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

Study Overview
=================
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.

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

Conditions
-----------------
Human Immunodeficiency Virus

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected Participants<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tablets, Infection, Non Nucleoside Reverse Transcriptase Inhibitor, Tolerability, Viral load, Human immunodeficiency Virus, Effectiveness, Treatment-naïve