Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615290
First received: January 31, 2008
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

To obtain information on clinical practices for patients treated by Aptivus in real life


Condition Intervention
HIV Infections
Drug: tipranavir

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3 [ Time Frame: 6 months after inclusion ] [ Designated as safety issue: No ]
    The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3


Secondary Outcome Measures:
  • Evaluation of Early Virological Response [ Time Frame: 1 month after inclusion ] [ Designated as safety issue: No ]
    Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10

  • Viral Load Response at 1 Month [ Time Frame: 1 month after inclusion ] [ Designated as safety issue: No ]
  • CD4 Count at 1 Month [ Time Frame: 1 month after inclusion ] [ Designated as safety issue: No ]
  • Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
    Number of patients with a viral load < 400 copies/mL after 3 months of treatment

  • Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
    Number of patients with a viral load < 50 copies/mL after 3 months of treatment

  • Viral Load Response at 3 Months [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
  • CD4 Count at 3 Months [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
  • Patient Self Perception of the New Treatment [ Time Frame: Day 0, month 3 and month 6 ] [ Designated as safety issue: No ]
    Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied"


Enrollment: 42
Study Start Date: June 2007
Primary Completion Date: May 2009 (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:   Probability Sample
Study Population

HIV-infected patients

Criteria

Inclusion Criteria:

  • HIV positive patients for whom Aptivus treatment is initiated by their physician
  • Aptivus SCP respect

Exclusion Criteria:

None if the inclusion criteria are respected: observational study

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615290

Locations
France
Boehringer Ingelheim Investigational Site
Agen, France
Boehringer Ingelheim Investigational Site
Aix En Provence, France
Boehringer Ingelheim Investigational Site
Amiens, France
Boehringer Ingelheim Investigational Site
Argenteuil, France
Boehringer Ingelheim Investigational Site
Aulnay Sous Bois, France
Boehringer Ingelheim Investigational Site
Auxerre, France
Boehringer Ingelheim Investigational Site
Belfort, France
Boehringer Ingelheim Investigational Site
Besancon Cedex, France
Boehringer Ingelheim Investigational Site
Beziers, France
Boehringer Ingelheim Investigational Site
Bondy, France
Boehringer Ingelheim Investigational Site
Bordeaux, France
Boehringer Ingelheim Investigational Site
Briis Sous Forges, France
Boehringer Ingelheim Investigational Site
Cahors, France
Boehringer Ingelheim Investigational Site
Cannes, France
Boehringer Ingelheim Investigational Site
Chartres, France
Boehringer Ingelheim Investigational Site
Corbeil Essonnes, France
Boehringer Ingelheim Investigational Site
Creil, France
Boehringer Ingelheim Investigational Site
Creteil, France
Boehringer Ingelheim Investigational Site
DAX, France
Boehringer Ingelheim Investigational Site
Digne, France
Boehringer Ingelheim Investigational Site
Garches, France
Boehringer Ingelheim Investigational Site
La Roche Sur Yon, France
Boehringer Ingelheim Investigational Site
Le Mans, France
Boehringer Ingelheim Investigational Site
Le Petit Quevilly, France
Boehringer Ingelheim Investigational Site
Libourne, France
Boehringer Ingelheim Investigational Site
Lyon, France
Boehringer Ingelheim Investigational Site
Mantes La Jolie, France
Boehringer Ingelheim Investigational Site
Marseille, France
Boehringer Ingelheim Investigational Site
Metz, France
Boehringer Ingelheim Investigational Site
Mulhouse, France
Boehringer Ingelheim Investigational Site
Nancy, France
Boehringer Ingelheim Investigational Site
Nantes, France
Boehringer Ingelheim Investigational Site
Nevers, France
Boehringer Ingelheim Investigational Site
Nice, France
Boehringer Ingelheim Investigational Site
Orleans, France
Boehringer Ingelheim Investigational Site
Paris, France
Boehringer Ingelheim Investigational Site
Perigueux, France
Boehringer Ingelheim Investigational Site
Poitiers, France
Boehringer Ingelheim Investigational Site
Rouen, France
Boehringer Ingelheim Investigational Site
Saint Brieuc, France
Boehringer Ingelheim Investigational Site
Saint Nazaire, France
Boehringer Ingelheim Investigational Site
Saint-mande, France
1182.127.3301 Boehringer Ingelheim Investigational Site
Strasbourg, France
Boehringer Ingelheim Investigational Site
Strasbourg, France
Boehringer Ingelheim Investigational Site
Suresnes, France
Boehringer Ingelheim Investigational Site
Toulouse, France
Boehringer Ingelheim Investigational Site
Valenciennes, France
Boehringer Ingelheim Investigational Site
Villeneuve St G, France
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00615290     History of Changes
Other Study ID Numbers: 1182.127
Study First Received: January 31, 2008
Results First Received: February 3, 2010
Last Updated: February 24, 2014
Health Authority: France: Comite consultatif sur le traitement de l'information en matiere de recherche dans le domaine de la sante (CCTIRS)

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
Tipranavir
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014