Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets)

Study Identifier
P12-752
CT.gov Identifier
NCT01383005
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Human Immunodeficiency Virus (HIV)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Men or women aged 18 years or older, HIV-infected. 2. Patients who were under LPV/r Highly Active Anti-Retroviral Therapy (HAART) for 3 to 24 months before study visit: Cohort 1: patients on LPV/r QD since they started the LPV/r regimen and who were naïve to protease inhibitor (PI) therapy.\* Cohort 2: patients who previously started on LPV/r BID (maximum of 24 months before study) and switched to LPV/r QD (at least 3 months before the study visit).\* 3. Patients who were able to complete questionnaires by themselves. 4. Patients who signed/dated informed consent to participate in the study. * NOTE: Patients who were taking LPV/r QD should have had no more than 3 protease inhibitor mutations by the time the treatment with this LPV/r dosing was initiated.
    Exclusion Criteria:
    1. Patients who were on LPV/r monotherapy or bi-therapy or on BID dosing at time of study visit. 2. Patients who were using another LPV/r formulation different from 200/50 LPV/r mg tablets. 3. Patients who were participating in any other clinical trial or postmarketing observational study (PMOS). 4. Patients who were unable to read and/or write. 5. Patients who were under treatment interruption. Patients who have stopped LPV-therapy for more than 3 months in the 12 months preceding study visit.

    Protocol Summary

    Both twice-a-day (BID) and once-a-day (QD) dosing are approved in Europe for the protease inhibitor lopinavir/ritonavir (LPV/r; Kaletra®).

    Since once-a-day dosing is actually a driver for human immunodeficiency virus (HIV)-infected patients to request a specific antiretroviral, the aim of this study is to assess both patient's perception of and adherence to Kaletra once-a-day, as well as with which factors they are related.

    Study Locations

    Location
    Status
    Location
    Site Ref # / Investigator 52274
    A Coruña, Spain, 15006
    Status
    Not applicable
    Location
    Site Ref # / Investigator 52363
    Barakaldo, Spain, 48903
    Status
    Not applicable
    Location
    Site Ref # / Investigator 52271
    Barcelona, Spain, 08035
    Status
    Not applicable
    Location
    Site Ref # / Investigator 52270
    Barcelona, Spain, 8036
    Status
    Not applicable
    Location
    Site Ref # / Investigator 52362
    Cartagena, Spain, 30203
    Status
    Not applicable
    Location
    Site Ref # / Investigator 53650
    Castellon, Spain, 12004
    Status
    Not applicable
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