Non-interventional Study on Use of Darunavir With Ritonavir in Clinical Practice
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ClinicalTrials.gov Identifier: NCT01375881 |
Recruitment Status
:
Completed
First Posted
: June 17, 2011
Last Update Posted
: May 6, 2013
|
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Condition or disease | Intervention/treatment |
---|---|
HIV Infections | Drug: darunavir/ritonavir plus background regimen |
Study Type : | Observational |
Actual Enrollment : | 31 participants |
Observational Model: | Cohort |
Official Title: | Post Authorization Non-interventional Study in HIV1-Infected Patients Starting or Already in Treatment With Darunavir |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- Measurement of viral load, as an assessment of efficacy [ Time Frame: At least 48 weeks ]
- Immunological response, as measured by CD4 cells count [ Time Frame: At least 48 weeks ]
- 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 ]
- Neuropsychological impairment at baseline and after switching to a darunavir containing regimen in accordance to the approved indication [ Time Frame: At least 48 weeks ]
- Assessments of non-categorized information gathered about treatment switch to and from darunavir [ Time Frame: At least 48 weeks ]
- Number of patients with adverse events, as a measure of safety [ Time Frame: At least 48 weeks ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375881
Study Director: | Janssen-Cilag S.p.A. Clinical Trial | Janssen-Cilag S.p.A. |
Responsible Party: | Janssen-Cilag S.p.A. |
ClinicalTrials.gov Identifier: | NCT01375881 History of Changes |
Other Study ID Numbers: |
CR017641 TMC114HIV4042 ( Other Identifier: Janssen-Cilag S.p.A., Italy ) |
First Posted: | June 17, 2011 Key Record Dates |
Last Update Posted: | May 6, 2013 |
Last Verified: | May 2013 |
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 |