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Clinical Trials/NCT00054717
NCT00054717CompletedPhase 3

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.

Boehringer Ingelheim117 sites in 1 country630 target enrollmentStarted: January 2003Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
630
Locations
117
Primary Endpoint
Treatment Response at Week 48
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Intervention Model
Parallel
Primary Purpose
Treatment

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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.
  • •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 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.

Exclusion Criteria

  • Not provided

Arms & Interventions

Tipranavir(TPV)/low dose ritonavir(r)

Other

Intervention: Tipranavir (Drug)

Tipranavir(TPV)/low dose ritonavir(r)

Other

Intervention: Ritonavir(r) (Drug)

Comparator protease inhibitor(CPI)/low dose ritonavir(r)

Other

Intervention: Ritonavir(r) (Drug)

Comparator protease inhibitor(CPI)/low dose ritonavir(r)

Other

Intervention: Comparator Protease Inhibitor (CPI) (Drug)

Outcomes

Primary Outcomes

Treatment Response at Week 48

Time Frame: At week 48

Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

Time to Treatment Failure Through 48 Weeks of Treatment

Time Frame: Week 48

Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements \<1 log10 below baseline.

Secondary Outcomes

  • Mean Change From Baseline to Week 24 in CD4+ Cell Count(Baseline to Week 24)
  • Mean Change From Baseline to Week 32 in CD4+ Cell Count(Baseline to Week 32)
  • Mean Change From Baseline to Week 88 in CD4+ Cell Count(Baseline to Week 88)
  • Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF(Week 2 through Week 96 (at any point during trial))
  • Virologic Response (VL < 400 Copies/ml) at Week 16(Week 16)
  • Mean Change From Baseline to Week 40 in CD4+ Cell Count(Baseline to Week 40)
  • Mean Change From Baseline to Week 48 in CD4+ Cell Count(Baseline to Week 48)
  • Mean Change From Baseline to Week 56 in CD4+ Cell Count(Baseline to Week 56)
  • Mean Change From Baseline to Week 64 in CD4+ Cell Count(Baseline to Week 64)
  • Mean Change From Baseline to Week 72 in CD4+ Cell Count(Baseline to Week 72)
  • Mean Change From Baseline to Week 80 in CD4+ Cell Count(Baseline to Week 80)
  • Virologic Response (VL < 400 Copies/ml) at Week 72(Week 72)
  • Virologic Response (VL < 400 Copies/ml) at Week 80(Week 80)
  • Virologic Response (VL < 400 Copies/ml) at Week 88(week 88)
  • Virologic Response (VL < 400 Copies/ml) at Week 24(Week 24)
  • Treatment Response at Week 24(Week 24)
  • Treatment Response at Week 2(week 2)
  • Treatment Response at Week 4(week 4)
  • Treatment Response at Week 8(week 8)
  • Treatment Response at Week 16(week 16)
  • Treatment Response at Week 32(Week 32)
  • Treatment Response at Week 40(Week 40)
  • Treatment Response at Week 48(Week 48)
  • Treatment Response at Week 56(week 56)
  • Treatment Response at Week 64(week 64)
  • Virologic Response (VL < 400 Copies/ml) at Week 32(week 32)
  • Virologic Response (VL < 400 Copies/ml) at Week 40(Week 40)
  • Treatment Response at Week 72(Week 72)
  • Treatment Response at Week 80(Week 80)
  • Treatment Response at Week 88(Week 88)
  • Mean Change From Baseline to Week 96 in CD4+ Cell Count(Baseline to Week 96)
  • Virologic Response (VL < 400 Copies/ml) at Week 48(Week 48)
  • Virologic Response (VL < 400 Copies/ml) at Week 56(Week 56)
  • Virologic Response (VL < 400 Copies/ml) at Week 64(Week 64)
  • Treatment Response at Week 96(Week 96)
  • Time to Treatment Failure Through 96 Weeks of Treatment(Week 96)
  • Time to Confirmed Virologic Failure Through 48 Weeks of Treatment(Week 48)
  • Time to Confirmed Virologic Failure Through 96 Weeks of Treatment(Week 96)
  • Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF(Week 2 through Week 96 (at any point during trial))
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 2(Week 2)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 4(Week 4)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 8(Week 8)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 16(Week 16)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 24(Week 24)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 32(Week 32)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 40(Week 40)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 48(Week 48)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 56(Week 56)
  • Virologic Response (Viral Load >= 1 Log Drop) at Week 64(Week 64)
  • Median Change From Baseline in Viral Load to Week 2(Baseline to Week 2)
  • Median Change From Baseline in Viral Load to Week 4(Baseline to Week 4)
  • Median Change From Baseline in Viral Load to Week 8(Baseline to Week 8)
  • Median Change From Baseline in Viral Load to Week 16(Baseline to Week 16)
  • Median Change From Baseline in Viral Load to Week 24(Baseline to Week 24)
  • Median Change From Baseline in Viral Load to Week 32(Baseline to Week 32)
  • Median Change From Baseline in Viral Load to Week 40(Baseline to Week 40)
  • Median Change From Baseline in Viral Load to Week 48(Baseline to Week 48)
  • Median Change From Baseline in Viral Load to Week 56(Baseline to Week 56)
  • Median Change From Baseline in Viral Load to Week 64(Baseline to Week 64)
  • Median Change From Baseline in Viral Load to Week 72(Baseline to Week 72)
  • Median Change From Baseline in Viral Load to Week 80(Baseline to Week 80)
  • Median Change From Baseline in Viral Load to Week 88(Baseline to Week 88)
  • Median Change From Baseline in Viral Load to Week 96(Baseline to Week 96)
  • Mean Change From Baseline to Week 2 in CD4+ Cell Count(Baseline to Week 2)
  • Mean Change From Baseline to Week 4 in CD4+ Cell Count(Baseline to Week 4)
  • Mean Change From Baseline to Week 8 in CD4+ Cell Count(Baseline to Week 8)
  • Mean Change From Baseline to Week 16 in CD4+ Cell Count(Baseline to Week 16)
  • Time to New CDC Class C Progression Event or Death.(after 48 weeks of treatment)
  • Virologic Response (VL < 400 Copies/ml) at Week 2(Week 2)
  • Virologic Response (VL < 400 Copies/ml) at Week 4(Week 4)
  • Virologic Response (VL < 400 Copies/ml) at Week 8(Week 8)
  • Virologic Response (VL < 400 Copies/ml) at Week 96(week 96)
  • Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF(Week 2 through Week 96 (at any point during trial))
  • Virologic Response (VL < 50 Copies/ml) at Week 32(Week 32)
  • Virologic Response (VL < 50 Copies/ml) at Week 40(Week 40)
  • Virologic Response (VL < 50 Copies/ml) at Week 48(Week 48)
  • Virologic Response (VL < 50 Copies/ml) at Week 56(Week 56)
  • Virologic Response (VL < 50 Copies/ml) at Week 64(Week 64)
  • Virologic Response (VL < 50 Copies/ml) at Week 72(Week 72)
  • Virologic Response (VL < 50 Copies/ml) at Week 80(Week 80)
  • Virologic Response (VL < 50 Copies/ml) at Week 88(Week 88)
  • Virologic Response (VL < 50 Copies/ml) at Week 96(Week 96)
  • Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities(240 Weeks)
  • Virologic Response (VL < 50 Copies/ml) at Week 2(Week 2)
  • Virologic Response (VL < 50 Copies/ml) at Week 4(Week 4)
  • Virologic Response (VL < 50 Copies/ml) at Week 8(Week 8)
  • Virologic Response (VL < 50 Copies/ml) at Week 16(Week 16)
  • Virologic Response (VL < 50 Copies/ml) at Week 24(Week 24)

Investigators

Sponsor Class
Industry

Study Sites (117)

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