Clinical trial NCT00054717: Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)
Official title: Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low-dose Ritonavir (TPV/RTV) Verses Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2003-02-10
Enrollment: 630
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Treatment Response at Week 48
timeFrame: At week 48
measure: Time to Treatment Failure Through 48 Weeks of Treatment
timeFrame: Week 48
Secondary outcomes:
measure: Treatment Response at Week 24
timeFrame: Week 24
measure: Treatment Response at Week 2
timeFrame: week 2
measure: Treatment Response at Week 4
timeFrame: week 4
measure: Treatment Response at Week 8
timeFrame: week 8
measure: Treatment Response at Week 16
timeFrame: week 16
measure: Treatment Response at Week 32
timeFrame: Week 32
measure: Treatment Response at Week 40
timeFrame: Week 40
measure: Treatment Response at Week 48
timeFrame: Week 48
measure: Treatment Response at Week 56
timeFrame: week 56
measure: Treatment Response at Week 64
timeFrame: week 64
measure: Treatment Response at Week 72
timeFrame: Week 72
measure: Treatment Response at Week 80
timeFrame: Week 80
measure: Treatment Response at Week 88
timeFrame: Week 88
measure: Treatment Response at Week 96
timeFrame: Week 96
measure: Time to Treatment Failure Through 96 Weeks of Treatment
timeFrame: Week 96
measure: Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
timeFrame: Week 48
measure: Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
timeFrame: Week 96
measure: Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF
timeFrame: Week 2 through Week 96 (at any point during trial)
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 2
timeFrame: Week 2
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 4
timeFrame: Week 4
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 8
timeFrame: Week 8
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 16
timeFrame: Week 16
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 24
timeFrame: Week 24
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 32
timeFrame: Week 32
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 40
timeFrame: Week 40
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 48
timeFrame: Week 48
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 56
timeFrame: Week 56
measure: Virologic Response (Viral Load >= 1 Log Drop) at Week 64
timeFrame: Week 64
measure: Median Change From Baseline in Viral Load to Week 2
timeFrame: Baseline to Week 2
measure: Median Change From Baseline in Viral Load to Week 4
timeFrame: Baseline to Week 4
measure: Median Change From Baseline in Viral Load to Week 8
timeFrame: Baseline to Week 8
measure: Median Change From Baseline in Viral Load to Week 16
timeFrame: Baseline to Week 16
measure: Median Change From Baseline in Viral Load to Week 24
timeFrame: Baseline to Week 24
measure: Median Change From Baseline in Viral Load to Week 32
timeFrame: Baseline to Week 32
measure: Median Change From Baseline in Viral Load to Week 40
timeFrame: Baseline to Week 40
measure: Median Change From Baseline in Viral Load to Week 48
timeFrame: Baseline to Week 48
measure: Median Change From Baseline in Viral Load to Week 56
timeFrame: Baseline to Week 56
measure: Median Change From Baseline in Viral Load to Week 64
timeFrame: Baseline to Week 64
measure: Median Change From Baseline in Viral Load to Week 72
timeFrame: Baseline to Week 72
measure: Median Change From Baseline in Viral Load to Week 80
timeFrame: Baseline to Week 80
measure: Median Change From Baseline in Viral Load to Week 88
timeFrame: Baseline to Week 88
measure: Median Change From Baseline in Viral Load to Week 96
timeFrame: Baseline to Week 96
measure: Mean Change From Baseline to Week 2 in CD4+ Cell Count
timeFrame: Baseline to Week 2
measure: Mean Change From Baseline to Week 4 in CD4+ Cell Count
timeFrame: Baseline to Week 4
measure: Mean Change From Baseline to Week 8 in CD4+ Cell Count
timeFrame: Baseline to Week 8
measure: Mean Change From Baseline to Week 16 in CD4+ Cell Count
timeFrame: Baseline to Week 16
measure: Mean Change From Baseline to Week 24 in CD4+ Cell Count
timeFrame: Baseline to Week 24
measure: Mean Change From Baseline to Week 32 in CD4+ Cell Count
timeFrame: Baseline to Week 32
measure: Mean Change From Baseline to Week 40 in CD4+ Cell Count
timeFrame: Baseline to Week 40
measure: Mean Change From Baseline to Week 48 in CD4+ Cell Count
timeFrame: Baseline to Week 48
measure: Mean Change From Baseline to Week 56 in CD4+ Cell Count
timeFrame: Baseline to Week 56
measure: Mean Change From Baseline to Week 64 in CD4+ Cell Count
timeFrame: Baseline to Week 64
measure: Mean Change From Baseline to Week 72 in CD4+ Cell Count
timeFrame: Baseline to Week 72
measure: Mean Change From Baseline to Week 80 in CD4+ Cell Count
timeFrame: Baseline to Week 80
measure: Mean Change From Baseline to Week 88 in CD4+ Cell Count
timeFrame: Baseline to Week 88
measure: Mean Change From Baseline to Week 96 in CD4+ Cell Count
timeFrame: Baseline to Week 96
measure: Time to New CDC Class C Progression Event or Death.
timeFrame: after 48 weeks of treatment
measure: Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF
timeFrame: Week 2 through Week 96 (at any point during trial)
measure: Virologic Response (VL < 400 Copies/ml) at Week 2
timeFrame: Week 2
measure: Virologic Response (VL < 400 Copies/ml) at Week 4
timeFrame: Week 4
measure: Virologic Response (VL < 400 Copies/ml) at Week 8
timeFrame: Week 8
measure: Virologic Response (VL < 400 Copies/ml) at Week 16
timeFrame: Week 16
measure: Virologic Response (VL < 400 Copies/ml) at Week 24
timeFrame: Week 24
measure: Virologic Response (VL < 400 Copies/ml) at Week 32
timeFrame: week 32
measure: Virologic Response (VL < 400 Copies/ml) at Week 40
timeFrame: Week 40
measure: Virologic Response (VL < 400 Copies/ml) at Week 48
timeFrame: Week 48
measure: Virologic Response (VL < 400 Copies/ml) at Week 56
timeFrame: Week 56
measure: Virologic Response (VL < 400 Copies/ml) at Week 64
timeFrame: Week 64
measure: Virologic Response (VL < 400 Copies/ml) at Week 72
timeFrame: Week 72
measure: Virologic Response (VL < 400 Copies/ml) at Week 80
timeFrame: Week 80
measure: Virologic Response (VL < 400 Copies/ml) at Week 88
timeFrame: week 88
measure: Virologic Response (VL < 400 Copies/ml) at Week 96
timeFrame: week 96
measure: Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF
timeFrame: Week 2 through Week 96 (at any point during trial)
measure: Virologic Response (VL < 50 Copies/ml) at Week 2
timeFrame: Week 2
measure: Virologic Response (VL < 50 Copies/ml) at Week 4
timeFrame: Week 4
measure: Virologic Response (VL < 50 Copies/ml) at Week 8
timeFrame: Week 8
measure: Virologic Response (VL < 50 Copies/ml) at Week 16
timeFrame: Week 16
measure: Virologic Response (VL < 50 Copies/ml) at Week 24
timeFrame: Week 24
measure: Virologic Response (VL < 50 Copies/ml) at Week 32
timeFrame: Week 32
measure: Virologic Response (VL < 50 Copies/ml) at Week 40
timeFrame: Week 40
measure: Virologic Response (VL < 50 Copies/ml) at Week 48
timeFrame: Week 48
measure: Virologic Response (VL < 50 Copies/ml) at Week 56
timeFrame: Week 56
measure: Virologic Response (VL < 50 Copies/ml) at Week 64
timeFrame: Week 64
measure: Virologic Response (VL < 50 Copies/ml) at Week 72
timeFrame: Week 72
measure: Virologic Response (VL < 50 Copies/ml) at Week 80
timeFrame: Week 80
measure: Virologic Response (VL < 50 Copies/ml) at Week 88
timeFrame: Week 88
measure: Virologic Response (VL < 50 Copies/ml) at Week 96
timeFrame: Week 96
measure: Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities
timeFrame: 240 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 1182.12.62 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tucson
country: United States
facility: 1182.12.108 El Rio SIA
state: Arizona
city: Berkeley
country: United States
facility: 1182.12.9 Boehringer Ingelheim Investigational Site
state: California
city: Beverly Hills
country: United States
facility: 1182.12.23 Boehringer Ingelheim Investigational Site
state: California
city: Fountain Valley
country: United States
facility: 1182.12.12 Boehringer Ingelheim Investigational Site
state: California
city: Long Beach
country: United States
facility: 1182.12.76 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1182.12.1 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1182.12.59 David Geffen School of Medicine at UCLA
state: California
city: Los Angeles
country: United States
facility: 1182.12.82 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1182.12.97 Boehringer Ingelheim Investigational Site
state: California
city: Sacramento
country: United States
facility: 1182.12.69 UC Davis Medical Center
state: California
city: San Diego
country: United States
facility: 1182.12.89 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1182.12.99 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 1182.12.25 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 1182.12.5 Boehringer Ingelheim Investigational Site
state: California
city: San Francisco
country: United States
facility: 1182.12.53 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 1182.12.98 University of Colorado Health Sciences Center
state: Colorado
city: Norwalk
country: United States
facility: 1182.12.7 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Washington
country: United States
facility: 1182.12.103 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: 1182.12.52 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: 1182.12.70
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: 1182.12.79 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: 1182.12.77 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: 1182.12.93 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1182.12.45 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 1182.12.75 CARES Resource
state: Florida
city: Miami
country: United States
facility: 1182.12.85 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 1182.12.17 Boehringer Ingelheim Investigational Site
state: Florida
city: Sarasota
country: United States
facility: 1182.12.90 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1182.12.63 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1182.12.78 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1182.12.94 Infectious Disease Research Institute
state: Florida
city: Vero Beach
country: United States
facility: 1182.12.67 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1182.12.123 Infectious Disease Clinics of Emory
state: Georgia
city: Atlanta
country: United States
facility: 1182.12.88 Boehringer Ingelheim Investigational Site
state: Georgia
city: Decatur
country: United States
facility: 1182.12.72 Boehringer Ingelheim Investigational Site
state: Georgia
city: Macon
country: United States
facility: 1182.12.47 Boehringer Ingelheim Investigational Site
state: Georgia
city: Boise
country: United States
facility: 1182.12.8 Family Practice Medical Center
state: Idaho
city: Chicago
country: United States
facility: 1182.12.105 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 1182.12.3 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 1182.12.49 Boehringer Ingelheim Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: 1182.12.32 Boehringer Ingelheim Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: 1182.12.48 Boehringer Ingelheim Investigational Site
state: Indiana
city: Lexington
country: United States
facility: 1182.12.33 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: 1182.12.44 Boehringer Ingelheim Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: 1182.12.95 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Portland
country: United States
facility: 1182.12.81 Boehringer Ingelheim Investigational Site
state: Maine
city: Baltimore
country: United States
facility: 1182.12.30 Boehringer Ingelheim Investigational Site
state: Maryland
city: Bethesda
country: United States
facility: 1182.12.6 Boehringer Ingelheim Investigational Site
state: Maryland
city: Boston
country: United States
facility: 1182.12.100 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: 1182.12.101 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: 1182.12.41 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: 1182.12.61 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: 1182.12.13 University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: 1182.12.54 Boehringer Ingelheim Investigational Site
state: Michigan
city: Detroit
country: United States
facility: 1182.12.56 Boehringer Ingelheim Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: 1182.12.120 Department of Medicine, HIV/AIDS Program
state: Minnesota
city: Kansas City
country: United States
facility: 1182.12.14 Dybedal Center for Clinical Research
state: Missouri
city: St Louis
country: United States
facility: 1182.12.87 Boehringer Ingelheim Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: 1182.12.11 Wellness Center
state: Nevada
city: Camden
country: United States
facility: 1182.12.4 Boehringer Ingelheim Investigational Site
state: New Jersey
city: East Orange
country: United States
facility: 1182.12.21 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Santa Fe
country: United States
facility: 1182.12.40 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Albany
country: United States
facility: 1182.12.68 Boehringer Ingelheim Investigational Site
state: New York
city: Mount Vernon
country: United States
facility: 1182.12.34 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1182.12.119 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1182.12.22 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1182.12.36 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1182.12.58 Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: 1182.12.96 Boehringer Ingelheim Investigational Site
state: New York
city: Rochester
country: United States
facility: 1182.12.107 Boehringer Ingelheim Investigational Site
state: New York
city: Stony Brook
country: United States
facility: 1182.12.83 Boehringer Ingelheim Investigational Site
state: New York
city: Valhalla
country: United States
facility: 1182.12.43 Boehringer Ingelheim Investigational Site
state: New York
city: Durham
country: United States
facility: 1182.12.42 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: 1182.12.46 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Akron
country: United States
facility: 1182.12.109 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 1182.12.24 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 1182.12.35 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 1182.12.65 Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: 1182.12.80 Infectious Disease Institute Clinical Trials Unit
state: Oklahoma
city: Harrisburg
country: United States
facility: 1182.12.114 Pinnacle Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: 1182.12.28 University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: 1182.12.50 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: 1182.12.86 The Miriam Hospital
state: Rhode Island
city: Columbia
country: United States
facility: 1182.12.10 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1182.12.116 Greenville Hospital System
state: South Carolina
city: Memphis
country: United States
facility: 1182.12.2 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: 1182.12.106 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1182.12.55 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1182.12.31 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1182.12.73 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1182.12.26 Boehringer Ingelheim Investigational Site
state: Texas
city: Annandale
country: United States
facility: 1182.12.91 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 1182.12.122 VCU Health Systems
state: Virginia
city: Seattle
country: United States
facility: 1182.12.15 Boehringer Ingelheim Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: 1182.12.29 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Darlinghurst
country: Australia
facility: 1182.12.1401 St. Vincent's Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: 1182.12.1405 AIDS Research Initiative / Ground Zero
state: New South Wales
city: Darlinghurst
country: Australia
facility: 1182.12.1407 Holdsworth House General Practice
state: New South Wales
city: Darlinghurst
country: Australia
facility: 1182.12.1408 407 Doctors Pty Ltd.
state: New South Wales
city: Surry Hills
country: Australia
facility: 1182.12.1403 Albion Street Centre
state: New South Wales
city: Miami
country: Australia
facility: 1182.12.1406 Gold Coast Sexual Health Clinic
state: Queensland
city: Melbourne
country: Australia
facility: 1182.12.1404 Alfred Hospital
state: Victoria
city: Vancouver
country: Canada
facility: 1182.12.11002 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 1182.12.11010 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: 1182.12.11016 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: 1182.12.11012 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1182.12.11001 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1182.12.11004 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1182.12.11006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1182.12.11009 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1182.12.11014 Boehringer Ingelheim Investigational Site
state: Ontario
city: Monteal
country: Canada
facility: 1182.12.11015 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1182.12.11003 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1182.12.11007 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1182.12.11013 Boehringer Ingelheim Investigational Site
state: Quebec
city: Santurce
country: Puerto Rico
facility: 1182.12.60 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Hicks CB, Cahn P, Cooper DA, Walmsley SL, Katlama C, Clotet B, Lazzarin A, Johnson MA, Neubacher D, Mayers D, Valdez H; RESIST investigator group. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet. 2006 Aug 5;368(9534):466-75. doi: 10.1016/S0140-6736(06)69154-X.