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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT01375881 |
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Date of registration:
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09/06/2011 |
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Primary sponsor: |
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Public title:
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Non-interventional Study on Use of Darunavir With Ritonavir in Clinical Practice
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Scientific title:
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Post Authorization Non-interventional Study in HIV1-Infected Patients Starting or Already in Treatment With Darunavir |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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900 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01375881 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort
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Contacts
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Name:
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Janssen-Cilag S.p.A. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen-Cilag S.p.A. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Drug: darunavir/ritonavir plus background regimen
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Primary Outcome(s)
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Measurement of viral load, as an assessment of efficacy
[Time Frame: At least 48 weeks]
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Secondary Outcome(s)
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Assessments of non-categorized information gathered about treatment switch to and from darunavir
[Time Frame: At least 48 weeks]
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Immunological response, as measured by CD4 cells count
[Time Frame: At least 48 weeks]
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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]
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Neuropsychological impairment at baseline and after switching to a darunavir containing regimen in accordance to the approved indication
[Time Frame: At least 48 weeks]
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Number of patients with adverse events, as a measure of safety
[Time Frame: At least 48 weeks]
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Secondary ID(s)
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CR017641
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TMC114HIV4042
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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