Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: Tipranavir (with low dose ritonavir); Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

  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
The discrepancy with enrollment number in the protocol section is due to 16 patients not treated. (7 from TPV/r and 9 from CPI/r). These patients were not included in any analyses or results.

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(TPV)/Low Dose Ritonavir(r)	No text entered.
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)	No text entered.

Participant Flow:   Overall Study

	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)
STARTED	438	428
COMPLETED	86	32
NOT COMPLETED	352	396
Adverse Event	84	41
Protocol Violation	23	16
Lost to Follow-up	5	10
Withdrawal by Subject	29	13
Other reason not defined above	211	316

  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(TPV)/Low Dose Ritonavir(r)	No text entered.
Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Tipranavir(TPV)/Low Dose Ritonavir(r)	Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)	Total
Overall Participants Analyzed; [Units: Participants]	435	428	863
Age [1]; [Units: Years]; Mean (Standard Deviation)	42.5 (8.4)	42.9 (8)	42.7 (8.2)
Gender [1]; [Units: Participants]
Female	84	64	148
Male	351	364	715
[1] 3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.

  Outcome Measures

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1. Primary:

Treatment Response at Week 48 [ Time Frame: after 48 weeks of treatment ]

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2. Primary:

Time to Treatment Failure Through 48 Weeks of Treatment [ Time Frame: after 48 weeks of treatment ]

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3. Secondary:

Treatment Response at Week 2 [ Time Frame: week 2 ]

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4. Secondary:

Treatment Response at Week 4 [ Time Frame: week 4 ]

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5. Secondary:

Treatment Response at Week 8 [ Time Frame: week 8 ]

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6. Secondary:

Treatment Response at Week 16 [ Time Frame: week 16 ]

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7. Secondary:

Treatment Response at Week 24 [ Time Frame: Week 24 ]

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8. Secondary:

Treatment Response at Week 32 [ Time Frame: week 32 ]

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9. Secondary:

Treatment Response at Week 40 [ Time Frame: week 40 ]

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10. Secondary:

Treatment Response at Week 56 [ Time Frame: week 56 ]

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11. Secondary:

Treatment Response at Week 64 [ Time Frame: week 64 ]

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12. Secondary:

Treatment Response at Week 72 [ Time Frame: week 72 ]

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13. Secondary:

Treatment Response at Week 80 [ Time Frame: week 80 ]

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14. Secondary:

Treatment Response at Week 88 [ Time Frame: week 88 ]

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15. Secondary:

Treatment Response at Week 96 [ Time Frame: after 96 weeks of treatment ]

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16. Secondary:

Time to Treatment Failure Through 96 Weeks of Treatment [ Time Frame: after 96 weeks of treatment ]

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17. Secondary:

Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [ Time Frame: after 48 weeks of treatment ]

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18. Secondary:

Time to Confirmed Virologic Failure Through 96 Weeks of Treatment [ Time Frame: after 96 weeks of treatment ]

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19. Secondary:

Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

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20. Secondary:

Virologic Response at Week 2 [ Time Frame: Week 2 ]

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21. Secondary:

Virologic Response at Week 4 [ Time Frame: week 4 ]

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22. Secondary:

Virologic Response at Week 8 [ Time Frame: week 8 ]

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23. Secondary:

Virologic Response at Week 16 [ Time Frame: week 16 ]

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24. Secondary:

Virologic Response at Week 24 [ Time Frame: week 24 ]

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25. Secondary:

Virologic Response at Week 32 [ Time Frame: week 32 ]

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26. Secondary:

Virologic Response at Week 40 [ Time Frame: week 40 ]

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27. Secondary:

Virologic Response at Week 48 [ Time Frame: week 48 ]

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28. Secondary:

Virologic Response at Week 56 [ Time Frame: week 56 ]

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29. Secondary:

Virologic Response at Week 64 [ Time Frame: week 64 ]

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30. Secondary:

Virologic Response at Week 72 [ Time Frame: Week 72 ]

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31. Secondary:

Virologic Response at Week 80 [ Time Frame: Week 80 ]

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32. Secondary:

Virologic Response at Week 88 [ Time Frame: Week 88 ]

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33. Secondary:

Virologic Response at Week 96 [ Time Frame: Week 96 ]

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34. Secondary:

Median Change From Baseline in Viral Load (Week 2) [ Time Frame: Baseline to Week 2 ]

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35. Secondary:

Median Change From Baseline in Viral Load (Week 4) [ Time Frame: Baseline to Week 4 ]

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36. Secondary:

Median Change From Baseline in Viral Load (Week 8) [ Time Frame: Baseline to Week 8 ]

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37. Secondary:

Median Change From Baseline in Viral Load (Week 16) [ Time Frame: Baseline to Week 16 ]

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38. Secondary:

Median Change From Baseline in Viral Load (Week 24) [ Time Frame: Baseline to Week 24 ]

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39. Secondary:

Median Change From Baseline in Viral Load (Week 32) [ Time Frame: Baseline to Week 32 ]

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40. Secondary:

Median Change From Baseline in Viral Load (Week 40) [ Time Frame: Baseline to Week 40 ]

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41. Secondary:

Median Change From Baseline in Viral Load (Week 48) [ Time Frame: Baseline to Week 48 ]

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42. Secondary:

Median Change From Baseline in Viral Load (Week 56) [ Time Frame: Baseline to Week 56 ]

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43. Secondary:

Median Change From Baseline in Viral Load (Week 64) [ Time Frame: Baseline to Week 64 ]

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44. Secondary:

Median Change From Baseline in Viral Load (Week 72) [ Time Frame: Baseline to Week 72 ]

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45. Secondary:

Median Change From Baseline in Viral Load (Week 80) [ Time Frame: Baseline to Week 80 ]

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46. Secondary:

Median Change From Baseline in Viral Load (Week 88) [ Time Frame: Baseline to Week 88 ]

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47. Secondary:

Median Change From Baseline in Viral Load (Week 96) [ Time Frame: Baseline to Week 96 ]

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48. Secondary:

Virologic Response at Week 40 [ Time Frame: Week 40 ]

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49. Secondary:

Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

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50. Secondary:

Virologic Response at Week 2 [ Time Frame: Week 2 ]

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51. Secondary:

Virologic Response at Week 4 [ Time Frame: Week 4 ]

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52. Secondary:

Virologic Response at Week 8 [ Time Frame: Week 8 ]

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53. Secondary:

Virologic Response at Week 16 [ Time Frame: Week 16 ]

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54. Secondary:

Virologic Response at Week 24 [ Time Frame: Week 24 ]

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55. Secondary:

Virologic Response at Week 32 [ Time Frame: Week 32 ]

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56. Secondary:

Virologic Response at Week 48 [ Time Frame: Week 48 ]

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57. Secondary:

Virologic Response at Week 56 [ Time Frame: Week 56 ]

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58. Secondary:

Virologic Response at Week 64 [ Time Frame: Week 64 ]

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59. Secondary:

Virologic Response at Week 72 [ Time Frame: Week 72 ]

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60. Secondary:

Virologic Response at Week 80 [ Time Frame: Week 80 ]

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61. Secondary:

Virologic Response at Week 88 [ Time Frame: week 88 ]

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62. Secondary:

Virologic Response at Week 96 [ Time Frame: week 96 ]

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63. Secondary:

Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ]

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64. Secondary:

Virologic Response at Week 2 [ Time Frame: Week 2 ]

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65. Secondary:

Virologic Response at Week 4 [ Time Frame: Week 4 ]

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66. Secondary:

Virologic Response at Week 8 [ Time Frame: Week 8 ]

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67. Secondary:

Virologic Response at Week 16 [ Time Frame: Week 16 ]

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68. Secondary:

Virologic Response at Week 24 [ Time Frame: Week 24 ]

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69. Secondary:

Virologic Response at Week 32 [ Time Frame: Week 32 ]

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70. Secondary:

Virologic Response at Week 40 [ Time Frame: Week 40 ]

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71. Secondary:

Virologic Response at Week 48 [ Time Frame: Week 48 ]

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72. Secondary:

Virologic Response at Week 56 [ Time Frame: Week 56 ]

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73. Secondary:

Virologic Response at Week 64 [ Time Frame: Week 64 ]

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74. Secondary:

Virologic Response at Week 72 [ Time Frame: Week 72 ]

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75. Secondary:

Virologic Response at Week 80 [ Time Frame: Week 80 ]

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76. Secondary:

Virologic Response at Week 88 [ Time Frame: Week 88 ]

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77. Secondary:

Virologic Response at Week 96 [ Time Frame: Week 96 ]

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78. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 2) [ Time Frame: Baseline to Week 2 ]

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79. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 4) [ Time Frame: Baseline to Week 4 ]

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80. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 8) [ Time Frame: Baseline to Week 8 ]

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81. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 16) [ Time Frame: Baseline to Week 16 ]

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82. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 24) [ Time Frame: Baseline to Week 24 ]

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83. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 32) [ Time Frame: Baseline to Week 32 ]

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84. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 40) [ Time Frame: Baseline to Week 40 ]

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85. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 48) [ Time Frame: Baseline to Week 48 ]

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86. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 56) [ Time Frame: Baseline to Week 56 ]

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87. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 64) [ Time Frame: Baseline to Week 64 ]

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88. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 72) [ Time Frame: Baseline to Week 72 ]

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89. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 80) [ Time Frame: Baseline to Week 80 ]

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90. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 88) [ Time Frame: Baseline to Week 88 ]

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91. Secondary:

Mean Change From Baseline in CD4+ Cell Count (Week 96) [ Time Frame: Baseline to Week 96 ]

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92. Secondary:

Time to New Centers for Disease Control (CDC) Class C Progression Event or Death. [ Time Frame: up to 75 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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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.

Results Point of Contact:  

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mikl J, Sulkowski MS, Benhamou Y, Dieterich D, Pol S, Rockstroh J, Robinson PA, Ranga M, Stern JO. Hepatic profile analyses of tipranavir in Phase II and III clinical trials. BMC Infect Dis. 2009 Dec 14;9:203. doi: 10.1186/1471-2334-9-203.

Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D, Valdez H; RESIST investigator group. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006 Aug 5;368(9534):466-75.

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00144170 History of Changes
Other Study ID Numbers:	1182.48; RESIST 2
First Submitted:	September 2, 2005
First Posted:	September 5, 2005
Results First Submitted:	September 11, 2009
Results First Posted:	December 23, 2009
Last Update Posted:	July 2, 2014