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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3049 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Human Immunodeficiency Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No