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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tipranavir

Ritonavir(r)

Comparator Protease Inhibitor (CPI)

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Tipranavir(TPV)/low dose ritonavir(r)

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

Arm Description

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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 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 to Confirmed Virologic Failure Through 96 Weeks of Treatment

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Median Change From Baseline in Viral Load to Week 2

Median Change From Baseline in Viral Load to Week 4

Median Change From Baseline in Viral Load to Week 8

Median Change From Baseline in Viral Load to Week 16

Median Change From Baseline in Viral Load to Week 24

Median Change From Baseline in Viral Load to Week 32

Median Change From Baseline in Viral Load to Week 40

Median Change From Baseline in Viral Load to Week 48

Median Change From Baseline in Viral Load to Week 56

Median Change From Baseline in Viral Load to Week 64

Median Change From Baseline in Viral Load to Week 72

Median Change From Baseline in Viral Load to Week 80

Median Change From Baseline in Viral Load to Week 88

Median Change From Baseline in Viral Load to Week 96

Mean Change From Baseline to Week 2 in CD4+ Cell Count

Mean Change From Baseline to Week 4 in CD4+ Cell Count

Mean Change From Baseline to Week 8 in CD4+ Cell Count

Mean Change From Baseline to Week 16 in CD4+ Cell Count

Mean Change From Baseline to Week 24 in CD4+ Cell Count

Mean Change From Baseline to Week 32 in CD4+ Cell Count

Mean Change From Baseline to Week 40 in CD4+ Cell Count

Mean Change From Baseline to Week 48 in CD4+ Cell Count

Mean Change From Baseline to Week 56 in CD4+ Cell Count

Mean Change From Baseline to Week 64 in CD4+ Cell Count

Mean Change From Baseline to Week 72 in CD4+ Cell Count

Mean Change From Baseline to Week 80 in CD4+ Cell Count

Mean Change From Baseline to Week 88 in CD4+ Cell Count

Mean Change From Baseline to Week 96 in CD4+ Cell Count

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

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

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 2

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 4

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 8

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 16

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 24

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 32

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 40

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 48

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 56

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 64

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 72

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 80

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 88

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 400 Copies/ml) at Week 96

Percentage of participants with Viral Load < 400 copies/mL

Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 2

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 4

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 8

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 16

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 24

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 32

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 40

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 48

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 56

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 64

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 72

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 80

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 88

Percentage of participants with Viral Load < 50 copies/mL

Virologic Response (VL < 50 Copies/ml) at Week 96

Percentage of participants with Viral Load < 50 copies/mL

Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities

NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.

Full Information

NCT ID

NCT00054717

First Posted

February 7, 2003

Last Updated

June 23, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00054717

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Enrollment

630 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tipranavir(TPV)/low dose ritonavir(r)

Arm Type

Other

Arm Title

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

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Tipranavir

Intervention Type

Drug

Intervention Name(s)

Ritonavir(r)

Intervention Type

Drug

Intervention Name(s)

Comparator Protease Inhibitor (CPI)

Primary Outcome Measure Information:

Title

Treatment Response at Week 48

Description

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

Title

Time to Treatment Failure Through 48 Weeks of Treatment

Description

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

Treatment Response at Week 24

Description

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

Title

Treatment Response at Week 2

Description

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

Title

Treatment Response at Week 4

Description

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

Title

Treatment Response at Week 8

Description

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 8

Title

Treatment Response at Week 16

Description

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

Title

Treatment Response at Week 32

Description

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

Title

Treatment Response at Week 40

Description

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

Title

Treatment Response at Week 48

Description

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

Title

Treatment Response at Week 56

Description

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

Title

Treatment Response at Week 64

Description

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

Title

Treatment Response at Week 72

Description

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

Title

Treatment Response at Week 80

Description

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

Title

Treatment Response at Week 88

Description

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

Title

Treatment Response at Week 96

Description

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

Title

Time to Treatment Failure Through 96 Weeks of Treatment

Description

Time Frame

Week 96

Title

Time to Confirmed Virologic Failure Through 48 Weeks of Treatment

Description

Time Frame

Week 48

Title

Time to Confirmed Virologic Failure Through 96 Weeks of Treatment

Description

Time Frame

Week 96

Title

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

Description

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

Time Frame

Week 2 through Week 96 (at any point during trial)

Title

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

Description

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

Time Frame

Week 2

Title

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

Description

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

Time Frame

Week 4

Title

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

Description

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

Time Frame

Week 8

Title

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

Description

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

Time Frame

Week 16

Title

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

Description

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

Time Frame

Week 24

Title

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

Description

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

Time Frame

Week 32

Title

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

Description

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

Time Frame

Week 40

Title

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

Description

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

Time Frame

Week 48

Title

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

Description

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

Time Frame

Week 56

Title

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

Description

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

Time Frame

Week 64

Title

Median Change From Baseline in Viral Load to Week 2

Time Frame

Baseline to Week 2

Title

Median Change From Baseline in Viral Load to Week 4

Time Frame

Baseline to Week 4

Title

Median Change From Baseline in Viral Load to Week 8

Time Frame

Baseline to Week 8

Title

Median Change From Baseline in Viral Load to Week 16

Time Frame

Baseline to Week 16

Title

Median Change From Baseline in Viral Load to Week 24

Time Frame

Baseline to Week 24

Title

Median Change From Baseline in Viral Load to Week 32

Time Frame

Baseline to Week 32

Title

Median Change From Baseline in Viral Load to Week 40

Time Frame

Baseline to Week 40

Title

Median Change From Baseline in Viral Load to Week 48

Time Frame

Baseline to Week 48

Title

Median Change From Baseline in Viral Load to Week 56

Time Frame

Baseline to Week 56

Title

Median Change From Baseline in Viral Load to Week 64

Time Frame

Baseline to Week 64

Title

Median Change From Baseline in Viral Load to Week 72

Time Frame

Baseline to Week 72

Title

Median Change From Baseline in Viral Load to Week 80

Time Frame

Baseline to Week 80

Title

Median Change From Baseline in Viral Load to Week 88

Time Frame

Baseline to Week 88

Title

Median Change From Baseline in Viral Load to Week 96

Time Frame

Baseline to Week 96

Title

Mean Change From Baseline to Week 2 in CD4+ Cell Count

Time Frame

Baseline to Week 2

Title

Mean Change From Baseline to Week 4 in CD4+ Cell Count

Time Frame

Baseline to Week 4

Title

Mean Change From Baseline to Week 8 in CD4+ Cell Count

Time Frame

Baseline to Week 8

Title

Mean Change From Baseline to Week 16 in CD4+ Cell Count

Time Frame

Baseline to Week 16

Title

Mean Change From Baseline to Week 24 in CD4+ Cell Count

Time Frame

Baseline to Week 24

Title

Mean Change From Baseline to Week 32 in CD4+ Cell Count

Time Frame

Baseline to Week 32

Title

Mean Change From Baseline to Week 40 in CD4+ Cell Count

Time Frame

Baseline to Week 40

Title

Mean Change From Baseline to Week 48 in CD4+ Cell Count

Time Frame

Baseline to Week 48

Title

Mean Change From Baseline to Week 56 in CD4+ Cell Count

Time Frame

Baseline to Week 56

Title

Mean Change From Baseline to Week 64 in CD4+ Cell Count

Time Frame

Baseline to Week 64

Title

Mean Change From Baseline to Week 72 in CD4+ Cell Count

Time Frame

Baseline to Week 72

Title

Mean Change From Baseline to Week 80 in CD4+ Cell Count

Time Frame

Baseline to Week 80

Title

Mean Change From Baseline to Week 88 in CD4+ Cell Count

Time Frame

Baseline to Week 88

Title

Mean Change From Baseline to Week 96 in CD4+ Cell Count

Time Frame

Baseline to Week 96

Title

Time to New CDC Class C Progression Event or Death.

Description

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

Title

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

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 2 through Week 96 (at any point during trial)

Title

Virologic Response (VL < 400 Copies/ml) at Week 2

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 2

Title

Virologic Response (VL < 400 Copies/ml) at Week 4

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 4

Title

Virologic Response (VL < 400 Copies/ml) at Week 8

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 8

Title

Virologic Response (VL < 400 Copies/ml) at Week 16

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 16

Title

Virologic Response (VL < 400 Copies/ml) at Week 24

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 24

Title

Virologic Response (VL < 400 Copies/ml) at Week 32

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

week 32

Title

Virologic Response (VL < 400 Copies/ml) at Week 40

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 40

Title

Virologic Response (VL < 400 Copies/ml) at Week 48

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 48

Title

Virologic Response (VL < 400 Copies/ml) at Week 56

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 56

Title

Virologic Response (VL < 400 Copies/ml) at Week 64

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 64

Title

Virologic Response (VL < 400 Copies/ml) at Week 72

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 72

Title

Virologic Response (VL < 400 Copies/ml) at Week 80

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

Week 80

Title

Virologic Response (VL < 400 Copies/ml) at Week 88

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

week 88

Title

Virologic Response (VL < 400 Copies/ml) at Week 96

Description

Percentage of participants with Viral Load < 400 copies/mL

Time Frame

week 96

Title

Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 2 through Week 96 (at any point during trial)

Title

Virologic Response (VL < 50 Copies/ml) at Week 2

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 2

Title

Virologic Response (VL < 50 Copies/ml) at Week 4

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 4

Title

Virologic Response (VL < 50 Copies/ml) at Week 8

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 8

Title

Virologic Response (VL < 50 Copies/ml) at Week 16

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 16

Title

Virologic Response (VL < 50 Copies/ml) at Week 24

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 24

Title

Virologic Response (VL < 50 Copies/ml) at Week 32

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 32

Title

Virologic Response (VL < 50 Copies/ml) at Week 40

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 40

Title

Virologic Response (VL < 50 Copies/ml) at Week 48

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 48

Title

Virologic Response (VL < 50 Copies/ml) at Week 56

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 56

Title

Virologic Response (VL < 50 Copies/ml) at Week 64

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 64

Title

Virologic Response (VL < 50 Copies/ml) at Week 72

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 72

Title

Virologic Response (VL < 50 Copies/ml) at Week 80

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 80

Title

Virologic Response (VL < 50 Copies/ml) at Week 88

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 88

Title

Virologic Response (VL < 50 Copies/ml) at Week 96

Description

Percentage of participants with Viral Load < 50 copies/mL

Time Frame

Week 96

Title

Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities

Description

NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.

Time Frame

240 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1182.12.62 Boehringer Ingelheim Investigational Site

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

1182.12.108 El Rio SIA

City

Tucson

State/Province

Arizona

Country

United States

Facility Name

1182.12.9 Boehringer Ingelheim Investigational Site

City

Berkeley

State/Province

California

Country

United States

Facility Name

1182.12.23 Boehringer Ingelheim Investigational Site

City

Beverly Hills

State/Province

California

Country

United States

Facility Name

1182.12.12 Boehringer Ingelheim Investigational Site

City

Fountain Valley

State/Province

California

Country

United States

Facility Name

1182.12.76 Boehringer Ingelheim Investigational Site

City

Long Beach

State/Province

California

Country

United States

Facility Name

1182.12.1 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1182.12.59 David Geffen School of Medicine at UCLA

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1182.12.82 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1182.12.97 Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

1182.12.69 UC Davis Medical Center

City

Sacramento

State/Province

California

Country

United States

Facility Name

1182.12.89 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1182.12.99 Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

1182.12.25 Boehringer Ingelheim Investigational Site

City

San Francisco

State/Province

California

Country

United States

Facility Name

1182.12.5 Boehringer Ingelheim Investigational Site

City

San Francisco

State/Province

California

Country

United States

Facility Name

1182.12.53 Boehringer Ingelheim Investigational Site

City

San Francisco

State/Province

California

Country

United States

Facility Name

1182.12.98 University of Colorado Health Sciences Center

City

Denver

State/Province

Colorado

Country

United States

Facility Name

1182.12.7 Boehringer Ingelheim Investigational Site

City

Norwalk

State/Province

Connecticut

Country

United States

Facility Name

1182.12.103 Boehringer Ingelheim Investigational Site

City

Washington

State/Province

District of Columbia

Country

United States

Facility Name

1182.12.52 Boehringer Ingelheim Investigational Site

City

Washington

State/Province

District of Columbia

Country

United States

Facility Name

1182.12.70

City

Washington

State/Province

District of Columbia

Country

United States

Facility Name

1182.12.79 Boehringer Ingelheim Investigational Site

City

Fort Lauderdale

State/Province

Florida

Country

United States

Facility Name

1182.12.77 Boehringer Ingelheim Investigational Site

City

Fort Myers

State/Province

Florida

Country

United States

Facility Name

1182.12.93 Boehringer Ingelheim Investigational Site

City

Miami Beach

State/Province

Florida

Country

United States

Facility Name

1182.12.45 Boehringer Ingelheim Investigational Site

City

Miami

State/Province

Florida

Country

United States

Facility Name

1182.12.75 CARES Resource

City

Miami

State/Province

Florida

Country

United States

Facility Name

1182.12.85 Boehringer Ingelheim Investigational Site

City

Miami

State/Province

Florida

Country

United States

Facility Name

1182.12.17 Boehringer Ingelheim Investigational Site

City

Orlando

State/Province

Florida

Country

United States

Facility Name

1182.12.90 Boehringer Ingelheim Investigational Site

City

Sarasota

State/Province

Florida

Country

United States

Facility Name

1182.12.63 Boehringer Ingelheim Investigational Site

City

Tampa

State/Province

Florida

Country

United States

Facility Name

1182.12.78 Boehringer Ingelheim Investigational Site

City

Tampa

State/Province

Florida

Country

United States

Facility Name

1182.12.94 Infectious Disease Research Institute

City

Tampa

State/Province

Florida

Country

United States

Facility Name

1182.12.67 Boehringer Ingelheim Investigational Site

City

Vero Beach

State/Province

Florida

Country

United States

Facility Name

1182.12.123 Infectious Disease Clinics of Emory

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

1182.12.88 Boehringer Ingelheim Investigational Site

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

1182.12.72 Boehringer Ingelheim Investigational Site

City

Decatur

State/Province

Georgia

Country

United States

Facility Name

1182.12.47 Boehringer Ingelheim Investigational Site

City

Macon

State/Province

Georgia

Country

United States

Facility Name

1182.12.8 Family Practice Medical Center

City

Boise

State/Province

Idaho

Country

United States

Facility Name

1182.12.105 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

1182.12.3 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

1182.12.49 Boehringer Ingelheim Investigational Site

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

1182.12.32 Boehringer Ingelheim Investigational Site

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

1182.12.48 Boehringer Ingelheim Investigational Site

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

1182.12.33 Boehringer Ingelheim Investigational Site

City

Lexington

State/Province

Kentucky

Country

United States

Facility Name

1182.12.44 Boehringer Ingelheim Investigational Site

City

Louisville

State/Province

Kentucky

Country

United States

Facility Name

1182.12.95 Boehringer Ingelheim Investigational Site

City

New Orleans

State/Province

Louisiana

Country

United States

Facility Name

1182.12.81 Boehringer Ingelheim Investigational Site

City

Portland

State/Province

Maine

Country

United States

Facility Name

1182.12.30 Boehringer Ingelheim Investigational Site

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

1182.12.6 Boehringer Ingelheim Investigational Site

City

Bethesda

State/Province

Maryland

Country

United States

Facility Name

1182.12.100 Boehringer Ingelheim Investigational Site

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

1182.12.101 Boehringer Ingelheim Investigational Site

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

1182.12.41 Boehringer Ingelheim Investigational Site

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

1182.12.61 Boehringer Ingelheim Investigational Site

City

Springfield

State/Province

Massachusetts

Country

United States

Facility Name

1182.12.13 University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

Country

United States

Facility Name

1182.12.54 Boehringer Ingelheim Investigational Site

City

Detroit

State/Province

Michigan

Country

United States

Facility Name

1182.12.56 Boehringer Ingelheim Investigational Site

City

Detroit

State/Province

Michigan

Country

United States

Facility Name

1182.12.120 Department of Medicine, HIV/AIDS Program

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

1182.12.14 Dybedal Center for Clinical Research

City

Kansas City

State/Province

Missouri

Country

United States

Facility Name

1182.12.87 Boehringer Ingelheim Investigational Site

City

St Louis

State/Province

Missouri

Country

United States

Facility Name

1182.12.11 Wellness Center

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

1182.12.4 Boehringer Ingelheim Investigational Site

City

Camden

State/Province

New Jersey

Country

United States

Facility Name

1182.12.21 Boehringer Ingelheim Investigational Site

City

East Orange

State/Province

New Jersey

Country

United States

Facility Name

1182.12.40 Boehringer Ingelheim Investigational Site

City

Santa Fe

State/Province

New Mexico

Country

United States

Facility Name

1182.12.68 Boehringer Ingelheim Investigational Site

City

Albany

State/Province

New York

Country

United States

Facility Name

1182.12.34 Boehringer Ingelheim Investigational Site

City

Mount Vernon

State/Province

New York

Country

United States

Facility Name

1182.12.119 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1182.12.22 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1182.12.36 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1182.12.58 Beth Israel Medical Center

City

New York

State/Province

New York

Country

United States

Facility Name

1182.12.96 Boehringer Ingelheim Investigational Site

City

New York

State/Province

New York

Country

United States

Facility Name

1182.12.107 Boehringer Ingelheim Investigational Site

City

Rochester

State/Province

New York

Country

United States

Facility Name

1182.12.83 Boehringer Ingelheim Investigational Site

City

Stony Brook

State/Province

New York

Country

United States

Facility Name

1182.12.43 Boehringer Ingelheim Investigational Site

City

Valhalla

State/Province

New York

Country

United States

Facility Name

1182.12.42 Boehringer Ingelheim Investigational Site

City

Durham

State/Province

North Carolina

Country

United States

Facility Name

1182.12.46 Boehringer Ingelheim Investigational Site

City

Huntersville

State/Province

North Carolina

Country

United States

Facility Name

1182.12.109 Boehringer Ingelheim Investigational Site

City

Akron

State/Province

Ohio

Country

United States

Facility Name

1182.12.24 Boehringer Ingelheim Investigational Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

1182.12.35 Boehringer Ingelheim Investigational Site

City

Cleveland

State/Province

Ohio

Country

United States

Facility Name

1182.12.65 Ohio State University Medical Center

City

Columbus

State/Province

Ohio

Country

United States

Facility Name

1182.12.80 Infectious Disease Institute Clinical Trials Unit

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

1182.12.114 Pinnacle Health

City

Harrisburg

State/Province

Pennsylvania

Country

United States

Facility Name

1182.12.28 University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1182.12.50 Boehringer Ingelheim Investigational Site

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

1182.12.86 The Miriam Hospital

City

Providence

State/Province

Rhode Island

Country

United States

Facility Name

1182.12.10 Boehringer Ingelheim Investigational Site

City

Columbia

State/Province

South Carolina

Country

United States

Facility Name

1182.12.116 Greenville Hospital System

City

Greenville

State/Province

South Carolina

Country

United States

Facility Name

1182.12.2 Boehringer Ingelheim Investigational Site

City

Memphis

State/Province

Tennessee

Country

United States

Facility Name

1182.12.106 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1182.12.55 Boehringer Ingelheim Investigational Site

City

Dallas

State/Province

Texas

Country

United States

Facility Name

1182.12.31 Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

1182.12.73 Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

1182.12.26 Boehringer Ingelheim Investigational Site

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

1182.12.91 Boehringer Ingelheim Investigational Site

City

Annandale

State/Province

Virginia

Country

United States

Facility Name

1182.12.122 VCU Health Systems

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

1182.12.15 Boehringer Ingelheim Investigational Site

City

Seattle

State/Province

Washington

Country

United States

Facility Name

1182.12.29 Boehringer Ingelheim Investigational Site

City

Milwaukee

State/Province

Wisconsin

Country

United States

Facility Name

1182.12.1401 St. Vincent's Hospital

City

Darlinghurst

State/Province

New South Wales

Country

Australia

Facility Name

1182.12.1405 AIDS Research Initiative / Ground Zero

City

Darlinghurst

State/Province

New South Wales

Country

Australia

Facility Name

1182.12.1407 Holdsworth House General Practice

City

Darlinghurst

State/Province

New South Wales

Country

Australia

Facility Name

1182.12.1408 407 Doctors Pty Ltd.

City

Darlinghurst

State/Province

New South Wales

Country

Australia

Facility Name

1182.12.1403 Albion Street Centre

City

Surry Hills

State/Province

New South Wales

Country

Australia

Facility Name

1182.12.1406 Gold Coast Sexual Health Clinic

City

Miami

State/Province

Queensland

Country

Australia

Facility Name

1182.12.1404 Alfred Hospital

City

Melbourne

State/Province

Victoria

Country

Australia

Facility Name

1182.12.11002 Boehringer Ingelheim Investigational Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

1182.12.11010 Boehringer Ingelheim Investigational Site

City

Winnipeg

State/Province

Manitoba

Country

Canada

Facility Name

1182.12.11016 Boehringer Ingelheim Investigational Site

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

1182.12.11012 Boehringer Ingelheim Investigational Site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

1182.12.11001 Boehringer Ingelheim Investigational Site

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

1182.12.11004 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1182.12.11006 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1182.12.11009 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1182.12.11014 Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

1182.12.11015 Boehringer Ingelheim Investigational Site

City

Monteal

State/Province

Quebec

Country

Canada

Facility Name

1182.12.11003 Boehringer Ingelheim Investigational Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

1182.12.11007 Boehringer Ingelheim Investigational Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

1182.12.11013 Boehringer Ingelheim Investigational Site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

1182.12.60 Boehringer Ingelheim Investigational Site

City

Santurce

Country

Puerto Rico

12. IPD Sharing Statement

Citations:

PubMed Identifier

16890833

Citation

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.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.12_U09-3075-01-DS.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1182/1182.12_literature.pdf

Description

Related Info

Learn more about this trial

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

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

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial