HIV InfectionsPhase 3NCT00054717

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

A Phase 3 study testing Tipranavir, Ritonavir(r) and Comparator Protease Inhibitor (CPI) in people with HIV Infections, run by Boehringer Ingelheim at 117 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Tipranavir, Ritonavir(r) and Comparator Protease Inhibitor (CPI)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 630 participants
Where: 117 sitesin 4 countries
Study dates: Jan 2003to Sep 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

117 sites in 4 countries.

Country

City, postcode or hospital

117 sites in 4 countries

United States96 sites

1182.12.109 Boehringer Ingelheim Investigational Site
Akron, Ohio
1182.12.68 Boehringer Ingelheim Investigational Site
Albany, New York
1182.12.13 University of Michigan Health System
Ann Arbor, Michigan
1182.12.91 Boehringer Ingelheim Investigational Site
Annandale, Virginia
1182.12.123 Infectious Disease Clinics of Emory
Atlanta, Georgia
1182.12.88 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1182.12.30 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1182.12.9 Boehringer Ingelheim Investigational Site
Berkeley, California
1182.12.6 Boehringer Ingelheim Investigational Site
Bethesda, Maryland
1182.12.23 Boehringer Ingelheim Investigational Site
Beverly Hills, California
1182.12.8 Family Practice Medical Center
Boise, Idaho
1182.12.100 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1182.12.101 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1182.12.41 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1182.12.4 Boehringer Ingelheim Investigational Site
Camden, New Jersey
1182.12.105 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1182.12.3 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1182.12.49 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1182.12.24 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1182.12.35 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
1182.12.10 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
1182.12.65 Ohio State University Medical Center
Columbus, Ohio
1182.12.106 Boehringer Ingelheim Investigational Site
Dallas, Texas
1182.12.55 Boehringer Ingelheim Investigational Site
Dallas, Texas
1182.12.72 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1182.12.98 University of Colorado Health Sciences Center
Denver, Colorado
1182.12.54 Boehringer Ingelheim Investigational Site
Detroit, Michigan
1182.12.56 Boehringer Ingelheim Investigational Site
Detroit, Michigan
1182.12.42 Boehringer Ingelheim Investigational Site
Durham, North Carolina
1182.12.21 Boehringer Ingelheim Investigational Site
East Orange, New Jersey
1182.12.79 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1182.12.77 Boehringer Ingelheim Investigational Site
Fort Myers, Florida
1182.12.12 Boehringer Ingelheim Investigational Site
Fountain Valley, California
1182.12.116 Greenville Hospital System
Greenville, South Carolina
1182.12.114 Pinnacle Health
Harrisburg, Pennsylvania
1182.12.31 Boehringer Ingelheim Investigational Site
Houston, Texas
1182.12.73 Boehringer Ingelheim Investigational Site
Houston, Texas
1182.12.46 Boehringer Ingelheim Investigational Site
Huntersville, North Carolina
1182.12.32 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
1182.12.48 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
1182.12.14 Dybedal Center for Clinical Research
Kansas City, Missouri
1182.12.11 Wellness Center
Las Vegas, Nevada
1182.12.33 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
1182.12.76 Boehringer Ingelheim Investigational Site
Long Beach, California
1182.12.1 Boehringer Ingelheim Investigational Site
Los Angeles, California
1182.12.59 David Geffen School of Medicine at UCLA
Los Angeles, California
1182.12.82 Boehringer Ingelheim Investigational Site
Los Angeles, California
1182.12.97 Boehringer Ingelheim Investigational Site
Los Angeles, California
1182.12.44 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
1182.12.47 Boehringer Ingelheim Investigational Site
Macon, Georgia
1182.12.2 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1182.12.45 Boehringer Ingelheim Investigational Site
Miami, Florida
1182.12.75 CARES Resource
Miami, Florida
1182.12.85 Boehringer Ingelheim Investigational Site
Miami, Florida
1182.12.93 Boehringer Ingelheim Investigational Site
Miami Beach, Florida
1182.12.29 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
1182.12.120 Department of Medicine, HIV/AIDS Program
Minneapolis, Minnesota
1182.12.34 Boehringer Ingelheim Investigational Site
Mount Vernon, New York
1182.12.95 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1182.12.119 Boehringer Ingelheim Investigational Site
New York, New York
1182.12.22 Boehringer Ingelheim Investigational Site
New York, New York
1182.12.36 Boehringer Ingelheim Investigational Site
New York, New York
1182.12.58 Beth Israel Medical Center
New York, New York
1182.12.96 Boehringer Ingelheim Investigational Site
New York, New York
1182.12.7 Boehringer Ingelheim Investigational Site
Norwalk, Connecticut
1182.12.80 Infectious Disease Institute Clinical Trials Unit
Oklahoma City, Oklahoma
1182.12.17 Boehringer Ingelheim Investigational Site
Orlando, Florida
1182.12.28 University of Pennsylvania
Philadelphia, Pennsylvania
1182.12.50 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1182.12.62 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1182.12.81 Boehringer Ingelheim Investigational Site
Portland, Maine
1182.12.86 The Miriam Hospital
Providence, Rhode Island
1182.12.122 VCU Health Systems
Richmond, Virginia
1182.12.107 Boehringer Ingelheim Investigational Site
Rochester, New York
1182.12.69 UC Davis Medical Center
Sacramento, California
1182.12.26 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1182.12.89 Boehringer Ingelheim Investigational Site
San Diego, California
1182.12.99 Boehringer Ingelheim Investigational Site
San Diego, California
1182.12.25 Boehringer Ingelheim Investigational Site
San Francisco, California
1182.12.5 Boehringer Ingelheim Investigational Site
San Francisco, California
1182.12.53 Boehringer Ingelheim Investigational Site
San Francisco, California
1182.12.40 Boehringer Ingelheim Investigational Site
Santa Fe, New Mexico
1182.12.90 Boehringer Ingelheim Investigational Site
Sarasota, Florida
1182.12.15 Boehringer Ingelheim Investigational Site
Seattle, Washington
1182.12.61 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
1182.12.87 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1182.12.83 Boehringer Ingelheim Investigational Site
Stony Brook, New York
1182.12.63 Boehringer Ingelheim Investigational Site
Tampa, Florida
1182.12.78 Boehringer Ingelheim Investigational Site
Tampa, Florida
1182.12.94 Infectious Disease Research Institute
Tampa, Florida
1182.12.108 El Rio SIA
Tucson, Arizona
1182.12.43 Boehringer Ingelheim Investigational Site
Valhalla, New York
1182.12.67 Boehringer Ingelheim Investigational Site
Vero Beach, Florida
1182.12.103 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1182.12.52 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia
1182.12.70
Washington D.C., District of Columbia

Other trials in United States

Canada13 sites

1182.12.11016 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
1182.12.11012 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1182.12.11015 Boehringer Ingelheim Investigational Site
Monteal, Quebec
1182.12.11003 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1182.12.11007 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1182.12.11013 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1182.12.11001 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1182.12.11004 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1182.12.11006 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1182.12.11009 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1182.12.11014 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1182.12.11002 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
1182.12.11010 Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba

Other trials in Canada

Australia7 sites

1182.12.1401 St. Vincent's Hospital
Darlinghurst, New South Wales
1182.12.1405 AIDS Research Initiative / Ground Zero
Darlinghurst, New South Wales
1182.12.1407 Holdsworth House General Practice
Darlinghurst, New South Wales
1182.12.1408 407 Doctors Pty Ltd.
Darlinghurst, New South Wales
1182.12.1404 Alfred Hospital
Melbourne, Victoria
1182.12.1406 Gold Coast Sexual Health Clinic
Miami, Queensland
1182.12.1403 Albion Street Centre
Surry Hills, New South Wales

Other trials in Australia

Puerto Rico1 site

1182.12.60 Boehringer Ingelheim Investigational Site
Santurce

Other trials in Puerto Rico

About this study

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.

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.

Conditions: HIV Infections
Being tested: Tipranavir, Ritonavir(r), Comparator Protease Inhibitor (CPI)
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TipranavirDrug
Ritonavir(r)Drug
Comparator Protease Inhibitor (CPI)Drug

Study groups in NCT00054717
Study group	Role	What they receive
Tipranavir(TPV)/low dose ritonavir(r)	Other	Not described Receives: Drug: Tipranavir; Drug: Ritonavir(r)
Comparator protease inhibitor(CPI)/low dose ritonavir(r)	Other	Not described Receives: Drug: Ritonavir(r); Drug: Comparator Protease Inhibitor (CPI)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: At week 48
Time to Treatment Failure Through 48 Weeks of Treatment
Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
Measured: Week 48

Secondary outcomes (88)

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
Measured: Week 24
Treatment Response at Week 2
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: week 2
Treatment Response at Week 4
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: week 4
Treatment Response at Week 8
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: week 8
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
Measured: week 16
Treatment Response at Week 32
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: Week 32
Treatment Response at Week 40
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: Week 40
Treatment Response at Week 48
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: Week 48
Treatment Response at Week 56
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: week 56
Treatment Response at Week 64
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: week 64
Treatment Response at Week 72
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: Week 72
Treatment Response at Week 80
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: Week 80
Treatment Response at Week 88
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: Week 88
Treatment Response at Week 96
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Measured: Week 96
Time to Treatment Failure Through 96 Weeks of Treatment
time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.
Measured: Week 96
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.
Measured: Week 48
Time to Confirmed Virologic Failure Through 96 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.
Measured: Week 96
Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 2 through Week 96 (at any point during trial)
Virologic Response (Viral Load >= 1 Log Drop) at Week 2
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 2
Virologic Response (Viral Load >= 1 Log Drop) at Week 4
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 4
Virologic Response (Viral Load >= 1 Log Drop) at Week 8
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 8
Virologic Response (Viral Load >= 1 Log Drop) at Week 16
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 16
Virologic Response (Viral Load >= 1 Log Drop) at Week 24
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 24
Virologic Response (Viral Load >= 1 Log Drop) at Week 32
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 32
Virologic Response (Viral Load >= 1 Log Drop) at Week 40
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 40
Virologic Response (Viral Load >= 1 Log Drop) at Week 48
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 48
Virologic Response (Viral Load >= 1 Log Drop) at Week 56
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 56
Virologic Response (Viral Load >= 1 Log Drop) at Week 64
Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline
Measured: Week 64
Median Change From Baseline in Viral Load to Week 2
Measured: Baseline to Week 2
Median Change From Baseline in Viral Load to Week 4
Measured: Baseline to Week 4
Median Change From Baseline in Viral Load to Week 8
Measured: Baseline to Week 8
Median Change From Baseline in Viral Load to Week 16
Measured: Baseline to Week 16
Median Change From Baseline in Viral Load to Week 24
Measured: Baseline to Week 24
Median Change From Baseline in Viral Load to Week 32
Measured: Baseline to Week 32
Median Change From Baseline in Viral Load to Week 40
Measured: Baseline to Week 40
Median Change From Baseline in Viral Load to Week 48
Measured: Baseline to Week 48
Median Change From Baseline in Viral Load to Week 56
Measured: Baseline to Week 56
Median Change From Baseline in Viral Load to Week 64
Measured: Baseline to Week 64
Median Change From Baseline in Viral Load to Week 72
Measured: Baseline to Week 72
Median Change From Baseline in Viral Load to Week 80
Measured: Baseline to Week 80
Median Change From Baseline in Viral Load to Week 88
Measured: Baseline to Week 88
Median Change From Baseline in Viral Load to Week 96
Measured: Baseline to Week 96
Mean Change From Baseline to Week 2 in CD4+ Cell Count
Measured: Baseline to Week 2
Mean Change From Baseline to Week 4 in CD4+ Cell Count
Measured: Baseline to Week 4
Mean Change From Baseline to Week 8 in CD4+ Cell Count
Measured: Baseline to Week 8
Mean Change From Baseline to Week 16 in CD4+ Cell Count
Measured: Baseline to Week 16
Mean Change From Baseline to Week 24 in CD4+ Cell Count
Measured: Baseline to Week 24
Mean Change From Baseline to Week 32 in CD4+ Cell Count
Measured: Baseline to Week 32
Mean Change From Baseline to Week 40 in CD4+ Cell Count
Measured: Baseline to Week 40
Mean Change From Baseline to Week 48 in CD4+ Cell Count
Measured: Baseline to Week 48
Mean Change From Baseline to Week 56 in CD4+ Cell Count
Measured: Baseline to Week 56
Mean Change From Baseline to Week 64 in CD4+ Cell Count
Measured: Baseline to Week 64
Mean Change From Baseline to Week 72 in CD4+ Cell Count
Measured: Baseline to Week 72
Mean Change From Baseline to Week 80 in CD4+ Cell Count
Measured: Baseline to Week 80
Mean Change From Baseline to Week 88 in CD4+ Cell Count
Measured: Baseline to Week 88
Mean Change From Baseline to Week 96 in CD4+ Cell Count
Measured: Baseline to Week 96
Time to New CDC Class C Progression Event or Death.
Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death
Measured: after 48 weeks of treatment
Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 2 through Week 96 (at any point during trial)
Virologic Response (VL < 400 Copies/ml) at Week 2
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 2
Virologic Response (VL < 400 Copies/ml) at Week 4
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 4
Virologic Response (VL < 400 Copies/ml) at Week 8
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 8
Virologic Response (VL < 400 Copies/ml) at Week 16
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 16
Virologic Response (VL < 400 Copies/ml) at Week 24
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 24
Virologic Response (VL < 400 Copies/ml) at Week 32
Percentage of participants with Viral Load < 400 copies/mL
Measured: week 32
Virologic Response (VL < 400 Copies/ml) at Week 40
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 40
Virologic Response (VL < 400 Copies/ml) at Week 48
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 48
Virologic Response (VL < 400 Copies/ml) at Week 56
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 56
Virologic Response (VL < 400 Copies/ml) at Week 64
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 64
Virologic Response (VL < 400 Copies/ml) at Week 72
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 72
Virologic Response (VL < 400 Copies/ml) at Week 80
Percentage of participants with Viral Load < 400 copies/mL
Measured: Week 80
Virologic Response (VL < 400 Copies/ml) at Week 88
Percentage of participants with Viral Load < 400 copies/mL
Measured: week 88
Virologic Response (VL < 400 Copies/ml) at Week 96
Percentage of participants with Viral Load < 400 copies/mL
Measured: week 96
Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 2 through Week 96 (at any point during trial)
Virologic Response (VL < 50 Copies/ml) at Week 2
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 2
Virologic Response (VL < 50 Copies/ml) at Week 4
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 4
Virologic Response (VL < 50 Copies/ml) at Week 8
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 8
Virologic Response (VL < 50 Copies/ml) at Week 16
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 16
Virologic Response (VL < 50 Copies/ml) at Week 24
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 24
Virologic Response (VL < 50 Copies/ml) at Week 32
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 32
Virologic Response (VL < 50 Copies/ml) at Week 40
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 40
Virologic Response (VL < 50 Copies/ml) at Week 48
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 48
Virologic Response (VL < 50 Copies/ml) at Week 56
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 56
Virologic Response (VL < 50 Copies/ml) at Week 64
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 64
Virologic Response (VL < 50 Copies/ml) at Week 72
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 72
Virologic Response (VL < 50 Copies/ml) at Week 80
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 80
Virologic Response (VL < 50 Copies/ml) at Week 88
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 88
Virologic Response (VL < 50 Copies/ml) at Week 96
Percentage of participants with Viral Load < 50 copies/mL
Measured: Week 96
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.
Measured: 240 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Sep 2008

First posted10 Feb 2003 (estimated)
Study startJan 2003
Primary completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Intervention model: Parallel groups
Enrolment: 630 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00054717
Sponsor's protocol ID: 1182.12
Status last verified: Apr 2014
First submitted: 7 Feb 2003
Last updated: 2 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 16890833

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00054717
Acronym / sponsor ID: 1182.12
Conditions: HIV Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 630 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2003
Primary completion: Sep 2008 (actual)
First posted: 10 Feb 2003 (estimated)
Results: Posted 19 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Number of arms: 2

Arm	Type	Receives
Tipranavir(TPV)/low dose ritonavir(r)	Other	Drug: Tipranavir, Drug: Ritonavir(r)
Comparator protease inhibitor(CPI)/low dose ritonavir(r)	Other	Drug: Ritonavir(r), Drug: Comparator Protease Inhibitor (CPI)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tipranavir	Drug	Tipranavir(TPV)/low dose ritonavir(r)
Ritonavir(r)	Drug	Comparator protease inhibitor(CPI)/low dose ritonavir(r), Tipranavir(TPV)/low dose ritonavir(r)
Comparator Protease Inhibitor (CPI)	Drug	Comparator protease inhibitor(CPI)/low dose ritonavir(r)

Primary outcome

Treatment Response at Week 48
Time frame: At week 48
Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound
Time to Treatment Failure Through 48 Weeks of Treatment
Time frame: Week 48
Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.

88 secondary outcomes

Treatment Response at Week 24
Time frame: Week 24
Treatment Response at Week 2
Time frame: week 2
Treatment Response at Week 4
Time frame: week 4
Treatment Response at Week 8
Time frame: week 8
Treatment Response at Week 16
Time frame: week 16
Treatment Response at Week 32
Time frame: Week 32
Treatment Response at Week 40
Time frame: Week 40
Treatment Response at Week 48
Time frame: Week 48
Treatment Response at Week 56
Time frame: week 56
Treatment Response at Week 64
Time frame: week 64
Treatment Response at Week 72
Time frame: Week 72
Treatment Response at Week 80
Time frame: Week 80
Treatment Response at Week 88
Time frame: Week 88
Treatment Response at Week 96
Time frame: Week 96
Time to Treatment Failure Through 96 Weeks of Treatment
Time frame: Week 96
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Time frame: Week 48
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Time frame: Week 96
Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF
Time frame: Week 2 through Week 96 (at any point during trial)
Virologic Response (Viral Load >= 1 Log Drop) at Week 2
Time frame: Week 2
Virologic Response (Viral Load >= 1 Log Drop) at Week 4
Time frame: Week 4
Virologic Response (Viral Load >= 1 Log Drop) at Week 8
Time frame: Week 8
Virologic Response (Viral Load >= 1 Log Drop) at Week 16
Time frame: Week 16
Virologic Response (Viral Load >= 1 Log Drop) at Week 24
Time frame: Week 24
Virologic Response (Viral Load >= 1 Log Drop) at Week 32
Time frame: Week 32
Virologic Response (Viral Load >= 1 Log Drop) at Week 40
Time frame: Week 40
Virologic Response (Viral Load >= 1 Log Drop) at Week 48
Time frame: Week 48
Virologic Response (Viral Load >= 1 Log Drop) at Week 56
Time frame: Week 56
Virologic Response (Viral Load >= 1 Log Drop) at Week 64
Time frame: Week 64
Median Change From Baseline in Viral Load to Week 2
Time frame: Baseline to Week 2
Median Change From Baseline in Viral Load to Week 4
Time frame: Baseline to Week 4
Median Change From Baseline in Viral Load to Week 8
Time frame: Baseline to Week 8
Median Change From Baseline in Viral Load to Week 16
Time frame: Baseline to Week 16
Median Change From Baseline in Viral Load to Week 24
Time frame: Baseline to Week 24
Median Change From Baseline in Viral Load to Week 32
Time frame: Baseline to Week 32
Median Change From Baseline in Viral Load to Week 40
Time frame: Baseline to Week 40
Median Change From Baseline in Viral Load to Week 48
Time frame: Baseline to Week 48
Median Change From Baseline in Viral Load to Week 56
Time frame: Baseline to Week 56
Median Change From Baseline in Viral Load to Week 64
Time frame: Baseline to Week 64
Median Change From Baseline in Viral Load to Week 72
Time frame: Baseline to Week 72
Median Change From Baseline in Viral Load to Week 80
Time frame: Baseline to Week 80

Results and safety

Results posted to the registry on 19 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tipranavir(TPV)/Low Dose Ritonavir(r)	313	51
Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)	317	18

Primary outcome: Treatment Response at Week 48

Time frame: At week 48. Number. Unit: percentage of participants

Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n = 311	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n = 309
Value	33.80	16.20

Tipranavir(TPV)/Low Dose Ritonavir(r) vs Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r): p = 0.0001, Cochran-Mantel-Haenszel

Population analysed: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

Primary outcome: Time to Treatment Failure Through 48 Weeks of Treatment

Time frame: Week 48. Median (Inter-Quartile Range). Unit: Days

Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n = 313	Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r) n = 317
Value	113 (0 to 395)	0 (0 to 171)

Tipranavir(TPV)/Low Dose Ritonavir(r) vs Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r): p = 0.0001, Log Rank

Population analysed: FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication

89 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 240 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tipranavir(TPV)/Low Dose Ritonavir(r)	113 of 311 (36.3%)	301 of 311 (96.8%)	Not reported
Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)	61 of 309 (19.7%)	271 of 309 (87.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 16890833Hicks 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.
Related InfoLink provided by the sponsor.

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Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

117 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tipranavir, Ritonavir(r) and Comparator Protease Inhibitor (CPI) in people with HIV Infections, run by Boehringer Ingelheim at 117 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Canada, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Response at Week 48 (time frame: At week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054717, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.