Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00146328
First received: September 5, 2005
Last updated: January 31, 2014
Last verified: January 2014
Results First Received: May 26, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Tipranavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group 1 (Patients With Varying Degrees of Treatment Experience Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
Group 2 (Highly Treatment Experienced Patients) Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
Group 3 (Tipranavir naïve Patients) Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.

Participant Flow:   Overall Study
    Group 1 (Patients With Varying Degrees of Treatment Experience     Group 2 (Highly Treatment Experienced Patients)     Group 3 (Tipranavir naïve Patients)  
STARTED     291     255     449  
COMPLETED     150     101     158  
NOT COMPLETED     141     154     291  
Adverse Event                 39                 48                 79  
Protocol Violation                 11                 6                 12  
Lost to Follow-up                 7                 4                 7  
Withdrawal by Subject                 16                 16                 22  
Virologic Failure/lack of efficacy                 54                 72                 142  
Trial ended/site closed                 8                 2                 19  
Patient decision to end                 0                 1                 6  
Enroll into other trial                 2                 4                 2  
Death                 0                 1                 1  
Moved                 2                 0                 0  
Interaction with other medication                 2                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 (Patients With Varying Degrees of Treatment Experience A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 291 patients were categorized into Group 1. Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48.
Group 2 (Highly Treatment Experienced Patients) A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 255 patients were categorized into Group 2. Group 2: Patients from 1182.51 who rolled over into 1182.17.
Group 3 (Tipranavir naïve Patients) A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 449 patients were categorized into Group 3. Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.
Total Total of all reporting groups

Baseline Measures
    Group 1 (Patients With Varying Degrees of Treatment Experience     Group 2 (Highly Treatment Experienced Patients)     Group 3 (Tipranavir naïve Patients)     Total  
Number of Participants  
[units: participants]
  291     255     449     995  
Age  
[units: years]
Mean ± Standard Deviation
  43.7  ± 8     45.6  ± 8.2     43.5  ± 7.7     44.1  ± 8  
Gender  
[units: participants]
       
Female     35     20     44     99  
Male     256     235     405     896  



  Outcome Measures
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1.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin   [ Time Frame: End of Trial (>288 weeks) ]

2.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - White Blood Cell ct.   [ Time Frame: End of Trial (>288 weeks) ]

3.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Platelets   [ Time Frame: End of Trial (>288 weeks) ]

4.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Prothrombin Time   [ Time Frame: End of Trial (>288 weeks) ]

5.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Sodium   [ Time Frame: End of Trial (>288 weeks) ]

6.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Potassium   [ Time Frame: End of Trial (>288 weeks) ]

7.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Calcium   [ Time Frame: End of Trial (>288 weeks) ]

8.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Phosphate   [ Time Frame: End of Trial (>288 weeks) ]

9.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Carbon Dioxide   [ Time Frame: End of Trial (>288 weeks) ]

10.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Aspartate Aminotransferase (AST/GOT,SGOT)   [ Time Frame: End of Trial (>288 weeks) ]

11.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alanine Aminotransferase (ALT/GPT,SGPT)   [ Time Frame: End of Trial (>288 weeks) ]

12.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Alkaline Phosphatase   [ Time Frame: End of Trial (>288 weeks) ]

13.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Amylase   [ Time Frame: End of Trial (>288 weeks) ]

14.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatine Phosphokinase   [ Time Frame: End of Trial (>288 weeks) ]

15.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Lipase   [ Time Frame: End of Trial (>288 weeks) ]

16.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Glucose   [ Time Frame: End of Trial (>288 weeks) ]

17.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Cholesterol, Total   [ Time Frame: End of Trial (>288 weeks) ]

18.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Creatinine   [ Time Frame: End of Trial (>288 weeks) ]

19.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Bilirubin, Total   [ Time Frame: End of Trial (>288 weeks) ]

20.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Triglycerides   [ Time Frame: End of Trial (>288 weeks) ]

21.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Uric Acid   [ Time Frame: End of Trial (>288 weeks) ]

22.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Albumin   [ Time Frame: End of Trial (>288 weeks) ]

23.  Primary:   Number of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 -Low-density Lipoprotein (LDL)   [ Time Frame: End of Trial (>288 weeks) ]

24.  Primary:   Number of Patients With Adverse Events Leading to Death   [ Time Frame: End of Trial (>288 weeks) ]

25.  Secondary:   Change From Baseline in Human Immunodeficiency Virus-Ribonucleic Acid (HIV-RNA) Viral Load - Last Observation Carried Forward (LOCF)   [ Time Frame: Baseline to 192-240 week time interval ]

26.  Secondary:   Change From Baseline in CD4 Cell Count (LOCF)   [ Time Frame: Baseline to 192-240 week time interval ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Pharmaceuticals
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00146328     History of Changes
Other Study ID Numbers: 1182.17
Study First Received: September 5, 2005
Results First Received: May 26, 2009
Last Updated: January 31, 2014
Health Authority: Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología)
Australia: Responsilble Ethics Committee
Belgium: Federal Agency for Medicines and Health Products, FAMHP
United States: Food and Drug Administration