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

Purpose

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 The patient must be withdrawn from the study if the treatment with darunavir has been stopped.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

Condition	Intervention	Phase
HIV Infections	Drug: darunavir/ritonavir plus background regimen	Phase 4


Study Type:	Observational
Study Design:	Observational Model: Cohort
Official Title:	Post Authorization Non-interventional Study in HIV1-Infected Patients Starting or Already in Treatment With Darunavir

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Darunavir Darunavir ethanolate

U.S. FDA Resources

Further study details as provided by Janssen-Cilag S.p.A.:

Primary Outcome Measures:

Measurement of viral load, as an assessment of efficacy [ Time Frame: At least 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunological response, as measured by CD4 cells count [ Time Frame: At least 48 weeks ] [ Designated as safety issue: No ]
Impact on Health-related Quality of Life after switching to a darunavir containing regimen in accordance to the approved indication [ Time Frame: At least 48 weeks ] [ Designated as safety issue: No ]
Neuropsychological impairment at baseline and after switching to a darunavir containing regimen in accordance to the approved indication [ Time Frame: At least 48 weeks ] [ Designated as safety issue: No ]
Assessments of non-categorized information gathered about treatment switch to and from darunavir [ Time Frame: At least 48 weeks ] [ Designated as safety issue: No ]
Number of patients with adverse events, as a measure of safety [ Time Frame: At least 48 weeks ] [ Designated as safety issue: No ]


Enrollment:	31
Study Start Date:	June 2009
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
001 darunavir/ritonavir plus background regimen darunavir/ritonavir oral use in naive and experienced patients at approved dosages	Drug: darunavir/ritonavir plus background regimen darunavir/ritonavir, oral use, in naive and experienced patients at approved dosages

Detailed Description:

The patient's baseline data will be collected within the first week before darunavir administration, Visit 1. For patients already in treatment with darunavir, outside the Early Access Program, baseline and follow-up data will be collected retrospectively and prospectively. For patients switched to commercial darunavir from the Early Access Program and already in treatment with darunavir, Baseline Visit data will be collected from the Early Access Program Baseline Visit. For patients already in treatment with darunavir outside the Early Access Program, baseline data will be collected retrospectively starting from the first darunavir intake. For all patients, laboratory examination results collected within 6 months before darunavir treatment starts will be considered as baseline data. For patients switched to commercial darunavir from the Early Access Program and already in treatment with darunavir, Visit 2 won't be performed. For patients starting commercial darunavir or already in treatment with commercial darunavir outside the Early Access Program, laboratory exams related to follow-up visits, Visit 2 onward, can be performed within a time window of one month before or after the corresponding visit date. 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. If a patient stops treatment with darunavir at any time, the end of study visit should be performed as soon as possible. Darunavir film-coated tablet, orally administered. Orange, oval-shaped tablet, debossed with 400MG or 600MG or 300MG on one side and TMC on the other side. Duration of observation minimum 48 weeks.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient using darunavir and ritonavir in clinical practice according to label in Italy. Both naive and experienced patients are allowed to enter the study

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375881

Sponsors and Collaborators

Janssen-Cilag S.p.A.

Investigators


Study Director:	Janssen-Cilag S.p.A. Clinical Trial	Janssen-Cilag S.p.A.

More Information


Responsible Party:	Janssen-Cilag S.p.A.
ClinicalTrials.gov Identifier:	NCT01375881 History of Changes
Other Study ID Numbers:	CR017641 TMC114HIV4042
Study First Received:	June 9, 2011
Last Updated:	May 3, 2013
Health Authority:	Italy: National Institute of Health

Keywords provided by Janssen-Cilag S.p.A.:


HIV darunavir ritonavir	Prezista naive experienced

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Darunavir	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016