Study on the Usage, Dosing, Tolerability, and Effectiveness of Kaletra Tablet - Full Text View

Purpose

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
Human Immunodeficiency Virus


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort

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 AbbVie ( AbbVie (prior sponsor, Abbott) ):

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').


Enrollment:	3049
Study Start Date:	August 2006
Study Completion Date:	January 2016
Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts
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).

Groups/Cohorts

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).

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.

Eligibility


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

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: 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
Study First Received:	February 26, 2010
Results First Received:	January 18, 2017
Last Updated:	May 18, 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

ClinicalTrials.gov processed this record on June 22, 2017