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

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ClinicalTrials.gov Identifier: NCT01236235
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):
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.

Condition or disease

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 Type : Observational
Actual Enrollment : 525 participants
Observational Model: Cohort
Official Title: 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
Study Start Date : January 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Proportion of patients remaining on ATV-based treatment over time [ Time Frame: 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 :
  1. Time to discontinuation of ATV [ Time Frame: Every 6 months up to 5.5 years ]
  2. Reasons for ATV discontinuation [ Time Frame: Every 6 months up to 5.5 years ]
  3. Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL [ Time Frame: Every 6 months up to 5.5 years ]
  4. Mean change in HIV-1 RNA [ Time Frame: Every 6 months up to 5.5 years ]
  5. Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL) [ Time Frame: Every 6 months up to 5.5 years ]
  6. Mean change in Cluster of differentiation 4 (CD4) cell count [ Time Frame: Every 6 months up to 5.5 years ]
  7. Adverse events (AEs) related to ATV [ Time Frame: Every 6 months up to 5.5 years ]
  8. Lipid profile [ Time Frame: Every 6 months up to 5.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients attending HIV specialized management centers will be considered.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236235

  Hide Study Locations
Local Institution
Aachen, Germany, 52062
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Berlin, Germany, 10243
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Berlin, Germany, 10551
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Berlin, Germany, 10777
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Berlin, Germany, 13347
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Berlin, Germany, 13353
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Berlin, Germany, 14057
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Dusseldorf, Germany, 40237
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Freiburg, Germany, 79106
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Hamburg, Germany, 20099
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Hamburg, Germany, 20146
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Hannover, Germany, 30159
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Mannheim, Germany, 68161
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Munchen, Germany, 80801
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Regensburg, Germany, 93053
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Stuttgart, Germany, 70197
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Aveiro, Portugal, 3814501
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Barreiro, Portugal, 2830094
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Lisboa, Portugal, 1150199
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Lisboa, Portugal, 1169050
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Lisboa, Portugal, 1349019
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Lisboa, Portugal, 1649028
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Portimao, Portugal, 8500338
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Porto, Portugal, 4099001
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Porto, Portugal, 4369004
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Pragal, Portugal, 2801951
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Santarem, Portugal, 2005177
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Sao Martinho do Bispo, Portugal, 3041801
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Vila Nova de Gaia, Portugal, 4434502
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Alcorcon, Spain, 28922
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Badalona, Spain, 08916
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Barcelona, Spain, 08003
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Barcelona, Spain, 08035
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Barcelona, Spain, 08041
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Granada, Spain, 18014
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Granollers, Spain, 08402
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Guadalajara, Spain, 19002
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Jerez de la Frontera, Spain, 11407
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Leganes, Spain, 28911
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Logrono, Spain, 26006
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Madrid, Spain, 28006
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Madrid, Spain, 28034
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Malaga, Spain, 29010
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Marbella, Spain, 29603
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Mataro, Spain, 08304
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Mostoles, Spain, 28935
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Santiago de Compostela, Spain, 15706
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Sevilla, Spain, 41013
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Tarragona, Spain, 43003
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Valencia, Spain, 46014
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Valencia, Spain, 46015
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Valencia, Spain, 46026
Local Institution
Zaragoza, Spain, 50009
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01236235     History of Changes
Other Study ID Numbers: AI424-401
First Posted: November 8, 2010    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents