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

This study has been completed.
Sponsor:
Collaborator:
PharmaNet
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01236235
First received: November 5, 2010
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.


Condition
HIV

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of patients remaining on ATV-based treatment over time [ Time Frame: Up to 5.5 years ] [ Designated as safety issue: No ]
    Every 6 months from ATV initiation till July 2013 at the latest (maximum follow-up time up to 5.5 years)


Secondary Outcome Measures:
  • Time to discontinuation of ATV [ Time Frame: Every 6 months up to 5.5 years ] [ Designated as safety issue: No ]
  • Reasons for ATV discontinuation [ Time Frame: Every 6 months up to 5.5 years ] [ Designated as safety issue: Yes ]
  • Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL [ Time Frame: Every 6 months up to 5.5 years ] [ Designated as safety issue: No ]
  • Mean change in HIV-1 RNA [ Time Frame: Every 6 months up to 5.5 years ] [ Designated as safety issue: No ]
  • Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL) [ Time Frame: Every 6 months up to 5.5 years ] [ Designated as safety issue: No ]
  • Mean change in Cluster of differentiation 4 (CD4) cell count [ Time Frame: Every 6 months up to 5.5 years ] [ Designated as safety issue: No ]
  • Adverse events (AEs) related to ATV [ Time Frame: Every 6 months up to 5.5 years ] [ Designated as safety issue: Yes ]
  • Lipid profile [ Time Frame: Every 6 months up to 5.5 years ] [ Designated as safety issue: Yes ]

Enrollment: 525
Study Start Date: January 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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


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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients attending HIV specialized management centers will be considered.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236235

  Hide Study Locations
Locations
Germany
Local Institution
Aachen, Germany, 52062
Local Institution
Berlin, Germany, 14057
Local Institution
Berlin, Germany, 10551
Local Institution
Berlin, Germany, 10777
Local Institution
Berlin, Germany, 13347
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Berlin, Germany, 13353
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Berlin, Germany, 10243
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Dusseldorf, Germany, 40237
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Freiburg, Germany, 79106
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Hamburg, Germany, 20146
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Hamburg, Germany, 20099
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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
Portugal
Local Institution
Aveiro, Portugal, 3814501
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Barreiro, Portugal, 2830094
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Lisboa, Portugal, 1169050
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Lisboa, Portugal, 1349019
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Lisboa, Portugal, 1150199
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Lisboa, Portugal, 1649028
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Portimao, Portugal, 8500338
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Porto, Portugal, 4369004
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Porto, Portugal, 4099001
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Pragal, Portugal, 2801951
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Santarem, Portugal, 2005177
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Sao Martinho do Bispo, Portugal, 3041801
Local Institution
Vila Nova de Gaia, Portugal, 4434502
Spain
Local Institution
Alcorcon, Spain, 28922
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Badalona, Spain, 08916
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Barcelona, Spain, 08035
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Barcelona, Spain, 08041
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Barcelona, Spain, 08003
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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
Local Institution
Valencia, Spain, 46026
Local Institution
Valencia, Spain, 46014
Local Institution
Valencia, Spain, 46015
Local Institution
Zaragoza, Spain, 50009
Sponsors and Collaborators
Bristol-Myers Squibb
PharmaNet
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01236235     History of Changes
Other Study ID Numbers: AI424-401
Study First Received: November 5, 2010
Last Updated: September 4, 2013
Health Authority: Spain: Ministry of Health

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
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014