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

Completed

• Conditions: HIV Infections

• Registration Number: NCT00615290
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-01-31
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-14
• Primary Completion: 2009-05
• Results First Submitted: 2010-02-03
• Results First Submitted QC: 2010-02-03
• Results First Posted: 2010-02-23
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-06
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of Early Virological Response	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
Viral Load Response at 1 Month	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.
CD4 Count at 1 Month	1 month after inclusion
Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL	3 months after inclusion	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	3 months after inclusion	Number of patients with a viral load \< 50 copies/mL after 3 months of treatment
Viral Load Response at 3 Months	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.
CD4 Count at 3 Months	3 months after inclusion
Patient Self Perception of the New Treatment	Day 0, month 3 and month 6	Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied"

Trial Locations

Locations (2)

1182.127.3301 Boehringer Ingelheim Investigational Site; 🇫🇷 Strasbourg, France

Boehringer Ingelheim Investigational Site; 🇫🇷 Villeneuve St G, France