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

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT01097655
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

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 Timeline

• Study Start: 2006-08
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-02
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2017-01-18
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-18
• Last Update Submitted: 2017-05-18
• Results First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3049

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Absolute Cluster of Differentiation 4 (CD4) Cell Count	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	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.