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Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use

NCT01379703 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2288

Last updated 2011-10-17

Study results available
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Summary

KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients.

The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries.

The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.

Conditions

  • HIV-1 Patients

Sponsors & Collaborators

Principal Investigators

  • Maja Hojnik, MD, PhD · Abbott International

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Czechia
  • Georgia
  • Israel
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Slovenia
  • Ukraine

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379703 on ClinicalTrials.gov