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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097655
• Other study ID #: P06-131
• Status: Completed
• Phase: N/A
• First received: February 26, 2010
• Last updated: May 18, 2017
• Start date: August 2006
• Est. completion date: January 2016

Study information

• Verified date: May 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3049
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Veeda Clinical Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 (?GT), 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
Other	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 ?GT, 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
Primary	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
Primary	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

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