Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI

This study has been terminated.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00517192

First received: August 15, 2007

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: September 18, 2009

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

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
Tipranavir 500 mg/Ritonavir 200 mg	No text entered.
Darunavir 600 mg/Ritonavir 100 mg	No text entered.

Participant Flow: Overall Study

	Tipranavir 500 mg/Ritonavir 200 mg	Darunavir 600 mg/Ritonavir 100 mg
STARTED	19	20
COMPLETED	0	0
NOT COMPLETED	19	20
Adverse Event	1	1
Lost to Follow-up	1	1
Withdrawal by Subject	1	0
Early termination of the trial	16	18

Baseline Characteristics

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Reporting Groups

	Description
Tipranavir 500 mg/Ritonavir 200 mg	No text entered.
Darunavir 600 mg/Ritonavir 100 mg	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Tipranavir 500 mg/Ritonavir 200 mg	Darunavir 600 mg/Ritonavir 100 mg	Total
Number of Participants [units: participants]	19	20	39
Age [units: Years] Mean ± Standard Deviation	44.3 ± 6.1	43.1 ± 6.2	43.6 ± 6.1
Gender [units: Number of participants]
Female	4	3	7
Male	15	17	32

Outcome Measures

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1. Primary:

Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion. [ Time Frame: 48 weeks of treatment ]

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2. Secondary:

Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure). [ Time Frame: 48 weeks of treatment ]

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3. Secondary:

Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug. [ Time Frame: 48 weeks of treatment ]

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4. Secondary:

Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion. [ Time Frame: 48 weeks of treatment ]

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5. Secondary:

Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored [ Time Frame: up to 48 weeks ]

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6. Secondary:

Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF [ Time Frame: up to 48 weeks ]

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7. Secondary:

Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat [ Time Frame: up to 48 weeks ]

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8. Secondary:

Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored [ Time Frame: up to 48 weeks ]

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9. Secondary:

Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF [ Time Frame: up to 48 weeks ]

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10. Secondary:

Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat [ Time Frame: up to 48 weeks ]

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11. Secondary:

Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored [ Time Frame: up to 48 weeks ]

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Measure Type	Secondary
Measure Title	Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored
Measure Description	No text entered.
Time Frame	up to 48 weeks
Safety Issue

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.
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Reporting Groups

	Description
Tipranavir 500 mg/Ritonavir 200 mg	No text entered.
Darunavir 600 mg/Ritonavir 100 mg	No text entered.

Measured Values

	Tipranavir 500 mg/Ritonavir 200 mg	Darunavir 600 mg/Ritonavir 100 mg
Number of Participants Analyzed [units: participants]	0	0
Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored [units: Percentage of participants]

No statistical analysis provided for Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored

12. Secondary:

Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF [ Time Frame: up to 48 weeks ]

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13. Secondary:

Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat [ Time Frame: up to 48 weeks ]

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14. Secondary:

Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8 [ Time Frame: up to week 8 ]

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15. Secondary:

Daily Average in CD4+ Cell Count Change From Baseline up to Week 24 [ Time Frame: up to week 24 ]

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16. Secondary:

Daily Average in CD4+ Cell Count Change From Baseline up to Week 48 [ Time Frame: up to week 48 ]

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17. Secondary:

Daily Average in Viral Load Change From Baseline up to Week 8 [ Time Frame: up to week 8 ]

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18. Secondary:

Daily Average in Viral Load Change From Baseline up to Week 24 [ Time Frame: up to week 24 ]

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19. Secondary:

Daily Average in Viral Load Change From Baseline up to Week 48 [ Time Frame: up to week 48 ]

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20. Secondary:

Change From Baseline in CD4+ Cell Count up to Week 48 [ Time Frame: up to week 48 ]

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21. Secondary:

Change From Baseline in log10 Viral Load up to Week 48 [ Time Frame: up to week 48 ]

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22. Secondary:

Occurrence of New AIDS Progression Events or Death [ Time Frame: through 48 weeks of treatment ]

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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 by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:

Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011 Dec 1;11(4):295-302.

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00517192 History of Changes
Other Study ID Numbers:	1182.71
Study First Received:	August 15, 2007
Results First Received:	September 18, 2009
Last Updated:	May 18, 2012
Health Authority:	Belgium: Federal Agency for Medicines and Health Products Canada: Health Canada (TPD) France: AFSSAPS Germany: BfArM-Bundesinstitut fuer Arzneimittel und Medizinprodukte (Federal Authorities for Drugs and Medica Greece: National Organization for Medicines (EOF) National Ethics Committee Italy: Comitato Etico Azienda Spedali Civili di Brescia Portugal: INFARMED I.P. Parque da Saúde de Lisboa Av. do Brasil, nº 53 1749-004 Lisboa Spain: Ministry of Health Thailand: Ministry of Public Health United States: Food and Drug Administration

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