Non-interventional Study on Use of Darunavir With Ritonavir in Clinical Practice

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 The patient must be withdrawn from the study if the treatment with darunavir has been stopped.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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag S.p.A.
• Treatments: Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• Eligible for inclusion in this non-interventional study are adult patients in need of treatment with darunavir according to Italian label or already in treatment

• Having provided a signed and dated Informed Consent Form

Exclusion Criteria:

• A known hypersensitivity to darunavir or to any of its excipients

• Severe hepatic impairment described as Child-Pugh class C

• Pregnancy or lactation

• Patient previously treated with darunavir that was discontinued for any reason