treatment perception of qd (once a day) dosed kaletra (tablets)

Conditions: Human Immunodeficiency Virus Infection

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.

this is a multicenter, post-marketing, observational, cross-sectional (single visit) study in hiv-infected patients treated with a combination of antiretroviral treatment (art) containing lpv/r 200/50 mg tablets dosed qd for at least 12 weeks to assess the participants' satisfaction and adherence level with lpv/r qd art as measured by specific validated participant questionnaires. as this is a non-interventional study, the decision to enroll a participant was separate from the decision to treat the subject with lpv/r. prescription of lpv/r and duration of treatment were the responsibility of the treating physician. in addition, the overall study population was compared to cohort 2 (394 patients on lpv/r bid for ≥3 months to \<2 years) from kapital2, a post-marketing observational, cross-sectional, single visit, multicenter, national study. for further details on this study, please see: casado jl, griffa l, cabrero e, burgos a, norton m and the kapital 2 collaborative group. a study of treatment satisfaction reported by patients on lopinavir/r anchored regimens and physicians who provide hiv care (kapital 2). 9th international congress on drug therapy in hiv infection. 9th international congress on drug therapy in hiv infection. glasgow, 2008.#p080.

Eligibility 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.

Keywords: treatment satisfaction adherence to treatment