Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01097655

Recruitment Status : Completed

First Posted : April 2, 2010

Results First Posted : May 23, 2017

Last Update Posted : May 23, 2017

Sponsor:

Collaborator:

Veeda Clinical Research

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description

Brief Summary:

The objective of this study is to observe and collect data on the usage, dosing, tolerability, and effectiveness of Kaletra (lopinavir/ritonavir) tablets in human immunodeficiency virus (HIV)-infected patients. In some patients, the study is to show the impact on tolerability of changing therapy to Kaletra tablets from other regimens.

Condition or disease
Human Immunodeficiency Virus

Detailed Description:

This study was designed as a non-interventional observational study. Kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Study Design


Study Type :	Observational
Actual Enrollment :	3049 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort
Study Start Date :	August 2006
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lopinavir

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
HIV-infected Participants HIV-infected participants starting with Kaletra tablets. Participants included 3 subgroups: antiretroviral therapy (ART) treatment-naïve participants starting with Kaletra tablets participants receiving their first protease inhibitor (PI)-containing regimen (apart from Kaletra) pretreated with any non nucleoside reverse transcriptase inhibitor (NNRTI)-containing or nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen participants pretreated with a PI-containing regimen (apart from Kaletra).

Group/Cohort

HIV-infected Participants

HIV-infected participants starting with Kaletra tablets.

Participants included 3 subgroups:

antiretroviral therapy (ART) treatment-naïve participants starting with Kaletra tablets
participants receiving their first protease inhibitor (PI)-containing regimen (apart from Kaletra) pretreated with any non nucleoside reverse transcriptase inhibitor (NNRTI)-containing or nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen
participants pretreated with a PI-containing regimen (apart from Kaletra).

Outcome Measures

Primary Outcome Measures :

Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count [ Time Frame: Baseline (Week 0) to Week 144 ]
Changes in participants' CD4 cell counts were assessed by measuring the change from Baseline in the number of CD4 cells at scheduled visits planned as part of routine care.
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load [ Time Frame: Baseline (Week 0) to Week 144 ]
Changes in participants' HIV-1 RNA viral load were assessed by measuring the change from Baseline at scheduled visits planned as part of routine care.

Other Outcome Measures:

Prevalence of Adverse Events (Weeks 0-144), Per Event [ Time Frame: Weeks 0 to 144 ]
Percentage of overall number of adverse events experienced during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the electronic case report form (eCRF). The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low high density lipoprotein (HDL) cholesterol, high low density lipoprotein (LDL) cholesterol, hyperglycemia, hyperbilirubinemia, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gamma glutamyl transferase (γGT), elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').
Prevalence of Adverse Events (Weeks 0-144), Per Participant [ Time Frame: Weeks 0 to 144 ]
Percentage of participants who experienced at least 1 adverse event during Weeks 0-144 by adverse event type. Doctors asked participants for adverse events, grouped them into categories given in the eCRF. The list of adverse events included in the eCRF were hypertriglyceridemia, hypercholesterolemia, low HDL cholesterol, high LDL cholesterol, hyperglycemia, hyperbilirubinemia, elevated AST, elevated ALT, elevated γGT, elevated alkaline phosphatase, stomatitis, nausea, vomiting, diarrhea, abdominal pain, mood disorder, neurocerebellar disorder, neurocontrol disorder, headache, fatigue, fever, other (listed as 'not specified').

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Community sample; HIV-infected patients
For Belgium: AIDS references centers (probability sample)

Criteria

Inclusion Criteria:

Patients with HIV infection
Patients that will be treated with Kaletra tablets independent from their participation in this study

Exclusion Criteria:

Hypersensitivity against Kaletra or other ingredients
Severe liver insufficiency
No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and St. John's wort
Patients who received more than 1 protease inhibitor during their therapy history

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097655

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Veeda Clinical Research

Investigators


Study Director:	Sandra Bloch, MD	AbbVie Deutschland GmbH & Co. KG, Medical Department

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


Responsible Party:	AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:	NCT01097655 History of Changes
Other Study ID Numbers:	P06-131
First Posted:	April 2, 2010 Key Record Dates
Results First Posted:	May 23, 2017
Last Update Posted:	May 23, 2017
Last Verified:	May 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):


Tablets Infection Non Nucleoside Reverse Transcriptase Inhibitor Tolerability	Viral load Human immunodeficiency Virus Effectiveness Treatment-naïve

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Reverse Transcriptase Inhibitors	Lopinavir Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

To Top