NCT01236235

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
525

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
3 countries

53 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

2.5 years

First QC Date

November 5, 2010

Last Update Submit

September 4, 2013

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending HIV specialized management centers will be considered.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (53)

Local Institution

Aachen, 52062, Germany

Location

Local Institution

Berlin, 10243, Germany

Location

Local Institution

Berlin, 10551, Germany

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Local Institution

Berlin, 10777, Germany

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Local Institution

Berlin, 13347, Germany

Location

Local Institution

Berlin, 13353, Germany

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Local Institution

Berlin, 14057, Germany

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Local Institution

Düsseldorf, 40237, Germany

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Local Institution

Freiburg im Breisgau, 79106, Germany

Location

Local Institution

Hamburg, 20099, Germany

Location

Local Institution

Hamburg, 20146, Germany

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Local Institution

Hanover, 30159, Germany

Location

Local Institution

Mannheim, 68161, Germany

Location

Local Institution

München, 80801, Germany

Location

Local Institution

Regensburg, 93053, Germany

Location

Local Institution

Stuttgart, 70197, Germany

Location

Local Institution

Aveiro, 3814501, Portugal

Location

Local Institution

Barreiro, 2830094, Portugal

Location

Local Institution

Lisbon, 1150199, Portugal

Location

Local Institution

Lisbon, 1169050, Portugal

Location

Local Institution

Lisbon, 1349019, Portugal

Location

Local Institution

Lisbon, 1649028, Portugal

Location

Local Institution

Portimão, 8500338, Portugal

Location

Local Institution

Porto, 4099001, Portugal

Location

Local Institution

Porto, 4369004, Portugal

Location

Local Institution

Pragal, 2801951, Portugal

Location

Local Institution

Santarém, 2005177, Portugal

Location

Local Institution

São Martinho do Bispo, 3041801, Portugal

Location

Local Institution

Vila Nova de Gaia, 4434502, Portugal

Location

Local Institution

Alcorcón, 28922, Spain

Location

Local Institution

Badalona, 08916, Spain

Location

Local Institution

Barcelona, 08003, Spain

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution

Barcelona, 08041, Spain

Location

Local Institution

Granada, 18014, Spain

Location

Local Institution

Granollers, 08402, Spain

Location

Local Institution

Guadalajara, 19002, Spain

Location

Local Institution

Jerez de la Frontera, 11407, Spain

Location

Local Institution

Leganés, 28911, Spain

Location

Local Institution

Logroño, 26006, Spain

Location

Local Institution

Madrid, 28006, Spain

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Local Institution

Madrid, 28034, Spain

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Local Institution

Marbella, 29603, Spain

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Local Institution

Mataró, 08304, Spain

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Local Institution

Málaga, 29010, Spain

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Local Institution

Móstoles, 28935, Spain

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Local Institution

Santiago de Compostela, 15706, Spain

Location

Local Institution

Seville, 41013, Spain

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Local Institution

Tarragona, 43003, Spain

Location

Local Institution

Valencia, 46014, Spain

Location

Local Institution

Valencia, 46015, Spain

Location

Local Institution

Valencia, 46026, Spain

Location

Local Institution

Zaragoza, 50009, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26899539DERIVED

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

November 8, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

DE(16)PT(13)ES(24)