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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01236235

Acronym

REMAIN

Enrollment

525

Registered

2010-11-08

Start date

2011-01-31

Completion date

2013-07-31

Last updated

2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

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.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients remaining on ATV-based treatment over time	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)

Secondary

Measure	Time frame
Reasons for ATV discontinuation	Every 6 months up to 5.5 years
Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL	Every 6 months up to 5.5 years
Mean change in HIV-1 RNA	Every 6 months up to 5.5 years
Time to discontinuation of ATV	Every 6 months up to 5.5 years
Mean change in Cluster of differentiation 4 (CD4) cell count	Every 6 months up to 5.5 years
Adverse events (AEs) related to ATV	Every 6 months up to 5.5 years
Lipid profile	Every 6 months up to 5.5 years
Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL)	Every 6 months up to 5.5 years

Countries

Germany, Portugal, Spain

Outcome results