Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST) - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00054717

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Tipranavir Drug: Ritonavir(r) Drug: Comparitor Protease Inhibitor (CPI)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official 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.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Tipranavir

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Treatment Response at Week 48 [ Time Frame: At week 48 ]
Time to Treatment Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ]

Secondary Outcome Measures:

Treatment Response at Week 24 [ Time Frame: Week 24 ]
Treatment Response at Week 2 [ Time Frame: week 2 ]
Treatment Response at Week 4 [ Time Frame: week 4 ]
Treatment Response at Week 8 [ Time Frame: week 8 ]
Treatment Response at Week 16 [ Time Frame: week 16 ]
Treatment Response at Week 24 [ Time Frame: week 24 ]
Treatment Response at Week 32 [ Time Frame: Week 32 ]
Treatment Response at Week 40 [ Time Frame: Week 40 ]
Treatment Response at Week 48 [ Time Frame: Week 48 ]
Treatment Response at Week 56 [ Time Frame: week 56 ]
Treatment Response at Week 64 [ Time Frame: week 64 ]
Treatment Response at Week 72 [ Time Frame: Week 72 ]
Treatment Response at Week 80 [ Time Frame: Week 80 ]
Treatment Response at Week 88 [ Time Frame: Week 88 ]
Treatment Response at Week 96 [ Time Frame: Week 96 ]
Time to Treatment Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ]
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ]
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment [ Time Frame: Week 96 ]
Virologic Response [ Time Frame: Week 2 through Week 96 (at any point during trial) ]
Virologic Response at Week 2 [ Time Frame: Week 2 ]
Virologic Response at Week 4 [ Time Frame: Week 4 ]
Virologic Response at Week 8 [ Time Frame: Week 8 ]
Virologic Response at Week 16 [ Time Frame: Week 16 ]
Virologic Response at Week 24 [ Time Frame: Week 24 ]
Virologic Response at Week 32 [ Time Frame: Week 32 ]
Virologic Response at Week 40 [ Time Frame: Week 40 ]
Virologic Response at Week 48 [ Time Frame: Week 48 ]
Virologic Response at Week 56 [ Time Frame: Week 56 ]
Virologic Response at Week 64 [ Time Frame: Week 64 ]
Median Change From Baseline in Viral Load to Week 2 [ Time Frame: Baseline to Week 2 ]
Median Change From Baseline in Viral Load to Week 4 [ Time Frame: Baseline to Week 4 ]
Median Change From Baseline in Viral Load to Week 8 [ Time Frame: Baseline to Week 8 ]
Median Change From Baseline in Viral Load to Week 16 [ Time Frame: Baseline to Week 16 ]
Median Change From Baseline in Viral Load to Week 24 [ Time Frame: Baseline to Week 24 ]
Median Change From Baseline in Viral Load to Week 32 [ Time Frame: Baseline to Week 32 ]
Median Change From Baseline in Viral Load to Week 40 [ Time Frame: Baseline to Week 40 ]
Median Change From Baseline in Viral Load to Week 48 [ Time Frame: Baseline to Week 48 ]
Median Change From Baseline in Viral Load to Week 56 [ Time Frame: Baseline to Week 56 ]
Median Change From Baseline in Viral Load to Week 64 [ Time Frame: Baseline to Week 64 ]
Median Change From Baseline in Viral Load to Week 72 [ Time Frame: Baseline to Week 72 ]
Median Change From Baseline in Viral Load to Week 80 [ Time Frame: Baseline to Week 80 ]
Median Change From Baseline in Viral Load to Week 88 [ Time Frame: Baseline to Week 88 ]
Median Change From Baseline in Viral Load to Week 96 [ Time Frame: Baseline to Week 96 ]
Mean Change From Baseline to Week 2 in CD4+ Cell Count [ Time Frame: Baseline to Week 2 ]
Mean Change From Baseline to Week 4 in CD4+ Cell Count [ Time Frame: Baseline to Week 4 ]
Mean Change From Baseline to Week 16 in CD4+ Cell Count [ Time Frame: Baseline to Week 16 ]
Mean Change From Baseline to Week 24 in CD4+ Cell Count [ Time Frame: Baseline to Week 24 ]
Mean Change From Baseline to Week 32 in CD4+ Cell Count [ Time Frame: Baseline to Week 32 ]
Mean Change From Baseline to Week 40 in CD4+ Cell Count [ Time Frame: Baseline to Week 40 ]
Mean Change From Baseline to Week 48 in CD4+ Cell Count [ Time Frame: Baseline to Week 48 ]
Mean Change From Baseline to Week 56 in CD4+ Cell Count [ Time Frame: Baseline to Week 56 ]
Mean Change From Baseline to Week 64 in CD4+ Cell Count [ Time Frame: Baseline to Week 64 ]
Mean Change From Baseline to Week 72 in CD4+ Cell Count [ Time Frame: Baseline to Week 72 ]
Mean Change From Baseline to Week 80 in CD4+ Cell Count [ Time Frame: Baseline to Week 80 ]
Mean Change From Baseline to Week 88 in CD4+ Cell Count [ Time Frame: Baseline to Week 88 ]
Mean Change From Baseline to Week 96 in CD4+ Cell Count [ Time Frame: Baseline to Week 96 ]
Time to New CDC Class C Progression Event or Death. [ Time Frame: after 48 weeks of treatment ]
Virologic Response at Week 32 [ Time Frame: week 32 ]
Virologic Response at Week 72 [ Time Frame: Week 72 ]
Virologic Response at Week 80 [ Time Frame: Week 80 ]
Virologic Response at Week 88 [ Time Frame: week 88 ]
Virologic Response at Week 96 [ Time Frame: week 96 ]
Virologic Response at Week 88 [ Time Frame: Week 88 ]
Virologic Response at Week 96 [ Time Frame: Week 96 ]

Enrollment:	630
Study Start Date:	January 2003
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tipranavir(TPV)/low dose ritonavir(r)	Drug: Tipranavir Drug: Ritonavir(r)
Comparitor protease inhibitor(CPI)/low dose ritonavir(r)	Drug: Ritonavir(r) Drug: Comparitor Protease Inhibitor (CPI)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Human Immunodeficiency virus 1 (HIV-1) infected males or females >=18 years of age.
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.

Exclusion criteria:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054717

Show 117 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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 ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1182.12
Study First Received:	February 7, 2003
Results First Received:	September 9, 2009
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00054717 History of Changes
Health Authority:	Australia: Responsilble Ethics Committee; Canada: Health Canada (TPD); United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Tipranavir
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Ritonavir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 25, 2009