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

Purpose

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.

Condition
HIV-1 Patients


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

CD4 Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 1 month ] [ Designated as safety issue: No ]
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.
Changes in CD4 Count [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
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.
Changes in CD4 Count [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
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.
Changes in CD4 Count [ Time Frame: Baseline to 9 months ] [ Designated as safety issue: No ]
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.
Changes in CD4 Count [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
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.
Changes in CD4 Count [ Time Frame: Baseline to 15 months ] [ Designated as safety issue: No ]
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.
Changes in CD4 Count [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.
Viral Load [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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.
Viral Load [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Viral Load [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Viral Load [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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.
Viral Load [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Viral Load [ Time Frame: 15 months ] [ Designated as safety issue: No ]
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.
Viral Load [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 9 months, 18 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 9 months, 18 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 9 months, 18 months ] [ Designated as safety issue: No ]
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:

Reasons for Discontinuation of Lopinavir/Ritonavir [ Time Frame: 9 months ] [ Designated as safety issue: No ]
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Reasons for Discontinuation of Lopinavir/Ritonavir [ Time Frame: 18 months ] [ Designated as safety issue: No ]
For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.
Compliance With Lopinavir/Ritonavir [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Participants reported whether they had missed doses of their antiretroviral treatment.
Compliance With Lopinavir/Ritonavir [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Participants reported whether they had missed any doses of their antiretroviral treatment.
Adverse Events Observed on Treatment With Lopinavir/Ritonavir. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
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.


Enrollment:	2288
Study Start Date:	February 2004
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Single patients group Single HIV-1 infected patients group

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.

Eligibility


Ages Eligible for Study:	2 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

KaleEAST is non-interventional, observational study in which Kaletra® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regard to dose, population and indication.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379703

Show 103 Study Locations

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Maja Hojnik, MD, PhD	Abbott International

More Information


Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01379703 History of Changes
Other Study ID Numbers:	PMOS-EAST-04-1
Study First Received:	June 22, 2011
Results First Received:	August 9, 2011
Last Updated:	October 10, 2011
Health Authority:	Romania: Ethics Committee Romania: National Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Serbia: Ethics Committee Israel: Ethics Commission Israel: Ministry of Health Slovenia: Ethics Committee Slovak Republic: Ethics Committee Czech Republic: State Institute for Drug Control Latvia: Institutional Review Board Latvia: State Agency of Medicines Lithuania: Bioethics Committee Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Abbott:


HIV-1 infected patients Protease inhibitor Kaletra®

Additional relevant MeSH terms:


Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents	Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016

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