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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00614302
First received: January 31, 2008
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention
HIV Infections
 Drug: TPV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Italian Prospective Data Collection for Better Patient Characterization in a Highly Treatment Experienced Patient Population

Resource links provided by NLM:

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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

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

Enrollment: 428
Study Start Date: June 2007
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HIV patients

Criteria

Inclusion Criteria:

Patients double PIs failure

Exclusion Criteria:

Not Applicable

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00614302     History of Changes
Other Study ID Numbers: 1182.130
Study First Received: January 31, 2008
Last Updated: October 1, 2009
Health Authority: Italy: NA

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013