Clinical trial NCT01236235: Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: PharmaNet
First posted: 2010-11-07
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending HIV specialized management centers will be considered.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients remaining on ATV-based treatment over time
timeFrame: Up to 5.5 years
Secondary outcomes:
measure: Time to discontinuation of ATV
timeFrame: Every 6 months up to 5.5 years
measure: Reasons for ATV discontinuation
timeFrame: Every 6 months up to 5.5 years
measure: Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL
timeFrame: Every 6 months up to 5.5 years
measure: Mean change in HIV-1 RNA
timeFrame: Every 6 months up to 5.5 years
measure: Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL)
timeFrame: Every 6 months up to 5.5 years
measure: Mean change in Cluster of differentiation 4 (CD4) cell count
timeFrame: Every 6 months up to 5.5 years
measure: Adverse events (AEs) related to ATV
timeFrame: Every 6 months up to 5.5 years
measure: Lipid profile
timeFrame: Every 6 months up to 5.5 years
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Dusseldorf
country: Germany
facility: Local Institution
city: Freiburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Regensburg
country: Germany
facility: Local Institution
city: Stuttgart
country: Germany
facility: Local Institution
city: Aveiro
country: Portugal
facility: Local Institution
city: Barreiro
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Lisboa
country: Portugal
facility: Local Institution
city: Portimao
country: Portugal
facility: Local Institution
city: Porto
country: Portugal
facility: Local Institution
city: Porto
country: Portugal
facility: Local Institution
city: Pragal
country: Portugal
facility: Local Institution
city: Santarem
country: Portugal
facility: Local Institution
city: Sao Martinho do Bispo
country: Portugal
facility: Local Institution
city: Vila Nova de Gaia
country: Portugal
facility: Local Institution
city: Alcorcon
country: Spain
facility: Local Institution
city: Badalona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Granada
country: Spain
facility: Local Institution
city: Granollers
country: Spain
facility: Local Institution
city: Guadalajara
country: Spain
facility: Local Institution
city: Jerez de la Frontera
country: Spain
facility: Local Institution
city: Leganes
country: Spain
facility: Local Institution
city: Logrono
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Marbella
country: Spain
facility: Local Institution
city: Mataro
country: Spain
facility: Local Institution
city: Mostoles
country: Spain
facility: Local Institution
city: Santiago de Compostela
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Tarragona
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Zaragoza
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.