HIV-1 Patients Clinical Trial
Official title:
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
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.
As this study is observational in nature, subject follow-up was not specified by the protocol but was left to the judgment of each physician within the 18 months period, which defines the survey for each participant. For indicative purposes, follow-up of each participant should enable approximately 7 visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following inclusion (usually at the end of the first treatment month) and apart from visits required because of intercurrent events. Participant visits were assigned as follows: Baseline/Day 0 (start of lopinavir/ritonavir treatment), Month 1 (day 1 to day 45), Month 3 (day 46 to day 136), Month 6 (day 137 to day 228), Month 9 (day 229 to day 319), Month 12 (day 320 to day 410), Month 15 (day 411 to day 501), Month 18 (day 502 to day 593). Each participant is planned to be observed during his/her lopinavir/ritonavir capsule containing treatment regimen for a maximum period of 18 months, and each participant is planned to be observed during his/her lopinavir/ritonavir tablet containing treatment regimen for a maximum period of 9 months. ;
Time Perspective: Prospective