Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00615290
First received: January 31, 2008
Last updated: May 18, 2012
Last verified: May 2012
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Tipranavir
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
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 ]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 ]Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10
- Evaluation of Intermediate Virological Response [ Time Frame: 3 months after inclusion ]Number of patients with a viral load < 400 copies/mL
- Patient Self Perception of the New Treatment [ Time Frame: Day 0, month 3 and month 6 ]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
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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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: | May 18, 2012 |
| 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 May 23, 2013