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Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Population

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ClinicalTrials.gov Identifier: NCT00614302
Recruitment Status : Completed
First Posted : February 13, 2008
Last Update Posted : October 2, 2009
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.

Condition or disease Intervention/treatment
HIV Infections Drug: TPV

Study Design
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Study Type : Observational
Actual Enrollment : 428 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Patient Population
Study Start Date : June 2007
Actual Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To study in the clinical practice the choice of a specific salvage regimen for multiexperienced patients. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Reason of each VL failure or switching [ Time Frame: 48 weeks ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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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
Study Population
HIV patients
Criteria

Inclusion Criteria:

Patients double PIs failure

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT00614302


Locations
Italy
Boehringer Ingelheim Investigational Site
Ancona, Italy
Boehringer Ingelheim Investigational Site
Bari, Italy
Boehringer Ingelheim Investigational Site
Benevento, Italy
Boehringer Ingelheim Investigational Site
Bisceglie, Italy
Boehringer Ingelheim Investigational Site
Bologna, Italy
Boehringer Ingelheim Investigational Site
Brescia, Italy
Boehringer Ingelheim Investigational Site
Busto, Italy
Boehringer Ingelheim Investigational Site
Caserta, Italy
Boehringer Ingelheim Investigational Site
Catania, Italy
Boehringer Ingelheim Investigational Site
Cremona, Italy
Boehringer Ingelheim Investigational Site
Firenze, Italy
Boehringer Ingelheim Investigational Site
Genova, Italy
Boehringer Ingelheim Investigational Site
Legnano, Italy
Boehringer Ingelheim Investigational Site
Milano, Italy
Boehringer Ingelheim Investigational Site
Napoli, Italy
Boehringer Ingelheim Investigational Site
Padova, Italy
Boehringer Ingelheim Investigational Site
Palermo, Italy
Boehringer Ingelheim Investigational Site
Pavia, Italy
Boehringer Ingelheim Investigational Site
Roma, Italy
Boehringer Ingelheim Investigational Site
Sassari, Italy
Boehringer Ingelheim Investigational Site
Torino, Italy
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00614302     History of Changes
Other Study ID Numbers: 1182.130
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009

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