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

AbbVie

Status: Completed

Conditions: Human Immunodeficiency Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT01097655

P06-131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,049 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,049 participants in 1 patient group

HIV-infected Participants

Description:

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).