Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy
1 other identifier
observational
42
1 country
48
Brief Summary
To obtain information on clinical practices for patients treated by Aptivus in real life
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 31, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedResults Posted
Study results publicly available
February 23, 2010
CompletedAugust 8, 2014
August 1, 2014
1.9 years
January 31, 2008
February 3, 2010
August 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3
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
6 months after inclusion
Secondary Outcomes (8)
Evaluation of Early Virological Response
1 month after inclusion
Viral Load Response at 1 Month
1 month after inclusion
CD4 Count at 1 Month
1 month after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL
3 months after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL
3 months after inclusion
- +3 more secondary outcomes
Interventions
Eligibility Criteria
HIV-infected patients
You may qualify if:
- HIV positive patients for whom Aptivus treatment is initiated by their physician
- Aptivus SCP respect
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
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
Besançon, France
Boehringer Ingelheim Investigational Site
Béziers, 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
Créteil, France
Boehringer Ingelheim Investigational Site
Dax, France
Boehringer Ingelheim Investigational Site
Digne-les-Bains, 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
Orléans, France
Boehringer Ingelheim Investigational Site
Paris, France
Boehringer Ingelheim Investigational Site
Périgueux, 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-Mandé, France
Boehringer Ingelheim Investigational Site
Saint-Nazaire, 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 Saint G, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 31, 2008
First Posted
February 14, 2008
Study Start
June 1, 2007
Primary Completion
May 1, 2009
Last Updated
August 8, 2014
Results First Posted
February 23, 2010
Record last verified: 2014-08