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The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with HIV-1 infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tipranavir | Drug |
| ||
| ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Adverse Events (AE) | Any type of adverse events | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic Response | Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients. |
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Inclusion criteria:
Exclusion criteria:
The exclusion criteria follow the same criteria which are describe in the newest SPC
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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 9 | Arad | Romania | ||||
| Boehringer Ingelheim Investigational site 13 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aptivus and Ritonavir | TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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low-dose |
|
| 48 weeks |
| Change in CD4+ Cell Count From Baseline at Week 48 | 48 weeks |
| Bacau |
| Romania |
| Boehringer Ingelheim Investigational site 17 | Brasov | Romania |
| Boehringer Ingelheim Investigational site 18 | Brasov | Romania |
| Boehringer Ingelheim Investigational site 19 | Brasov | Romania |
| Boehringer Ingelheim Investigational site 1 | Bucharest | Romania |
| Boehringer Ingelheim Investigational site 2 | Bucharest | Romania |
| Boehringer Ingelheim Investigational site 3 | Bucharest | Romania |
| Boehringer Ingelheim Investigational site 4 | Bucharest | Romania |
| Boehringer Ingelheim Investigational site 5 | Bucharest | Romania |
| Boehringer Ingelheim Investigational site 6 | Bucharest | Romania |
| Boehringer Ingelheim Investigational site 7 | Bucharest | Romania |
| Boehringer Ingelheim Investigational site 8 | Bucharest | Romania |
| Boehringer Ingelheim Investigational site 16 | Constanța | Romania |
| Boehringer Ingelheim Investigational site 11 | Craiova | Romania |
| Boehringer Ingelheim Investigational site 12 | Craiova | Romania |
| Boehringer Ingelheim Investigational site 15 | Galati | Romania |
| Boehringer Ingelheim Investigational site 20 | Tg.Mures | Romania |
| Boehringer Ingelheim Investigational site 10 | Timișoara | Romania |
| Boehringer Ingelheim Investigational site 14 | Vaslui | Romania |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aptivus and Ritonavir | TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is available for 41 patients. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Baseline HIV RNA values | Number | Participants |
| |||||||||||||||||||||||
| Baseline CD4+ count | Number | 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 Reporting Adverse Events (AE) | Any type of adverse events | Treated set (TS), defined as patients treated with Aptivus | Posted | Number | Participants | 48 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Virologic Response | Virologic response is defined as HIV viral load of < 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL >= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients. | Treated set (TS), defined as patients treated with Aptivus | Posted | Number | Number of participants | 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4+ Cell Count From Baseline at Week 48 | Treated set with with non-missing data at the visit | Posted | Mean | Standard Deviation | cells/mm^3 | 48 weeks |
|
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|
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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 and Ritonavir | ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir | 1 | 42 | 0 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 14.0 | 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 |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 1,000 - <10,000 copies/ml |
|
| 10,000 - <100,000 copies/ml |
|
| 100,000 - <1,000,000 copies/ml |
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| >= 1,000,000 copies/ml |
|
| Missing |
|
| 251 - <451 cells/mm^3 |
|
| >= 451 cells/mm^3 |
|
| Title | Measurements |
|---|---|
|
| Patients with hepatic adverse events |
|
| Patients with dyslipidemia |
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|
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