- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00614302
Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Population
October 1, 2009 updated by: Boehringer Ingelheim
Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Patient Population
Data collection for better patient characterization in a highly treatment experienced population. Studying the clinical practice for the treatment of HIV multiexperienced patients in the real life.
The research will be divided into two phases:
- The first phase intends to define and understand the clinical practice using a questionnaire about general topics: definitions of multiexperienced patients and VL failure, therapeutic strategies and behaviour in particular cases.
- The second part of the research will collect the clinical data of double PIs failure patients.
Study Overview
Study Type
Observational
Enrollment (Actual)
428
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ancona, Italy
- Boehringer Ingelheim Investigational Site
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Bari, Italy
- Boehringer Ingelheim Investigational Site
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Benevento, Italy
- Boehringer Ingelheim Investigational Site
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Bisceglie, Italy
- Boehringer Ingelheim Investigational Site
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Bologna, Italy
- Boehringer Ingelheim Investigational Site
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Brescia, Italy
- Boehringer Ingelheim Investigational Site
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Busto, Italy
- Boehringer Ingelheim Investigational Site
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Caserta, Italy
- Boehringer Ingelheim Investigational Site
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Catania, Italy
- Boehringer Ingelheim Investigational Site
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Cremona, Italy
- Boehringer Ingelheim Investigational Site
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Firenze, Italy
- Boehringer Ingelheim Investigational Site
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Genova, Italy
- Boehringer Ingelheim Investigational Site
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Legnano, Italy
- Boehringer Ingelheim Investigational Site
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Milano, Italy
- Boehringer Ingelheim Investigational Site
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Napoli, Italy
- Boehringer Ingelheim Investigational Site
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Padova, Italy
- Boehringer Ingelheim Investigational Site
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Palermo, Italy
- Boehringer Ingelheim Investigational Site
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Pavia, Italy
- Boehringer Ingelheim Investigational Site
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Roma, Italy
- Boehringer Ingelheim Investigational Site
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Sassari, Italy
- Boehringer Ingelheim Investigational Site
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Torino, Italy
- Boehringer Ingelheim Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
HIV patients
Description
Inclusion Criteria:
Patients double PIs failure
Exclusion Criteria:
Not Applicable
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To study in the clinical practice the choice of a specific salvage regimen for multiexperienced patients.
Time Frame: 48 weeks
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reason of each VL failure or switching
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
January 31, 2008
First Submitted That Met QC Criteria
February 12, 2008
First Posted (Estimate)
February 13, 2008
Study Record Updates
Last Update Posted (Estimate)
October 2, 2009
Last Update Submitted That Met QC Criteria
October 1, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1182.130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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