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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00054717




Registration number
NCT00054717
Ethics application status
Date submitted
7/02/2003
Date registered
10/02/2003
Date last updated
2/07/2014

Titles & IDs
Public title
Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
Scientific title
Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients.
Secondary ID [1] 0 0
1182.12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other: Tipranavir(TPV)/low dose ritonavir(r) -

Other: Comparator protease inhibitor(CPI)/low dose ritonavir(r) -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Response at Week 48
Timepoint [1] 0 0
At week 48
Primary outcome [2] 0 0
Time to Treatment Failure Through 48 Weeks of Treatment
Timepoint [2] 0 0
Week 48
Secondary outcome [1] 0 0
Treatment Response at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Treatment Response at Week 2
Timepoint [2] 0 0
week 2
Secondary outcome [3] 0 0
Treatment Response at Week 4
Timepoint [3] 0 0
week 4
Secondary outcome [4] 0 0
Treatment Response at Week 8
Timepoint [4] 0 0
week 8
Secondary outcome [5] 0 0
Treatment Response at Week 16
Timepoint [5] 0 0
week 16
Secondary outcome [6] 0 0
Treatment Response at Week 32
Timepoint [6] 0 0
Week 32
Secondary outcome [7] 0 0
Treatment Response at Week 40
Timepoint [7] 0 0
Week 40
Secondary outcome [8] 0 0
Treatment Response at Week 48
Timepoint [8] 0 0
Week 48
Secondary outcome [9] 0 0
Treatment Response at Week 56
Timepoint [9] 0 0
week 56
Secondary outcome [10] 0 0
Treatment Response at Week 64
Timepoint [10] 0 0
week 64
Secondary outcome [11] 0 0
Treatment Response at Week 72
Timepoint [11] 0 0
Week 72
Secondary outcome [12] 0 0
Treatment Response at Week 80
Timepoint [12] 0 0
Week 80
Secondary outcome [13] 0 0
Treatment Response at Week 88
Timepoint [13] 0 0
Week 88
Secondary outcome [14] 0 0
Treatment Response at Week 96
Timepoint [14] 0 0
Week 96
Secondary outcome [15] 0 0
Time to Treatment Failure Through 96 Weeks of Treatment
Timepoint [15] 0 0
Week 96
Secondary outcome [16] 0 0
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Timepoint [16] 0 0
Week 48
Secondary outcome [17] 0 0
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Timepoint [17] 0 0
Week 96
Secondary outcome [18] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF
Timepoint [18] 0 0
Week 2 through Week 96 (at any point during trial)
Secondary outcome [19] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 2
Timepoint [19] 0 0
Week 2
Secondary outcome [20] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 4
Timepoint [20] 0 0
Week 4
Secondary outcome [21] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 8
Timepoint [21] 0 0
Week 8
Secondary outcome [22] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 16
Timepoint [22] 0 0
Week 16
Secondary outcome [23] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 24
Timepoint [23] 0 0
Week 24
Secondary outcome [24] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 32
Timepoint [24] 0 0
Week 32
Secondary outcome [25] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 40
Timepoint [25] 0 0
Week 40
Secondary outcome [26] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 48
Timepoint [26] 0 0
Week 48
Secondary outcome [27] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 56
Timepoint [27] 0 0
Week 56
Secondary outcome [28] 0 0
Virologic Response (Viral Load >= 1 Log Drop) at Week 64
Timepoint [28] 0 0
Week 64
Secondary outcome [29] 0 0
Median Change From Baseline in Viral Load to Week 2
Timepoint [29] 0 0
Baseline to Week 2
Secondary outcome [30] 0 0
Median Change From Baseline in Viral Load to Week 4
Timepoint [30] 0 0
Baseline to Week 4
Secondary outcome [31] 0 0
Median Change From Baseline in Viral Load to Week 8
Timepoint [31] 0 0
Baseline to Week 8
Secondary outcome [32] 0 0
Median Change From Baseline in Viral Load to Week 16
Timepoint [32] 0 0
Baseline to Week 16
Secondary outcome [33] 0 0
Median Change From Baseline in Viral Load to Week 24
Timepoint [33] 0 0
Baseline to Week 24
Secondary outcome [34] 0 0
Median Change From Baseline in Viral Load to Week 32
Timepoint [34] 0 0
Baseline to Week 32
Secondary outcome [35] 0 0
Median Change From Baseline in Viral Load to Week 40
Timepoint [35] 0 0
Baseline to Week 40
Secondary outcome [36] 0 0
Median Change From Baseline in Viral Load to Week 48
Timepoint [36] 0 0
Baseline to Week 48
Secondary outcome [37] 0 0
Median Change From Baseline in Viral Load to Week 56
Timepoint [37] 0 0
Baseline to Week 56
Secondary outcome [38] 0 0
Median Change From Baseline in Viral Load to Week 64
Timepoint [38] 0 0
Baseline to Week 64
Secondary outcome [39] 0 0
Median Change From Baseline in Viral Load to Week 72
Timepoint [39] 0 0
Baseline to Week 72
Secondary outcome [40] 0 0
Median Change From Baseline in Viral Load to Week 80
Timepoint [40] 0 0
Baseline to Week 80
Secondary outcome [41] 0 0
Median Change From Baseline in Viral Load to Week 88
Timepoint [41] 0 0
Baseline to Week 88
Secondary outcome [42] 0 0
Median Change From Baseline in Viral Load to Week 96
Timepoint [42] 0 0
Baseline to Week 96
Secondary outcome [43] 0 0
Mean Change From Baseline to Week 2 in CD4+ Cell Count
Timepoint [43] 0 0
Baseline to Week 2
Secondary outcome [44] 0 0
Mean Change From Baseline to Week 4 in CD4+ Cell Count
Timepoint [44] 0 0
Baseline to Week 4
Secondary outcome [45] 0 0
Mean Change From Baseline to Week 8 in CD4+ Cell Count
Timepoint [45] 0 0
Baseline to Week 8
Secondary outcome [46] 0 0
Mean Change From Baseline to Week 16 in CD4+ Cell Count
Timepoint [46] 0 0
Baseline to Week 16
Secondary outcome [47] 0 0
Mean Change From Baseline to Week 24 in CD4+ Cell Count
Timepoint [47] 0 0
Baseline to Week 24
Secondary outcome [48] 0 0
Mean Change From Baseline to Week 32 in CD4+ Cell Count
Timepoint [48] 0 0
Baseline to Week 32
Secondary outcome [49] 0 0
Mean Change From Baseline to Week 40 in CD4+ Cell Count
Timepoint [49] 0 0
Baseline to Week 40
Secondary outcome [50] 0 0
Mean Change From Baseline to Week 48 in CD4+ Cell Count
Timepoint [50] 0 0
Baseline to Week 48
Secondary outcome [51] 0 0
Mean Change From Baseline to Week 56 in CD4+ Cell Count
Timepoint [51] 0 0
Baseline to Week 56
Secondary outcome [52] 0 0
Mean Change From Baseline to Week 64 in CD4+ Cell Count
Timepoint [52] 0 0
Baseline to Week 64
Secondary outcome [53] 0 0
Mean Change From Baseline to Week 72 in CD4+ Cell Count
Timepoint [53] 0 0
Baseline to Week 72
Secondary outcome [54] 0 0
Mean Change From Baseline to Week 80 in CD4+ Cell Count
Timepoint [54] 0 0
Baseline to Week 80
Secondary outcome [55] 0 0
Mean Change From Baseline to Week 88 in CD4+ Cell Count
Timepoint [55] 0 0
Baseline to Week 88
Secondary outcome [56] 0 0
Mean Change From Baseline to Week 96 in CD4+ Cell Count
Timepoint [56] 0 0
Baseline to Week 96
Secondary outcome [57] 0 0
Time to New CDC Class C Progression Event or Death.
Timepoint [57] 0 0
after 48 weeks of treatment
Secondary outcome [58] 0 0
Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF
Timepoint [58] 0 0
Week 2 through Week 96 (at any point during trial)
Secondary outcome [59] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 2
Timepoint [59] 0 0
Week 2
Secondary outcome [60] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 4
Timepoint [60] 0 0
Week 4
Secondary outcome [61] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 8
Timepoint [61] 0 0
Week 8
Secondary outcome [62] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 16
Timepoint [62] 0 0
Week 16
Secondary outcome [63] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 24
Timepoint [63] 0 0
Week 24
Secondary outcome [64] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 32
Timepoint [64] 0 0
week 32
Secondary outcome [65] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 40
Timepoint [65] 0 0
Week 40
Secondary outcome [66] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 48
Timepoint [66] 0 0
Week 48
Secondary outcome [67] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 56
Timepoint [67] 0 0
Week 56
Secondary outcome [68] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 64
Timepoint [68] 0 0
Week 64
Secondary outcome [69] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 72
Timepoint [69] 0 0
Week 72
Secondary outcome [70] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 80
Timepoint [70] 0 0
Week 80
Secondary outcome [71] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 88
Timepoint [71] 0 0
week 88
Secondary outcome [72] 0 0
Virologic Response (VL < 400 Copies/ml) at Week 96
Timepoint [72] 0 0
week 96
Secondary outcome [73] 0 0
Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF
Timepoint [73] 0 0
Week 2 through Week 96 (at any point during trial)
Secondary outcome [74] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 2
Timepoint [74] 0 0
Week 2
Secondary outcome [75] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 4
Timepoint [75] 0 0
Week 4
Secondary outcome [76] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 8
Timepoint [76] 0 0
Week 8
Secondary outcome [77] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 16
Timepoint [77] 0 0
Week 16
Secondary outcome [78] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 24
Timepoint [78] 0 0
Week 24
Secondary outcome [79] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 32
Timepoint [79] 0 0
Week 32
Secondary outcome [80] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 40
Timepoint [80] 0 0
Week 40
Secondary outcome [81] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 48
Timepoint [81] 0 0
Week 48
Secondary outcome [82] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 56
Timepoint [82] 0 0
Week 56
Secondary outcome [83] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 64
Timepoint [83] 0 0
Week 64
Secondary outcome [84] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 72
Timepoint [84] 0 0
Week 72
Secondary outcome [85] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 80
Timepoint [85] 0 0
Week 80
Secondary outcome [86] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 88
Timepoint [86] 0 0
Week 88
Secondary outcome [87] 0 0
Virologic Response (VL < 50 Copies/ml) at Week 96
Timepoint [87] 0 0
Week 96
Secondary outcome [88] 0 0
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities
Timepoint [88] 0 0
240 Weeks

Eligibility
Key inclusion criteria
Patients meeting the following criteria will be eligible for participation in th is study:

1. Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.
2. Screening genotypic resistance report indicating both of the following: at least one primary protease Inhibitor (PI) mutation at the following sites:

30N, 46I/L, 48V, 50V, 82A/F/L/T, 84V or 90M, and no more than two protease mutations on codons 33, 82, 84, or 90.

3. At least 3 consecutive months experience taking antiretrovirals (ARVs) from each of the classes of nucleoside reverse transcriptase inhibitors(NRTI(s)), non-nucleoside reverse transcriptase inhibitors(NNRTI(s)), and protease inhibitors (PIs) at some point in treatment history,with at least 2 protease inhibitor (PI)-based regimens, one of which must be the current regimen, and current protease inhibitor (PI)-based antiretroviral (ARV) medication regimen for at least 3 months prior to randomization.

4. Human Immunodeficiency Virus 1 (HIV-1) viral load >=1,000 copies/mL at screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Patients with any of the following criteria are excluded from participation in t he study:

1. Antiretroviral (ARV) medication naïve.
2. Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the last 3 months.
3. alanine aminotransferase (ALT) >=3.0x upper limit of normal (ULN) and aspartate aminotransferase(AST) >=2.5x upper limit of normal (ULN) (>=Division of AIDS(DAIDS) Grade 1) at either screening visit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
630
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
1182.12.1401 St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
1182.12.1405 AIDS Research Initiative / Ground Zero - Darlinghurst
Recruitment hospital [3] 0 0
1182.12.1407 Holdsworth House General Practice - Darlinghurst
Recruitment hospital [4] 0 0
1182.12.1408 407 Doctors Pty Ltd. - Darlinghurst
Recruitment hospital [5] 0 0
1182.12.1403 Albion Street Centre - Surry Hills
Recruitment hospital [6] 0 0
1182.12.1406 Gold Coast Sexual Health Clinic - Miami
Recruitment hospital [7] 0 0
1182.12.1404 Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Surry Hills
Recruitment postcode(s) [3] 0 0
- Miami
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nevada
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New Mexico
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Manitoba
Country [36] 0 0
Canada
State/province [36] 0 0
Nova Scotia
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
Puerto Rico
State/province [39] 0 0
Santurce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
Trial website
https://clinicaltrials.gov/study/NCT00054717
Trial related presentations / publications
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. doi: 10.1016/S0140-6736(06)69154-X.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00054717