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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00054717
First received: February 7, 2003
Last updated: June 23, 2014
Last verified: April 2014
  Purpose

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.


Condition Intervention Phase
HIV Infections
Drug: Tipranavir
Drug: Ritonavir(r)
Drug: Comparator Protease Inhibitor (CPI)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Treatment Response at Week 48 [ Time Frame: At week 48 ] [ Designated as safety issue: No ]
    Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound

  • Time to Treatment Failure Through 48 Weeks of Treatment [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 16 ] [ Designated as safety issue: No ]
    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 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 64 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    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 Frame: Week 96 ] [ Designated as safety issue: No ]
    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 Frame: Week 48 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    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.

  • Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Virologic Response (Viral Load >= 1 Log Drop) at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline

  • Median Change From Baseline in Viral Load to Week 2 [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 4 [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 16 [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 32 [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 40 [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 56 [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 64 [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 72 [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 80 [ Time Frame: Baseline to Week 80 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 88 [ Time Frame: Baseline to Week 88 ] [ Designated as safety issue: No ]
  • Median Change From Baseline in Viral Load to Week 96 [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 2 in CD4+ Cell Count [ Time Frame: Baseline to Week 2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 4 in CD4+ Cell Count [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 8 in CD4+ Cell Count [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 16 in CD4+ Cell Count [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 24 in CD4+ Cell Count [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 32 in CD4+ Cell Count [ Time Frame: Baseline to Week 32 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 40 in CD4+ Cell Count [ Time Frame: Baseline to Week 40 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 48 in CD4+ Cell Count [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 56 in CD4+ Cell Count [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 64 in CD4+ Cell Count [ Time Frame: Baseline to Week 64 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 72 in CD4+ Cell Count [ Time Frame: Baseline to Week 72 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 80 in CD4+ Cell Count [ Time Frame: Baseline to Week 80 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 88 in CD4+ Cell Count [ Time Frame: Baseline to Week 88 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline to Week 96 in CD4+ Cell Count [ Time Frame: Baseline to Week 96 ] [ Designated as safety issue: No ]
  • Time to New CDC Class C Progression Event or Death. [ Time Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 32 [ Time Frame: week 32 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 88 [ Time Frame: week 88 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 400 Copies/ml) at Week 96 [ Time Frame: week 96 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 400 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF [ Time Frame: Week 2 through Week 96 (at any point during trial) ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 40 [ Time Frame: Week 40 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 64 [ Time Frame: Week 64 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 80 [ Time Frame: Week 80 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 88 [ Time Frame: Week 88 ] [ Designated as safety issue: No ]
    Percentage of participants with Viral Load < 50 copies/mL

  • Virologic Response (VL < 50 Copies/ml) at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 240 Weeks ] [ Designated as safety issue: No ]
    NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.


Enrollment: 630
Study Start Date: January 2003
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tipranavir(TPV)/low dose ritonavir(r) Drug: Tipranavir Drug: Ritonavir(r)
Comparator protease inhibitor(CPI)/low dose ritonavir(r) Drug: Ritonavir(r) Drug: Comparator Protease Inhibitor (CPI)

  Eligibility

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

Inclusion Criteria:

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

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
1182.12.62 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
1182.12.108 El Rio SIA
Tucson, Arizona, United States
United States, California
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
1182.12.59 David Geffen School of Medicine at UCLA
Los Angeles, California, United States
1182.12.1 Boehringer Ingelheim Investigational Site
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
1182.12.69 UC Davis Medical Center
Sacramento, California, United States
1182.12.99 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1182.12.89 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1182.12.53 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
United States, Colorado
1182.12.98 University of Colorado Health Sciences Center
Denver, Colorado, United States
United States, Connecticut
1182.12.7 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut, United States
United States, District of Columbia
1182.12.52 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
1182.12.70
Washington, District of Columbia, United States
1182.12.103 Boehringer Ingelheim Investigational Site
Washington, District of Columbia, United States
United States, Florida
1182.12.79 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
1182.12.77 Boehringer Ingelheim Investigational Site
Fort Myers, Florida, United States
1182.12.45 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1182.12.85 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1182.12.75 CARES Resource
Miami, Florida, United States
1182.12.93 Boehringer Ingelheim Investigational Site
Miami Beach, Florida, United States
1182.12.17 Boehringer Ingelheim Investigational Site
Orlando, Florida, United States
1182.12.90 Boehringer Ingelheim Investigational Site
Sarasota, 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
Tampa, Florida, United States
1182.12.67 Boehringer Ingelheim Investigational Site
Vero Beach, Florida, United States
United States, Georgia
1182.12.88 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1182.12.123 Infectious Disease Clinics of Emory
Atlanta, Georgia, United States
1182.12.72 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
1182.12.47 Boehringer Ingelheim Investigational Site
Macon, Georgia, United States
United States, Idaho
1182.12.8 Family Practice Medical Center
Boise, Idaho, United States
United States, Illinois
1182.12.49 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1182.12.3 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1182.12.105 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Indiana
1182.12.48 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
1182.12.32 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
United States, Kentucky
1182.12.33 Boehringer Ingelheim Investigational Site
Lexington, Kentucky, United States
1182.12.44 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Louisiana
1182.12.95 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
United States, Maine
1182.12.81 Boehringer Ingelheim Investigational Site
Portland, Maine, United States
United States, Maryland
1182.12.30 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
1182.12.6 Boehringer Ingelheim Investigational Site
Bethesda, Maryland, United States
United States, Massachusetts
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
Boston, Massachusetts, United States
1182.12.61 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts, United States
United States, Michigan
1182.12.13 University of Michigan Health System
Ann Arbor, Michigan, United States
1182.12.54 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
1182.12.56 Boehringer Ingelheim Investigational Site
Detroit, Michigan, United States
United States, Minnesota
1182.12.120 Department of Medicine, HIV/AIDS Program
Minneapolis, Minnesota, United States
United States, Missouri
1182.12.14 Dybedal Center for Clinical Research
Kansas City, Missouri, United States
1182.12.87 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
United States, Nevada
1182.12.11 Wellness Center
Las Vegas, Nevada, United States
United States, New Jersey
1182.12.4 Boehringer Ingelheim Investigational Site
Camden, New Jersey, United States
1182.12.21 Boehringer Ingelheim Investigational Site
East Orange, New Jersey, United States
United States, New Mexico
1182.12.40 Boehringer Ingelheim Investigational Site
Santa Fe, New Mexico, United States
United States, New York
1182.12.68 Boehringer Ingelheim Investigational Site
Albany, New York, United States
1182.12.34 Boehringer Ingelheim Investigational Site
Mount Vernon, New York, United States
1182.12.58 Beth Israel Medical Center
New York, New York, United States
1182.12.22 Boehringer Ingelheim Investigational Site
New York, New York, United States
1182.12.96 Boehringer Ingelheim Investigational Site
New York, New York, United States
1182.12.36 Boehringer Ingelheim Investigational Site
New York, New York, United States
1182.12.119 Boehringer Ingelheim Investigational Site
New York, New York, United States
1182.12.107 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
1182.12.83 Boehringer Ingelheim Investigational Site
Stony Brook, New York, United States
1182.12.43 Boehringer Ingelheim Investigational Site
Valhalla, New York, United States
United States, North Carolina
1182.12.42 Boehringer Ingelheim Investigational Site
Durham, North Carolina, United States
1182.12.46 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina, United States
United States, Ohio
1182.12.109 Boehringer Ingelheim Investigational Site
Akron, Ohio, United States
1182.12.24 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1182.12.35 Boehringer Ingelheim Investigational Site
Cleveland, Ohio, United States
1182.12.65 Ohio State University Medical Center
Columbus, Ohio, United States
United States, Oklahoma
1182.12.80 Infectious Disease Institute Clinical Trials Unit
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
1182.12.114 Pinnacle Health
Harrisburg, Pennsylvania, United States
1182.12.50 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1182.12.28 University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Rhode Island
1182.12.86 The Miriam Hospital
Providence, Rhode Island, United States
United States, South Carolina
1182.12.10 Boehringer Ingelheim Investigational Site
Columbia, South Carolina, United States
1182.12.116 Greenville Hospital System
Greenville, South Carolina, United States
United States, Tennessee
1182.12.2 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
United States, Texas
1182.12.55 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1182.12.106 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1182.12.31 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1182.12.73 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1182.12.26 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Virginia
1182.12.91 Boehringer Ingelheim Investigational Site
Annandale, Virginia, United States
1182.12.122 VCU Health Systems
Richmond, Virginia, United States
United States, Washington
1182.12.15 Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
United States, Wisconsin
1182.12.29 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
Australia, New South Wales
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
1182.12.1408 407 Doctors Pty Ltd.
Darlinghurst, New South Wales, Australia
1182.12.1407 Holdsworth House General Practice
Darlinghurst, New South Wales, Australia
1182.12.1403 Albion Street Centre
Surry Hills, New South Wales, Australia
Australia, Queensland
1182.12.1406 Gold Coast Sexual Health Clinic
Miami, Queensland, Australia
Australia, Victoria
1182.12.1404 Alfred Hospital
Melbourne, Victoria, Australia
Canada, British Columbia
1182.12.11002 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, Manitoba
1182.12.11010 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
1182.12.11016 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Canada, Ontario
1182.12.11012 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1182.12.11001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1182.12.11004 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1182.12.11009 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1182.12.11006 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1182.12.11014 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1182.12.11015 Boehringer Ingelheim Investigational Site
Monteal, 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
Montreal, Quebec, Canada
Puerto Rico
1182.12.60 Boehringer Ingelheim Investigational Site
Santurce, Puerto Rico
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00054717     History of Changes
Other Study ID Numbers: 1182.12
Study First Received: February 7, 2003
Results First Received: September 9, 2009
Last Updated: June 23, 2014
Health Authority: Australia: Responsilble Ethics Committee
Canada: Health Canada (TPD)
United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
HIV Protease Inhibitors
Tipranavir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014