MedDataX Logo

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

NCT ID: NCT01236235

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

525 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PharmaNet

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution

Aachen, , Germany

Site Status

Local Institution

Berlin, , Germany

Site Status

Local Institution

Berlin, , Germany

Site Status

Local Institution

Berlin, , Germany

Site Status

Local Institution

Berlin, , Germany

Site Status

Local Institution

Berlin, , Germany

Site Status

Local Institution

Berlin, , Germany

Site Status

Local Institution

Düsseldorf, , Germany

Site Status

Local Institution

Freiburg im Breisgau, , Germany

Site Status

Local Institution

Hamburg, , Germany

Site Status

Local Institution

Hamburg, , Germany

Site Status

Local Institution

Hanover, , Germany

Site Status

Local Institution

Mannheim, , Germany

Site Status

Local Institution

München, , Germany

Site Status

Local Institution

Regensburg, , Germany

Site Status

Local Institution

Stuttgart, , Germany

Site Status

Local Institution

Aveiro, , Portugal

Site Status

Local Institution

Barreiro, , Portugal

Site Status

Local Institution

Lisbon, , Portugal

Site Status

Local Institution

Lisbon, , Portugal

Site Status

Local Institution

Lisbon, , Portugal

Site Status

Local Institution

Lisbon, , Portugal

Site Status

Local Institution

Portimão, , Portugal

Site Status

Local Institution

Porto, , Portugal

Site Status

Local Institution

Porto, , Portugal

Site Status

Local Institution

Pragal, , Portugal

Site Status

Local Institution

Santarém, , Portugal

Site Status

Local Institution

São Martinho do Bispo, , Portugal

Site Status

Local Institution

Vila Nova de Gaia, , Portugal

Site Status

Local Institution

Alcorcón, , Spain

Site Status

Local Institution

Badalona, , Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Barcelona, , Spain

Site Status

Local Institution

Granada, , Spain

Site Status

Local Institution

Granollers, , Spain

Site Status

Local Institution

Guadalajara, , Spain

Site Status

Local Institution

Jerez de la Frontera, , Spain

Site Status

Local Institution

Leganés, , Spain

Site Status

Local Institution

Logroño, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Marbella, , Spain

Site Status

Local Institution

Mataró, , Spain

Site Status

Local Institution

Málaga, , Spain

Site Status

Local Institution

Móstoles, , Spain

Site Status

Local Institution

Santiago de Compostela, , Spain

Site Status

Local Institution

Seville, , Spain

Site Status

Local Institution

Tarragona, , Spain

Site Status

Local Institution

Valencia, , Spain

Site Status

Local Institution

Valencia, , Spain

Site Status

Local Institution

Valencia, , Spain

Site Status

Local Institution

Zaragoza, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany Portugal Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26899539 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bms.com/clinical_trials/Pages/home.aspx

BMS Clinical Trials Disclosure

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AI424-401

Identifier Type: -

Identifier Source: org_study_id