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

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.

Study Overview

• Status: Completed
• Conditions: HIV

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
• Enrollment (Actual): 525

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending HIV specialized management centers will be considered.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: PharmaNet

Publications and helpful links

General Publications

• 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.

Helpful Links

• BMS Clinical Trials Disclosure
• For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Estimate): September 5, 2013
• Last Update Submitted That Met QC Criteria: September 4, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: AI424-401