Skip to main content
OpenTrials
Completed

NCT Number: NCT01236235

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Aachen, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Time to discontinuation of ATV

    Time frame: Every 6 months up to 5.5 years

  2. Reasons for ATV discontinuation

    Time frame: Every 6 months up to 5.5 years

  3. Percent of patients with HIV-1 ribonucleic acid (RNA) < 50 and < 500 c/mL

    Time frame: Every 6 months up to 5.5 years

  4. Mean change in HIV-1 RNA

    Time frame: Every 6 months up to 5.5 years

  5. Time to viral failure (HIV-1 RNA ≥ 50 and ≥ 500 c/mL)

    Time frame: Every 6 months up to 5.5 years

  6. Mean change in Cluster of differentiation 4 (CD4) cell count

    Time frame: Every 6 months up to 5.5 years

  7. Adverse events (AEs) related to ATV

    Time frame: Every 6 months up to 5.5 years

  8. Lipid profile

    Time frame: Every 6 months up to 5.5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • PharmaNet

Registry information

Official study 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

Acronym: REMAIN

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 8, 2010
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.