Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting (REMAIN)
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|ClinicalTrials.gov Identifier: NCT01236235|
Recruitment Status : Completed
First Posted : November 8, 2010
Last Update Posted : September 5, 2013
|Condition or disease|
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|
|Actual Enrollment :||525 participants|
|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|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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
- Proportion of patients remaining on ATV-based treatment over time [ Time Frame: Up to 5.5 years ]Every 6 months from ATV initiation till July 2013 at the latest (maximum follow-up time up to 5.5 years)
- Time to discontinuation of ATV [ Time Frame: Every 6 months up to 5.5 years ]
- Reasons for ATV discontinuation [ Time Frame: Every 6 months up to 5.5 years ]
- Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL [ Time Frame: Every 6 months up to 5.5 years ]
- Mean change in HIV-1 RNA [ Time Frame: Every 6 months up to 5.5 years ]
- Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL) [ Time Frame: Every 6 months up to 5.5 years ]
- Mean change in Cluster of differentiation 4 (CD4) cell count [ Time Frame: Every 6 months up to 5.5 years ]
- Adverse events (AEs) related to ATV [ Time Frame: Every 6 months up to 5.5 years ]
- Lipid profile [ Time Frame: Every 6 months up to 5.5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236235
Show 53 Study Locations
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|