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

June 23, 2014 updated by: Boehringer Ingelheim

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

630

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia
        • 1182.12.1401 St. Vincent's Hospital
      • Darlinghurst, New South Wales, Australia
        • 1182.12.1405 AIDS Research Initiative / Ground Zero
      • Darlinghurst, New South Wales, Australia
        • 1182.12.1407 Holdsworth House General Practice
      • Darlinghurst, New South Wales, Australia
        • 1182.12.1408 407 Doctors Pty Ltd.
      • Surry Hills, New South Wales, Australia
        • 1182.12.1403 Albion Street Centre
    • Queensland
      • Miami, Queensland, Australia
        • 1182.12.1406 Gold Coast Sexual Health Clinic
    • Victoria
      • Melbourne, Victoria, Australia
        • 1182.12.1404 Alfred Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • 1182.12.11002 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 1182.12.11010 Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 1182.12.11016 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • 1182.12.11012 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, Canada
        • 1182.12.11001 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1182.12.11004 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1182.12.11006 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1182.12.11009 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, Canada
        • 1182.12.11014 Boehringer Ingelheim Investigational Site
    • Quebec
      • Monteal, Quebec, Canada
        • 1182.12.11015 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1182.12.11003 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1182.12.11007 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 1182.12.11013 Boehringer Ingelheim Investigational Site
  • Puerto Rico
      • Santurce, Puerto Rico
        • 1182.12.60 Boehringer Ingelheim Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • 1182.12.62 Boehringer Ingelheim Investigational Site
      • Tucson, Arizona, United States
        • 1182.12.108 El Rio SIA
    • California
      • Berkeley, California, United States
        • 1182.12.9 Boehringer Ingelheim Investigational Site
      • Beverly Hills, California, United States
        • 1182.12.23 Boehringer Ingelheim Investigational Site
      • Fountain Valley, California, United States
        • 1182.12.12 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1182.12.76 Boehringer Ingelheim Investigational Site
      • Los Angeles, 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
      • Sacramento, California, United States
        • 1182.12.69 UC Davis Medical Center
      • San Diego, California, United States
        • 1182.12.89 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 1182.12.99 Boehringer Ingelheim Investigational Site
      • San Francisco, California, United States
        • 1182.12.25 Boehringer Ingelheim Investigational Site
      • San Francisco, California, United States
        • 1182.12.5 Boehringer Ingelheim Investigational Site
      • San Francisco, California, United States
        • 1182.12.53 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, United States
        • 1182.12.98 University of Colorado Health Sciences Center
    • Connecticut
      • Norwalk, Connecticut, United States
        • 1182.12.7 Boehringer Ingelheim Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • 1182.12.103 Boehringer Ingelheim Investigational Site
      • Washington, District of Columbia, United States
        • 1182.12.52 Boehringer Ingelheim Investigational Site
      • Washington, District of Columbia, United States
        • 1182.12.70
    • Florida
      • Fort Lauderdale, Florida, United States
        • 1182.12.79 Boehringer Ingelheim Investigational Site
      • Fort Myers, Florida, United States
        • 1182.12.77 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1182.12.45 Boehringer Ingelheim Investigational Site
      • Miami, Florida, United States
        • 1182.12.75 CARES Resource
      • Miami, Florida, United States
        • 1182.12.85 Boehringer Ingelheim Investigational Site
      • Miami Beach, Florida, United States
        • 1182.12.93 Boehringer Ingelheim Investigational Site
      • Orlando, Florida, United States
        • 1182.12.17 Boehringer Ingelheim Investigational Site
      • Sarasota, Florida, United States
        • 1182.12.90 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 1182.12.63 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 1182.12.78 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • 1182.12.94 Infectious Disease Research Institute
      • Vero Beach, Florida, United States
        • 1182.12.67 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, United States
        • 1182.12.123 Infectious Disease Clinics of Emory
      • Atlanta, Georgia, United States
        • 1182.12.88 Boehringer Ingelheim Investigational Site
      • Decatur, Georgia, United States
        • 1182.12.72 Boehringer Ingelheim Investigational Site
      • Macon, Georgia, United States
        • 1182.12.47 Boehringer Ingelheim Investigational Site
    • Idaho
      • Boise, Idaho, United States
        • 1182.12.8 Family Practice Medical Center
    • Illinois
      • Chicago, Illinois, United States
        • 1182.12.105 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 1182.12.3 Boehringer Ingelheim Investigational Site
      • Chicago, Illinois, United States
        • 1182.12.49 Boehringer Ingelheim Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States
        • 1182.12.32 Boehringer Ingelheim Investigational Site
      • Indianapolis, Indiana, United States
        • 1182.12.48 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States
        • 1182.12.33 Boehringer Ingelheim Investigational Site
      • Louisville, Kentucky, United States
        • 1182.12.44 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • 1182.12.95 Boehringer Ingelheim Investigational Site
    • Maine
      • Portland, Maine, United States
        • 1182.12.81 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore, Maryland, United States
        • 1182.12.30 Boehringer Ingelheim Investigational Site
      • Bethesda, Maryland, United States
        • 1182.12.6 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • 1182.12.100 Boehringer Ingelheim Investigational Site
      • Boston, Massachusetts, United States
        • 1182.12.101 Boehringer Ingelheim Investigational Site
      • Boston, Massachusetts, United States
        • 1182.12.41 Boehringer Ingelheim Investigational Site
      • Springfield, Massachusetts, United States
        • 1182.12.61 Boehringer Ingelheim Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • 1182.12.13 University of Michigan Health System
      • Detroit, Michigan, United States
        • 1182.12.54 Boehringer Ingelheim Investigational Site
      • Detroit, Michigan, United States
        • 1182.12.56 Boehringer Ingelheim Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • 1182.12.120 Department of Medicine, HIV/AIDS Program
    • Missouri
      • Kansas City, Missouri, United States
        • 1182.12.14 Dybedal Center for Clinical Research
      • St Louis, Missouri, United States
        • 1182.12.87 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 1182.12.11 Wellness Center
    • New Jersey
      • Camden, New Jersey, United States
        • 1182.12.4 Boehringer Ingelheim Investigational Site
      • East Orange, New Jersey, United States
        • 1182.12.21 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Santa Fe, New Mexico, United States
        • 1182.12.40 Boehringer Ingelheim Investigational Site
    • New York
      • Albany, New York, United States
        • 1182.12.68 Boehringer Ingelheim Investigational Site
      • Mount Vernon, New York, United States
        • 1182.12.34 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 1182.12.119 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 1182.12.22 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 1182.12.36 Boehringer Ingelheim Investigational Site
      • New York, New York, United States
        • 1182.12.58 Beth Israel Medical Center
      • New York, New York, United States
        • 1182.12.96 Boehringer Ingelheim Investigational Site
      • Rochester, New York, United States
        • 1182.12.107 Boehringer Ingelheim Investigational Site
      • Stony Brook, New York, United States
        • 1182.12.83 Boehringer Ingelheim Investigational Site
      • Valhalla, New York, United States
        • 1182.12.43 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Durham, North Carolina, United States
        • 1182.12.42 Boehringer Ingelheim Investigational Site
      • Huntersville, North Carolina, United States
        • 1182.12.46 Boehringer Ingelheim Investigational Site
    • Ohio
      • Akron, Ohio, United States
        • 1182.12.109 Boehringer Ingelheim Investigational Site
      • Cincinnati, Ohio, United States
        • 1182.12.24 Boehringer Ingelheim Investigational Site
      • Cleveland, Ohio, United States
        • 1182.12.35 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 1182.12.65 Ohio State University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 1182.12.80 Infectious Disease Institute Clinical Trials Unit
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States
        • 1182.12.114 Pinnacle Health
      • Philadelphia, Pennsylvania, United States
        • 1182.12.28 University of Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 1182.12.50 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • 1182.12.86 The Miriam Hospital
    • South Carolina
      • Columbia, South Carolina, United States
        • 1182.12.10 Boehringer Ingelheim Investigational Site
      • Greenville, South Carolina, United States
        • 1182.12.116 Greenville Hospital System
    • Tennessee
      • Memphis, Tennessee, United States
        • 1182.12.2 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas, Texas, United States
        • 1182.12.106 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, United States
        • 1182.12.55 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1182.12.31 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1182.12.73 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1182.12.26 Boehringer Ingelheim Investigational Site
    • Virginia
      • Annandale, Virginia, United States
        • 1182.12.91 Boehringer Ingelheim Investigational Site
      • Richmond, Virginia, United States
        • 1182.12.122 VCU Health Systems
    • Washington
      • Seattle, Washington, United States
        • 1182.12.15 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • 1182.12.29 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tipranavir(TPV)/low dose ritonavir(r)
Drug: Tipranavir
Drug: Ritonavir(r)
Other: Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Drug: Ritonavir(r)
Drug: Comparator Protease Inhibitor (CPI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At week 48
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.
Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Response at Week 24
Time Frame: 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
Week 24
Treatment Response at Week 2
Time Frame: 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
week 2
Treatment Response at Week 4
Time Frame: 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
week 4
Treatment Response at Week 8
Time Frame: 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
week 8
Treatment Response at Week 16
Time Frame: 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
week 16
Treatment Response at Week 32
Time Frame: 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
Week 32
Treatment Response at Week 40
Time Frame: 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
Week 40
Treatment Response at Week 48
Time Frame: 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
Week 48
Treatment Response at Week 56
Time Frame: 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
week 56
Treatment Response at Week 64
Time Frame: 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
week 64
Treatment Response at Week 72
Time Frame: 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
Week 72
Treatment Response at Week 80
Time Frame: 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
Week 80
Treatment Response at Week 88
Time Frame: 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
Week 88
Treatment Response at Week 96
Time Frame: 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
Week 96
Time to Treatment Failure Through 96 Weeks of Treatment
Time Frame: Week 96
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.
Week 96
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Time Frame: Week 48
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.
Week 48
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Time Frame: Week 96
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.
Week 96
Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF
Time Frame: Week 2 through Week 96 (at any point during trial)
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 2 through Week 96 (at any point during trial)
Virologic Response (Viral Load >= 1 Log Drop) at Week 2
Time Frame: Week 2
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 2
Virologic Response (Viral Load >= 1 Log Drop) at Week 4
Time Frame: Week 4
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 4
Virologic Response (Viral Load >= 1 Log Drop) at Week 8
Time Frame: Week 8
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 8
Virologic Response (Viral Load >= 1 Log Drop) at Week 16
Time Frame: Week 16
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 16
Virologic Response (Viral Load >= 1 Log Drop) at Week 24
Time Frame: Week 24
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 24
Virologic Response (Viral Load >= 1 Log Drop) at Week 32
Time Frame: Week 32
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 32
Virologic Response (Viral Load >= 1 Log Drop) at Week 40
Time Frame: Week 40
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 40
Virologic Response (Viral Load >= 1 Log Drop) at Week 48
Time Frame: Week 48
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 48
Virologic Response (Viral Load >= 1 Log Drop) at Week 56
Time Frame: Week 56
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 56
Virologic Response (Viral Load >= 1 Log Drop) at Week 64
Time Frame: Week 64
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Week 64
Median Change From Baseline in Viral Load to Week 2
Time Frame: Baseline to Week 2
Baseline to Week 2
Median Change From Baseline in Viral Load to Week 4
Time Frame: Baseline to Week 4
Baseline to Week 4
Median Change From Baseline in Viral Load to Week 8
Time Frame: Baseline to Week 8
Baseline to Week 8
Median Change From Baseline in Viral Load to Week 16
Time Frame: Baseline to Week 16
Baseline to Week 16
Median Change From Baseline in Viral Load to Week 24
Time Frame: Baseline to Week 24
Baseline to Week 24
Median Change From Baseline in Viral Load to Week 32
Time Frame: Baseline to Week 32
Baseline to Week 32
Median Change From Baseline in Viral Load to Week 40
Time Frame: Baseline to Week 40
Baseline to Week 40
Median Change From Baseline in Viral Load to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Median Change From Baseline in Viral Load to Week 56
Time Frame: Baseline to Week 56
Baseline to Week 56
Median Change From Baseline in Viral Load to Week 64
Time Frame: Baseline to Week 64
Baseline to Week 64
Median Change From Baseline in Viral Load to Week 72
Time Frame: Baseline to Week 72
Baseline to Week 72
Median Change From Baseline in Viral Load to Week 80
Time Frame: Baseline to Week 80
Baseline to Week 80
Median Change From Baseline in Viral Load to Week 88
Time Frame: Baseline to Week 88
Baseline to Week 88
Median Change From Baseline in Viral Load to Week 96
Time Frame: Baseline to Week 96
Baseline to Week 96
Mean Change From Baseline to Week 2 in CD4+ Cell Count
Time Frame: Baseline to Week 2
Baseline to Week 2
Mean Change From Baseline to Week 4 in CD4+ Cell Count
Time Frame: Baseline to Week 4
Baseline to Week 4
Mean Change From Baseline to Week 8 in CD4+ Cell Count
Time Frame: Baseline to Week 8
Baseline to Week 8
Mean Change From Baseline to Week 16 in CD4+ Cell Count
Time Frame: Baseline to Week 16
Baseline to Week 16
Mean Change From Baseline to Week 24 in CD4+ Cell Count
Time Frame: Baseline to Week 24
Baseline to Week 24
Mean Change From Baseline to Week 32 in CD4+ Cell Count
Time Frame: Baseline to Week 32
Baseline to Week 32
Mean Change From Baseline to Week 40 in CD4+ Cell Count
Time Frame: Baseline to Week 40
Baseline to Week 40
Mean Change From Baseline to Week 48 in CD4+ Cell Count
Time Frame: Baseline to Week 48
Baseline to Week 48
Mean Change From Baseline to Week 56 in CD4+ Cell Count
Time Frame: Baseline to Week 56
Baseline to Week 56
Mean Change From Baseline to Week 64 in CD4+ Cell Count
Time Frame: Baseline to Week 64
Baseline to Week 64
Mean Change From Baseline to Week 72 in CD4+ Cell Count
Time Frame: Baseline to Week 72
Baseline to Week 72
Mean Change From Baseline to Week 80 in CD4+ Cell Count
Time Frame: Baseline to Week 80
Baseline to Week 80
Mean Change From Baseline to Week 88 in CD4+ Cell Count
Time Frame: Baseline to Week 88
Baseline to Week 88
Mean Change From Baseline to Week 96 in CD4+ Cell Count
Time Frame: Baseline to Week 96
Baseline to Week 96
Time to New CDC Class C Progression Event or Death.
Time Frame: after 48 weeks of treatment
Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death
after 48 weeks of treatment
Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF
Time Frame: Week 2 through Week 96 (at any point during trial)
Percentage of participants with Viral Load < 400 copies/mL
Week 2 through Week 96 (at any point during trial)
Virologic Response (VL < 400 Copies/ml) at Week 2
Time Frame: Week 2
Percentage of participants with Viral Load < 400 copies/mL
Week 2
Virologic Response (VL < 400 Copies/ml) at Week 4
Time Frame: Week 4
Percentage of participants with Viral Load < 400 copies/mL
Week 4
Virologic Response (VL < 400 Copies/ml) at Week 8
Time Frame: Week 8
Percentage of participants with Viral Load < 400 copies/mL
Week 8
Virologic Response (VL < 400 Copies/ml) at Week 16
Time Frame: Week 16
Percentage of participants with Viral Load < 400 copies/mL
Week 16
Virologic Response (VL < 400 Copies/ml) at Week 24
Time Frame: Week 24
Percentage of participants with Viral Load < 400 copies/mL
Week 24
Virologic Response (VL < 400 Copies/ml) at Week 32
Time Frame: week 32
Percentage of participants with Viral Load < 400 copies/mL
week 32
Virologic Response (VL < 400 Copies/ml) at Week 40
Time Frame: Week 40
Percentage of participants with Viral Load < 400 copies/mL
Week 40
Virologic Response (VL < 400 Copies/ml) at Week 48
Time Frame: Week 48
Percentage of participants with Viral Load < 400 copies/mL
Week 48
Virologic Response (VL < 400 Copies/ml) at Week 56
Time Frame: Week 56
Percentage of participants with Viral Load < 400 copies/mL
Week 56
Virologic Response (VL < 400 Copies/ml) at Week 64
Time Frame: Week 64
Percentage of participants with Viral Load < 400 copies/mL
Week 64
Virologic Response (VL < 400 Copies/ml) at Week 72
Time Frame: Week 72
Percentage of participants with Viral Load < 400 copies/mL
Week 72
Virologic Response (VL < 400 Copies/ml) at Week 80
Time Frame: Week 80
Percentage of participants with Viral Load < 400 copies/mL
Week 80
Virologic Response (VL < 400 Copies/ml) at Week 88
Time Frame: week 88
Percentage of participants with Viral Load < 400 copies/mL
week 88
Virologic Response (VL < 400 Copies/ml) at Week 96
Time Frame: week 96
Percentage of participants with Viral Load < 400 copies/mL
week 96
Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF
Time Frame: Week 2 through Week 96 (at any point during trial)
Percentage of participants with Viral Load < 50 copies/mL
Week 2 through Week 96 (at any point during trial)
Virologic Response (VL < 50 Copies/ml) at Week 2
Time Frame: Week 2
Percentage of participants with Viral Load < 50 copies/mL
Week 2
Virologic Response (VL < 50 Copies/ml) at Week 4
Time Frame: Week 4
Percentage of participants with Viral Load < 50 copies/mL
Week 4
Virologic Response (VL < 50 Copies/ml) at Week 8
Time Frame: Week 8
Percentage of participants with Viral Load < 50 copies/mL
Week 8
Virologic Response (VL < 50 Copies/ml) at Week 16
Time Frame: Week 16
Percentage of participants with Viral Load < 50 copies/mL
Week 16
Virologic Response (VL < 50 Copies/ml) at Week 24
Time Frame: Week 24
Percentage of participants with Viral Load < 50 copies/mL
Week 24
Virologic Response (VL < 50 Copies/ml) at Week 32
Time Frame: Week 32
Percentage of participants with Viral Load < 50 copies/mL
Week 32
Virologic Response (VL < 50 Copies/ml) at Week 40
Time Frame: Week 40
Percentage of participants with Viral Load < 50 copies/mL
Week 40
Virologic Response (VL < 50 Copies/ml) at Week 48
Time Frame: Week 48
Percentage of participants with Viral Load < 50 copies/mL
Week 48
Virologic Response (VL < 50 Copies/ml) at Week 56
Time Frame: Week 56
Percentage of participants with Viral Load < 50 copies/mL
Week 56
Virologic Response (VL < 50 Copies/ml) at Week 64
Time Frame: Week 64
Percentage of participants with Viral Load < 50 copies/mL
Week 64
Virologic Response (VL < 50 Copies/ml) at Week 72
Time Frame: Week 72
Percentage of participants with Viral Load < 50 copies/mL
Week 72
Virologic Response (VL < 50 Copies/ml) at Week 80
Time Frame: Week 80
Percentage of participants with Viral Load < 50 copies/mL
Week 80
Virologic Response (VL < 50 Copies/ml) at Week 88
Time Frame: Week 88
Percentage of participants with Viral Load < 50 copies/mL
Week 88
Virologic Response (VL < 50 Copies/ml) at Week 96
Time Frame: Week 96
Percentage of participants with Viral Load < 50 copies/mL
Week 96
Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities
Time Frame: 240 Weeks
NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.
240 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 7, 2003

First Submitted That Met QC Criteria

February 7, 2003

First Posted (Estimate)

February 10, 2003

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1182.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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