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

NCT ID: NCT00054717

Last Updated: 2014-07-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

630 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Tipranavir(TPV)/low dose ritonavir(r)

Group Type OTHER

Tipranavir

Intervention Type DRUG

Ritonavir(r)

Intervention Type DRUG

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

Group Type OTHER

Ritonavir(r)

Intervention Type DRUG

Comparator Protease Inhibitor (CPI)

Intervention Type DRUG

Interventions

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Tipranavir

Intervention Type DRUG

Ritonavir(r)

Intervention Type DRUG

Comparator Protease Inhibitor (CPI)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1182.12.62 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

1182.12.108 El Rio SIA

Tucson, Arizona, United States

Site Status

1182.12.9 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Site Status

1182.12.23 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Site Status

1182.12.12 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Site Status

1182.12.76 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Site Status

1182.12.1 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1182.12.59 David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Site Status

1182.12.82 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1182.12.97 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1182.12.69 UC Davis Medical Center

Sacramento, California, United States

Site Status

1182.12.89 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1182.12.99 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

1182.12.25 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1182.12.5 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1182.12.53 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Site Status

1182.12.98 University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

1182.12.7 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Site Status

1182.12.103 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

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1182.12.52 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Site Status

1182.12.70

Washington D.C., District of Columbia, United States

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1182.12.79 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Site Status

1182.12.77 Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

Site Status

1182.12.45 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1182.12.75 CARES Resource

Miami, Florida, United States

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1182.12.85 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

1182.12.93 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

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1182.12.17 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

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1182.12.90 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

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1182.12.63 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1182.12.78 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1182.12.94 Infectious Disease Research Institute

Tampa, Florida, United States

Site Status

1182.12.67 Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Site Status

1182.12.123 Infectious Disease Clinics of Emory

Atlanta, Georgia, United States

Site Status

1182.12.88 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

1182.12.72 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

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1182.12.47 Boehringer Ingelheim Investigational Site

Macon, Georgia, United States

Site Status

1182.12.8 Family Practice Medical Center

Boise, Idaho, United States

Site Status

1182.12.105 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1182.12.3 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1182.12.49 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

1182.12.32 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

1182.12.48 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

1182.12.33 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

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1182.12.44 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Site Status

1182.12.95 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1182.12.81 Boehringer Ingelheim Investigational Site

Portland, Maine, United States

Site Status

1182.12.30 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

1182.12.6 Boehringer Ingelheim Investigational Site

Bethesda, Maryland, United States

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1182.12.100 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

1182.12.101 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

1182.12.41 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

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1182.12.61 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Site Status

1182.12.13 University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

1182.12.54 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Site Status

1182.12.56 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Site Status

1182.12.120 Department of Medicine, HIV/AIDS Program

Minneapolis, Minnesota, United States

Site Status

1182.12.14 Dybedal Center for Clinical Research

Kansas City, Missouri, United States

Site Status

1182.12.87 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1182.12.11 Wellness Center

Las Vegas, Nevada, United States

Site Status

1182.12.4 Boehringer Ingelheim Investigational Site

Camden, New Jersey, United States

Site Status

1182.12.21 Boehringer Ingelheim Investigational Site

East Orange, New Jersey, United States

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1182.12.40 Boehringer Ingelheim Investigational Site

Santa Fe, New Mexico, United States

Site Status

1182.12.68 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Site Status

1182.12.34 Boehringer Ingelheim Investigational Site

Mount Vernon, New York, United States

Site Status

1182.12.119 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1182.12.22 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1182.12.36 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1182.12.58 Beth Israel Medical Center

New York, New York, United States

Site Status

1182.12.96 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1182.12.107 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

1182.12.83 Boehringer Ingelheim Investigational Site

Stony Brook, New York, United States

Site Status

1182.12.43 Boehringer Ingelheim Investigational Site

Valhalla, New York, United States

Site Status

1182.12.42 Boehringer Ingelheim Investigational Site

Durham, North Carolina, United States

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1182.12.46 Boehringer Ingelheim Investigational Site

Huntersville, North Carolina, United States

Site Status

1182.12.109 Boehringer Ingelheim Investigational Site

Akron, Ohio, United States

Site Status

1182.12.24 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1182.12.35 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Site Status

1182.12.65 Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

1182.12.80 Infectious Disease Institute Clinical Trials Unit

Oklahoma City, Oklahoma, United States

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1182.12.114 Pinnacle Health

Harrisburg, Pennsylvania, United States

Site Status

1182.12.28 University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

1182.12.50 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1182.12.86 The Miriam Hospital

Providence, Rhode Island, United States

Site Status

1182.12.10 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

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1182.12.116 Greenville Hospital System

Greenville, South Carolina, United States

Site Status

1182.12.2 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

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1182.12.106 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1182.12.55 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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1182.12.31 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1182.12.73 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1182.12.26 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1182.12.91 Boehringer Ingelheim Investigational Site

Annandale, Virginia, United States

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1182.12.122 VCU Health Systems

Richmond, Virginia, United States

Site Status

1182.12.15 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

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1182.12.29 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Site Status

1182.12.1401 St. Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

1182.12.1405 AIDS Research Initiative / Ground Zero

Darlinghurst, New South Wales, Australia

Site Status

1182.12.1407 Holdsworth House General Practice

Darlinghurst, New South Wales, Australia

Site Status

1182.12.1408 407 Doctors Pty Ltd.

Darlinghurst, New South Wales, Australia

Site Status

1182.12.1403 Albion Street Centre

Surry Hills, New South Wales, Australia

Site Status

1182.12.1406 Gold Coast Sexual Health Clinic

Miami, Queensland, Australia

Site Status

1182.12.1404 Alfred Hospital

Melbourne, Victoria, Australia

Site Status

1182.12.11002 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1182.12.11010 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Site Status

1182.12.11016 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Site Status

1182.12.11012 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1182.12.11001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1182.12.11004 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1182.12.11006 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1182.12.11009 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1182.12.11014 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1182.12.11015 Boehringer Ingelheim Investigational Site

Monteal, Quebec, Canada

Site Status

1182.12.11003 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1182.12.11007 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1182.12.11013 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1182.12.60 Boehringer Ingelheim Investigational Site

Santurce, , Puerto Rico

Site Status

Countries

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United States Australia Canada Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 16890833 (View on PubMed)

Other Identifiers

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1182.12

Identifier Type: -

Identifier Source: org_study_id

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