Clinical trial NCT00615290: Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy
Official title: Pharmaco-epidemiological Description of the Patient Population Treated With Aptivus Under Market Conditions, Safety & Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected patients

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


Eligibility 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

Primary outcomes:
measure: Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Evaluation of Early Virological Response
timeFrame: 1 month after inclusion
measure: Viral Load Response at 1 Month
timeFrame: 1 month after inclusion
measure: CD4 Count at 1 Month
timeFrame: 1 month after inclusion
measure: Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL
timeFrame: 3 months after inclusion
measure: Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL
timeFrame: 3 months after inclusion
measure: Viral Load Response at 3 Months
timeFrame: 3 months after inclusion
measure: CD4 Count at 3 Months
timeFrame: 3 months after inclusion
measure: Patient Self Perception of the New Treatment
timeFrame: Day 0, month 3 and month 6
Other outcomes:
Locations:
city: Agen
country: France
facility: Boehringer Ingelheim Investigational Site
city: Aix En Provence
country: France
facility: Boehringer Ingelheim Investigational Site
city: Amiens
country: France
facility: Boehringer Ingelheim Investigational Site
city: Argenteuil
country: France
facility: Boehringer Ingelheim Investigational Site
city: Aulnay Sous Bois
country: France
facility: Boehringer Ingelheim Investigational Site
city: Auxerre
country: France
facility: Boehringer Ingelheim Investigational Site
city: Belfort
country: France
facility: Boehringer Ingelheim Investigational Site
city: Besancon Cedex
country: France
facility: Boehringer Ingelheim Investigational Site
city: Beziers
country: France
facility: Boehringer Ingelheim Investigational Site
city: Bondy
country: France
facility: Boehringer Ingelheim Investigational Site
city: Bordeaux
country: France
facility: Boehringer Ingelheim Investigational Site
city: Briis Sous Forges
country: France
facility: Boehringer Ingelheim Investigational Site
city: Cahors
country: France
facility: Boehringer Ingelheim Investigational Site
city: Cannes
country: France
facility: Boehringer Ingelheim Investigational Site
city: Chartres
country: France
facility: Boehringer Ingelheim Investigational Site
city: Corbeil Essonnes
country: France
facility: Boehringer Ingelheim Investigational Site
city: Creil
country: France
facility: Boehringer Ingelheim Investigational Site
city: Creteil
country: France
facility: Boehringer Ingelheim Investigational Site
city: DAX
country: France
facility: Boehringer Ingelheim Investigational Site
city: Digne
country: France
facility: Boehringer Ingelheim Investigational Site
city: Garches
country: France
facility: Boehringer Ingelheim Investigational Site
city: La Roche Sur Yon
country: France
facility: Boehringer Ingelheim Investigational Site
city: Le Mans
country: France
facility: Boehringer Ingelheim Investigational Site
city: Le Petit Quevilly
country: France
facility: Boehringer Ingelheim Investigational Site
city: Libourne
country: France
facility: Boehringer Ingelheim Investigational Site
city: Lyon
country: France
facility: Boehringer Ingelheim Investigational Site
city: Mantes La Jolie
country: France
facility: Boehringer Ingelheim Investigational Site
city: Marseille
country: France
facility: Boehringer Ingelheim Investigational Site
city: Metz
country: France
facility: Boehringer Ingelheim Investigational Site
city: Mulhouse
country: France
facility: Boehringer Ingelheim Investigational Site
city: Nancy
country: France
facility: Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: Boehringer Ingelheim Investigational Site
city: Nevers
country: France
facility: Boehringer Ingelheim Investigational Site
city: Nice
country: France
facility: Boehringer Ingelheim Investigational Site
city: Orleans
country: France
facility: Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: Boehringer Ingelheim Investigational Site
city: Perigueux
country: France
facility: Boehringer Ingelheim Investigational Site
city: Poitiers
country: France
facility: Boehringer Ingelheim Investigational Site
city: Rouen
country: France
facility: Boehringer Ingelheim Investigational Site
city: Saint Brieuc
country: France
facility: Boehringer Ingelheim Investigational Site
city: Saint Nazaire
country: France
facility: Boehringer Ingelheim Investigational Site
city: Saint-mande
country: France
facility: Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: 1182.127.3301 Boehringer Ingelheim Investigational Site
city: Strasbourg
country: France
facility: Boehringer Ingelheim Investigational Site
city: Suresnes
country: France
facility: Boehringer Ingelheim Investigational Site
city: Toulouse
country: France
facility: Boehringer Ingelheim Investigational Site
city: Valenciennes
country: France
facility: Boehringer Ingelheim Investigational Site
city: Villeneuve St G
country: France
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: