Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 4:13 PM
Study NCT ID:
NCT01236235
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2010-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMAIN
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: