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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00614302

First Posted: February 13, 2008

Last Update Posted: October 2, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Boehringer Ingelheim

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:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00614302 History of Changes
Other Study ID Numbers:	1182.130
First Submitted:	January 31, 2008
First Posted:	February 13, 2008
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

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