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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

November 5, 2010
September 4, 2013
January 2011
July 2013   (final data collection date for primary outcome measure)
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)
Proportion of patients remaining on ATV-based treatment over time [ Time Frame: Every 6 months from ATV initiation ] [ Designated as safety issue: No ]
Every 6 months from ATV initiation until July 2012 at the latest (maximum follow-up time up to 4.5 years).
Complete list of historical versions of study NCT01236235 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to discontinuation of ATV [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Reasons for ATV discontinuation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Percent of patients with HIV-1 RNA < 50 and < 500 c/mL [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Mean change in HIV-1 RNA [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Mean change in CD4 cell count [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • AEs related to ATV [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Lipid profile [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
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

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:

  • 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.
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

Patients attending HIV specialized management centers will be considered.

HIV
Not Provided
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

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
525
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Portugal,   Spain
 
NCT01236235
AI424-401
No
Bristol-Myers Squibb
Bristol-Myers Squibb
PharmaNet
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP