Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection

Study Identifier
P12-760
CT.gov Identifier
NCT01328158
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
    N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Participants who were receiving Kaletra or who started Kaletra therapy during the registration period.
    Exclusion Criteria:
    * Participants with a history of hypersensitivity to any ingredient of this drug. * Participants who are undergoing treatment with any of the following drugs: pimozide, ergotamine tartrate, dihydroergotamine mesilate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, sildenafil citrate (Revatio), tadalafil (Adcirca), blonanserin, azelnidipine, rivaroxaban, voriconazole.

    Protocol Summary

    This study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug:

    1. Incidence and conditions of occurrence of adverse reactions in the clinical setting

    2. Factors that may affect the safety and effectiveness of Kaletra (QD)

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 57629
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 57630
    Hiroshima, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 57631
    Hokkaido, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 57628
    Kitakyushu-shi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 57638
    Kurashiki-shi, Japan
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 57634
    Kyoto, Japan
    Status
    Not applicable
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