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

August 6, 2014 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • Boehringer Ingelheim Investigational Site
      • Strasbourg, France
        • 1182.127.3301 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
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HIV-infected patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month after inclusion
Viral Load Response at 1 Month
Time Frame: 1 month after inclusion
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
CD4 Count at 1 Month
Time Frame: 1 month after inclusion
1 month after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL
Time Frame: 3 months after inclusion
Number of patients with a viral load < 400 copies/mL after 3 months of treatment
3 months after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL
Time Frame: 3 months after inclusion
Number of patients with a viral load < 50 copies/mL after 3 months of treatment
3 months after inclusion
Viral Load Response at 3 Months
Time Frame: 3 months after inclusion
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
CD4 Count at 3 Months
Time Frame: 3 months after inclusion
3 months after inclusion
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"
Day 0, month 3 and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 13, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 6, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1182.127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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