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

ClinicalTrials.gov Identifier:

NCT00517192

First received: August 15, 2007

Last updated: April 25, 2014

Last verified: April 2014

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	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

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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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	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
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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Measure Type	Secondary
Measure Title	Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF
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.
No text entered.

Reporting Groups

	Description
Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

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 VL < 400 Copies/mL Using NCF

No statistical analysis provided for Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF

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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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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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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