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

Completed

Conditions: HIV-1 Patients

Registration Number: NCT01379703

Lead Sponsor: Abbott

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2288

Inclusion Criteria

Patients infected by HIV-1 infection who are either:

Antiretroviral treatment (ART) naive or
Had failed or had been intolerant to one previous combined antiretroviral treatment (cART), not including a Protease inhibitor (PI) (first-line pretreated without a Protease inhibitor) or
Had failed or had been intolerant to one previous antiretroviral treatment ART, including one Protease inhibitor (first-line pretreated with a Protease Inhibitor).

A ritonavir-boosted Protease inhibitor PI is considered as treatment with one Protease inhibitor PI.

Exclusion Criteria

Treatment with drugs at risk for interactions with lopinavir/ritonavir
Uncontrolled AIDS defining disease
Two or more previous Protease inhibitors (PIs)
Participation in another study or clinical trial

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CD4 Count	Baseline	CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.
Changes in CD4 Count	Baseline to 18 months	Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.
Viral Load	18 months	Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.
Laboratory Parameter Blood Glucose	Baseline, 9 months, 18 months	Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Laboratory Parameter Transaminases	Baseline, 9 months, 18 months	Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.
Laboratory Parameter Lipids	Baseline, 9 months, 18 months	A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.

Secondary Outcome Measures

Name	Time	Method
Reasons for Discontinuation of Lopinavir/Ritonavir	18 months	For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Compliance With Lopinavir/Ritonavir	18 months	Participants reported whether they had missed any doses of their antiretroviral treatment.
Adverse Events Observed on Treatment With Lopinavir/Ritonavir.	18 months	Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment. All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the "Reported Adverse Events" section of this record.

Trial Locations

Locations (103): Site Ref # / Investigator 57102
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Brno, Czech Republic
Site Ref # / Investigator 57054
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Ceske Budejovice, Czech Republic
Site Ref # / Investigator 57055
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Hradec Kralove, Czech Republic
Site Ref # / Investigator 57056
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Ostrava, Czech Republic
Site Ref # / Investigator 57052
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Plzen, Czech Republic
Site Ref # / Investigator 5344
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Prague 8, Czech Republic
Site Ref # / Investigator 57053
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Usti nad Labem, Czech Republic
Site Ref # / Investigator 7576
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Tbilisi, Georgia
Site Ref # / Investigator 57050
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Beer-Sheva, Israel
Site Ref # / Investigator 57048
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Haifa, Israel
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Site Ref # / Investigator 57102
🇨🇿Brno, Czech Republic