Kaletra in Combination With Antiretroviral Agents

Study Identifier
P11-021
CT.gov Identifier
NCT01076179
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Human Immunodeficiency Virus (HIV)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    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

    Protocol Summary

    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.

    Study Locations

    No locations found.