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NCT00615290 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00615290
Other study ID # 1182.127
Secondary ID
Status Completed
Phase N/A
First received January 31, 2008
Last updated August 6, 2014
Start date June 2007

Study information
Verified date August 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority France: Comite consultatif sur le traitement de l'information en matiere de recherche dans le domaine de la sante (CCTIRS)
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• tipranavir

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Evaluation of Early Virological Response Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10 1 month after inclusion No
Secondary Viral Load Response at 1 Month Please note that a reported value of "49 copies/mL" for the median or first quartile indicates that the observed statistic for the outcome measure is below the "limit of quantification" for viral load. The limit of quantification is 50 copies/mL. 1 month after inclusion No
Secondary CD4 Count at 1 Month 1 month after inclusion No
Secondary Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL Number of patients with a viral load < 400 copies/mL after 3 months of treatment 3 months after inclusion No
Secondary Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL Number of patients with a viral load < 50 copies/mL after 3 months of treatment 3 months after inclusion No
Secondary Viral Load Response at 3 Months Please note that a reported value of "49 copies/mL" for the median or first quartile indicates that the observed statistic for the outcome measure is below the "limit of quantification" for viral load. The limit of quantification is 50 copies/mL. 3 months after inclusion No
Secondary CD4 Count at 3 Months 3 months after inclusion No
Secondary Patient Self Perception of the New Treatment Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied" Day 0, month 3 and month 6 No
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