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

Use of KALETRA® Tablets in Adult HIV-infected Patients: Data From the Multicenter Star/Stella Cohort

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 3049

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count	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.	Baseline (Week 0) to Week 144
Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load	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.	Baseline (Week 0) to Week 144

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Adverse Events (Weeks 0-144), Per Event	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').	Weeks 0 to 144
Prevalence of Adverse Events (Weeks 0-144), Per Participant	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').	Weeks 0 to 144

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborators: Veeda Clinical Research
• Investigators: Study Director: Sandra Bloch, MD, AbbVie Deutschland GmbH & Co. KG, Medical Department

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 26, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 2, 2010

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Infection; Tolerability; Effectiveness; Viral load; Tablets; Treatment-naïve; Non Nucleoside Reverse Transcriptase Inhibitor; Human immunodeficiency Virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: P06-131