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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615290
First received: January 31, 2008
Last updated: February 24, 2014
Last verified: February 2014

January 31, 2008
February 24, 2014
June 2007
May 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
To estimate percentage of responder patients (viral load < 50 copies/mL) after 6 months of treatment by Aptivus in a daily clinical pratice and to evaluate the clinical benefit of Aptivus use. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00615290 on ClinicalTrials.gov Archive Site
  • Evaluation of Early Virological Response [ Time Frame: 1 month after inclusion ] [ Designated as safety issue: No ]
    Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10
  • Viral Load Response at 1 Month [ Time Frame: 1 month after inclusion ] [ Designated as safety issue: No ]
  • CD4 Count at 1 Month [ Time Frame: 1 month after inclusion ] [ Designated as safety issue: No ]
  • Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
    Number of patients with a viral load < 400 copies/mL after 3 months of treatment
  • Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
    Number of patients with a viral load < 50 copies/mL after 3 months of treatment
  • Viral Load Response at 3 Months [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
  • CD4 Count at 3 Months [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
  • Patient Self Perception of the New Treatment [ Time Frame: Day 0, month 3 and month 6 ] [ Designated as safety issue: No ]
    Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied"
To describe Aptivus patient profile To evaluate early virological and intermediate response (month 1 and 3) To evaluate Aptivus safety in daily clinical practice To evaluate patient selfperception on treatment change and his/her health [ Time Frame: 6 months ]
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Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy
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

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

HIV-infected patients

HIV Infections
Drug: tipranavir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
May 2009   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00615290
1182.127
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP