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To obtain information on clinical practices for patients treated by Aptivus in real life
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tipranavir | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Viral Load Response at 1 Month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
None if the inclusion criteria are respected: observational study
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HIV-infected patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Agen | France | ||||
| Boehringer Ingelheim Investigational Site |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Aptivus | Patients treated by Aptivus in daily practice |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | 1 month after inclusion |
| 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 |
| 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 |
| 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 |
| CD4 Count at 3 Months | 3 months after inclusion |
| 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 |
| 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 | Besançon | France |
| Boehringer Ingelheim Investigational Site | Béziers | 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 | Créteil | France |
| Boehringer Ingelheim Investigational Site | Dax | France |
| Boehringer Ingelheim Investigational Site | Digne-les-Bains | 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 | Orléans | France |
| Boehringer Ingelheim Investigational Site | Paris | France |
| Boehringer Ingelheim Investigational Site | Périgueux | 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-Mandé | France |
| Boehringer Ingelheim Investigational Site | Saint-Nazaire | 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 Saint G | France |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Aptivus | Patients treated by Aptivus in daily practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All enrolled patients with data at 6 months | Posted | Number | participants | 6 months after inclusion |
|
|
| ||||||||||||||||||||||||||
| 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 | All enrolled patients with data at 1 month | Posted | Number | participants | 1 month after inclusion |
|
| |||||||||||||||||||||||||||
| 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. | All enrolled patients with data at 1 month | Posted | Median | Inter-Quartile Range | copies/mL | 1 month after inclusion |
|
| ||||||||||||||||||||||||||
| Secondary | CD4 Count at 1 Month | All enrolled patients with data at 1 month | Posted | Median | Inter-Quartile Range | cells/cubic millimeter | 1 month after inclusion |
|
|
| ||||||||||||||||||||||||||
| 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 | All enrolled patients with data at 3 months | Posted | Number | participants | 3 months after inclusion |
|
| |||||||||||||||||||||||||||
| 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 | All enrolled patients with data at 3 months | Posted | Number | participants | 3 months after inclusion |
|
| |||||||||||||||||||||||||||
| 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. | All enrolled patients with data at 3 months | Posted | Median | Inter-Quartile Range | copies/mL | 3 months after inclusion |
|
| ||||||||||||||||||||||||||
| Secondary | CD4 Count at 3 Months | All enrolled patients with data at 3 months | Posted | Median | Inter-Quartile Range | cells/cubic millimeter | 3 months after inclusion |
|
|
| ||||||||||||||||||||||||||
| Secondary | Patient Self Perception of the New Treatment | Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied" | All enrolled patients | Posted | Mean | Standard Deviation | millimeter | Day 0, month 3 and month 6 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aptivus | Patients treated by Aptivus in daily practice | 3 | 42 | 0 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytolitic hepatitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C107201 | tipranavir |
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title |
|---|
| Denominators |
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| Categories |
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| Title |
|---|
| Denominators |
|---|
| Categories |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Day 0 (n=28) |
| |||||
| Month 3 (n=28) |
| |||||
| Month 6 (n=23) |
|