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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	HIV Infections
Intervention:	Drug: Tipranavir

Participant Flow

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	Full Analysis Set for trial 1182.17 (FAS17). Patients from trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444), and TPV/r arm from 1182.12(NCT00054717) and 1182.48(NCT00144170)
Group 2 (Highly Treatment Experienced Patients)	FAS17. Patients from trial 1182.51.
Group 3 (Tipranavir naïve Patients)	FAS17. CPI/r patients from trials 1182.12 and 1182.48 (CPI/r failures) and one 1182.4 patient who failed his SQV

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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Reporting Groups

	Description
Group 1 (Patients With Varying Degrees of Treatment Experience	Full Analysis Set for trial 1182.17 (FAS17). Patients from trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444), and TPV/r arm from 1182.12(NCT00054717) and 1182.48(NCT00144170)
Group 2 (Highly Treatment Experienced Patients)	FAS17. Patients from trial 1182.51.
Group 3 (Tipranavir naïve Patients)	FAS17. CPI/r patients from trials 1182.12 and 1182.48 (CPI/r failures) and one 1182.4 patient who failed his SQV
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 Aquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 - Haemoglobin [ Time Frame: End of Trial (>288 weeks) ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Primary:

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

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8. Primary:

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

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9. Primary:

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

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10. Primary:

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

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11. Primary:

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

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12. Primary:

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

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13. Primary:

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

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14. Primary:

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

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15. Primary:

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

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16. Primary:

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

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17. Primary:

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

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18. Primary:

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

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19. Primary:

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

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20. Primary:

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

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21. Primary:

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

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22. Primary:

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

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23. Primary:

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

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24. Primary:

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

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25. Secondary:

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

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26. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

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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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, Study Chair, 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:	May 18, 2012
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 United States: Food and Drug Administration