 | Germany | |||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26899539 | Derived | Teofilo E, Rocha-Pereira N, Kuhlmann B, Antela A, Knechten H, Santos J, Jimenez-Exposito MJ; REMAIN study group. Long-Term Efficacy, Tolerability, and Renal Safety of Atazanavir/Ritonavir-based Antiretroviral Therapy in a Cohort of Treatment-Naive Patients with HIV-1 Infection: the REMAIN Study. HIV Clin Trials. 2016 Feb;17(1):17-28. doi: 10.1080/15284336.2015.1112494. |
| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
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| 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 |
| Berlin |
| 10243 |
| Germany |
| Local Institution | Berlin | 10551 | Germany |
| Local Institution | Berlin | 10777 | Germany |
| Local Institution | Berlin | 13347 | Germany |
| Local Institution | Berlin | 13353 | Germany |
| Local Institution | Berlin | 14057 | Germany |
| Local Institution | Düsseldorf | 40237 | Germany |
| Local Institution | Freiburg im Breisgau | 79106 | Germany |
| Local Institution | Hamburg | 20099 | Germany |
| Local Institution | Hamburg | 20146 | Germany |
| Local Institution | Hanover | 30159 | Germany |
| Local Institution | Mannheim | 68161 | Germany |
| Local Institution | München | 80801 | Germany |
| Local Institution | Regensburg | 93053 | Germany |
| Local Institution | Stuttgart | 70197 | Germany |
| Local Institution | Aveiro | 3814501 | Portugal |
| Local Institution | Barreiro | 2830094 | Portugal |
| Local Institution | Lisbon | 1150199 | Portugal |
| Local Institution | Lisbon | 1169050 | Portugal |
| Local Institution | Lisbon | 1349019 | Portugal |
| Local Institution | Lisbon | 1649028 | Portugal |
| Local Institution | Portimão | 8500338 | Portugal |
| Local Institution | Porto | 4099001 | Portugal |
| Local Institution | Porto | 4369004 | Portugal |
| Local Institution | Pragal | 2801951 | Portugal |
| Local Institution | Santarém | 2005177 | Portugal |
| Local Institution | São Martinho do Bispo | 3041801 | Portugal |
| Local Institution | Vila Nova de Gaia | 4434502 | Portugal |
| Local Institution | Alcorcón | 28922 | Spain |
| Local Institution | Badalona | 08916 | Spain |
| Local Institution | Barcelona | 08003 | Spain |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Barcelona | 08041 | Spain |
| Local Institution | Granada | 18014 | Spain |
| Local Institution | Granollers | 08402 | Spain |
| Local Institution | Guadalajara | 19002 | Spain |
| Local Institution | Jerez de la Frontera | 11407 | Spain |
| Local Institution | Leganés | 28911 | Spain |
| Local Institution | Logroño | 26006 | Spain |
| Local Institution | Madrid | 28006 | Spain |
| Local Institution | Madrid | 28034 | Spain |
| Local Institution | Marbella | 29603 | Spain |
| Local Institution | Mataró | 08304 | Spain |
| Local Institution | Málaga | 29010 | Spain |
| Local Institution | Móstoles | 28935 | Spain |
| Local Institution | Santiago de Compostela | 15706 | Spain |
| Local Institution | Seville | 41013 | Spain |
| Local Institution | Tarragona | 43003 | Spain |
| Local Institution | Valencia | 46014 | Spain |
| Local Institution | Valencia | 46015 | Spain |
| Local Institution | Valencia | 46026 | Spain |
| Local Institution | Zaragoza | 50009 | Spain |
| For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm | View source |