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

HIV Clinical Trial

— REMAIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236235
• Other study ID #: AI424-401
• Status: Completed
• Phase: N/A
• First received: November 5, 2010
• Last updated: September 4, 2013
• Start date: January 2011
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections

Locations

Country	Name	City	State
Germany	Local Institution	Aachen
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Dusseldorf
Germany	Local Institution	Freiburg
Germany	Local Institution	Hamburg
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Mannheim
Germany	Local Institution	Munchen
Germany	Local Institution	Regensburg
Germany	Local Institution	Stuttgart
Portugal	Local Institution	Aveiro
Portugal	Local Institution	Barreiro
Portugal	Local Institution	Lisboa
Portugal	Local Institution	Lisboa
Portugal	Local Institution	Lisboa
Portugal	Local Institution	Lisboa
Portugal	Local Institution	Portimao
Portugal	Local Institution	Porto
Portugal	Local Institution	Porto
Portugal	Local Institution	Pragal
Portugal	Local Institution	Santarem
Portugal	Local Institution	Sao Martinho do Bispo
Portugal	Local Institution	Vila Nova de Gaia
Spain	Local Institution	Alcorcon
Spain	Local Institution	Badalona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Granada
Spain	Local Institution	Granollers
Spain	Local Institution	Guadalajara
Spain	Local Institution	Jerez de la Frontera
Spain	Local Institution	Leganes
Spain	Local Institution	Logrono
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Malaga
Spain	Local Institution	Marbella
Spain	Local Institution	Mataro
Spain	Local Institution	Mostoles
Spain	Local Institution	Santiago de Compostela
Spain	Local Institution	Sevilla
Spain	Local Institution	Tarragona
Spain	Local Institution	Valencia
Spain	Local Institution	Valencia
Spain	Local Institution	Valencia
Spain	Local Institution	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	PharmaNet

Countries where clinical trial is conducted

Germany,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to discontinuation of ATV		Every 6 months up to 5.5 years	No
Secondary	Reasons for ATV discontinuation		Every 6 months up to 5.5 years	Yes
Secondary	Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL		Every 6 months up to 5.5 years	No
Secondary	Mean change in HIV-1 RNA		Every 6 months up to 5.5 years	No
Secondary	Time to viral failure (HIV-1 RNA = 50 and = 500 c/mL)		Every 6 months up to 5.5 years	No
Secondary	Mean change in Cluster of differentiation 4 (CD4) cell count		Every 6 months up to 5.5 years	No
Secondary	Adverse events (AEs) related to ATV		Every 6 months up to 5.5 years	Yes
Secondary	Lipid profile		Every 6 months up to 5.5 years	Yes

External Links

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