Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)

Boehringer Ingelheim630 enrolled

Overview

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

630

Conditions

HIV Infections

Interventions

TipranavirDRUG

Ritonavir(r)DRUG

Comparator Protease Inhibitor (CPI)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. 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.

Locations (117)

Outcomes

Primary Outcomes

Treatment Response 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 frame: At week 48

Time to Treatment Failure Through 48 Weeks of Treatment

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.

Time frame: Week 48

Secondary Outcomes

Treatment Response at Week 24

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 frame: Week 24

Treatment Response at Week 2

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 frame: week 2

Treatment Response at Week 4

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 frame: week 4

Treatment Response at Week 8

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

Data from ClinicalTrials.gov

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1182.12.62 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

1182.12.108 El Rio SIA

Tucson, Arizona, United States

1182.12.9 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

1182.12.23 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

1182.12.12 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

1182.12.76 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

1182.12.1 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1182.12.59 David Geffen School of Medicine at UCLA

Los Angeles, California, United States

1182.12.82 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

1182.12.97 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

...and 107 more locations

Treatment Response at Week 16

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 frame: week 16

Treatment Response at Week 32

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 frame: Week 32

Treatment Response at Week 40

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 frame: Week 40

Treatment Response 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 frame: Week 48

Treatment Response at Week 56

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 frame: week 56

Treatment Response at Week 64

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 frame: week 64

Treatment Response at Week 72

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 frame: Week 72

Treatment Response at Week 80

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 frame: Week 80

Treatment Response at Week 88

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 frame: Week 88

Treatment Response at Week 96

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 frame: Week 96

Time to Treatment Failure Through 96 Weeks of Treatment

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.

Time frame: Week 96

Time to Confirmed Virologic Failure Through 48 Weeks of Treatment

Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.

Time frame: Week 48

Time to Confirmed Virologic Failure Through 96 Weeks of Treatment

Time frame: Week 96

Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 2 through Week 96 (at any point during trial)

Virologic Response (Viral Load >= 1 Log Drop) at Week 2

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 2

Virologic Response (Viral Load >= 1 Log Drop) at Week 4

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 4

Virologic Response (Viral Load >= 1 Log Drop) at Week 8

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 8

Virologic Response (Viral Load >= 1 Log Drop) at Week 16

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 16

Virologic Response (Viral Load >= 1 Log Drop) at Week 24

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 24

Virologic Response (Viral Load >= 1 Log Drop) at Week 32

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 32

Virologic Response (Viral Load >= 1 Log Drop) at Week 40

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 40

Virologic Response (Viral Load >= 1 Log Drop) at Week 48

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 48

Virologic Response (Viral Load >= 1 Log Drop) at Week 56

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

Time frame: Week 56

Virologic Response (Viral Load >= 1 Log Drop) at Week 64

Percentage of participants with Viral Load (VL) \>= 1 log reduction from baseline

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 8 in CD4+ Cell Count

Time frame: Baseline to Week 8

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 to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death

Time frame: after 48 weeks of treatment

Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF