Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
Study NCT ID:
NCT01379703
Status:
COMPLETED
Last Update Posted:
2011-10-17
First Post:
2011-06-22
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
Sponsor:
Abbott
Organization:
Study Overview
Official Title:
Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KaleEAST
Brief 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.
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: