Kaletra in Combination With Antiretroviral Agents

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

502 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to investigate the tolerability of Kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (INIs), C-C chemokine receptor type 5 (CCR5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with Kaletra.

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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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Human Immunodeficiency Virus (HIV)-Infected Participants

HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 18years of age
* Written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the KALETRA® post marketing observational study)
* HIV-1 infection
* Patients treated with KALETRA®, independent from their participation in this study
* Patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study

Exclusion Criteria

* Hypersensitivity against Kaletra or other ingredients or INIs or NNRTIs or CCR5 antagonists
* Severe liver insufficiency
* No concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or St. John's wort

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No