Non-interventional Study on Use of Darunavir With Ritonavir in Clinical Practice
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this non-interventional study is a description of use of darunavir in daily
practice, in retrospective and perspective manner. Darunavir will be prescribed in the usual
manner and in accordance with the terms of marketing authorization. The assignment of a
patient to a particular therapeutic strategy will not be decided in advance by this study
protocol but instead, it will be part of the current clinical practice. The prescription of
the medicinal product will be clearly separated from the decision to include the patient in
the study. No additional diagnostic or monitoring procedures will be applied to the patients,
and epidemiological methods will be used for the analysis of collected data. After having
agreed with the patient on starting treatment with darunavir, and provided that all inclusion
and exclusion criteria apply, the physician will document the patient's data. Patients will
be observed for at least 48 weeks from baseline visit except for those who withdraw from the
study earlier. Patients data will be collected at approximately 0, 1, 3 and 6 months after
starting treatment and subsequently every 3 months in accordance with routine practice. The
expected number of patients to enroll is about 900. The patients will be treated with
darunavir according to the Italian label. The patient must be withdrawn from the study if the
treatment with darunavir has been stopped. A last evaluation must be documented when
possible, and a resistance test will be collected if available for patients discontinuing for
virologic failure. At the end of study visit, information on therapy given after darunavir
discontinuation will be collected. For patients discontinuing for virologic failure, data
will be collected until the end of the present study, and at least two consecutive
measurements of viral load after starting new antiretroviral therapy will be collected, if
available. All data collected must be the result of the normal medical care of the patient.
The patient's baseline data will be collected within the first week before darunavir
administration (at Visit 1). For patients already in treatment with darunavir, baseline and
follow up data will be collected retrospectively and prospectively. Further data collection
will occur approximately at 1, 3, and 6 months and subsequently about every 3 months
according to routine practice, after initiating darunavir treatment.