NCT00054717|CompletedPhase 3Results

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

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.

Boehringer Ingelheim ClinicalTrials.gov

Compare

1 other identifier

1182.12

Study Type

interventional

Target

630

Locations

4 countries

Sites

117

Timeline

RegisteredFeb 2003

StartedJan 2003

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

630

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Geographic Reach

4 countries

117 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2003

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2003

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 19, 2009

Completed

Last Updated

July 2, 2014

Status Verified

April 1, 2014

Enrollment Period

5.7 years

First QC Date

February 7, 2003

Results QC Date

September 9, 2009

Last Update Submit

June 23, 2014

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

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
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.
Week 48

Secondary Outcomes (88)

Treatment Response at Week 24
Week 24
Treatment Response at Week 2
week 2
Treatment Response at Week 4
week 4
Treatment Response at Week 8
week 8
Treatment Response at Week 16
week 16
+83 more secondary outcomes

Study Arms (2)

Tipranavir(TPV)/low dose ritonavir(r)

OTHER

Drug: TipranavirDrug: Ritonavir(r)

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

OTHER

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

Interventions

TipranavirDRUG

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)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:
N, 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.
\. 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.
\. Human Immunodeficiency Virus 1 (HIV-1) viral load \>=1,000 copies/mL at screening.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boehringer Ingelheimlead

Study Sites (117)

1182.12.62 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1182.12.108 El Rio SIA

Tucson, Arizona, United States

Location

1182.12.9 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

1182.12.23 Boehringer Ingelheim Investigational Site

Beverly Hills, California, United States

Location

1182.12.12 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

1182.12.76 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1182.12.1 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1182.12.59 David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Location

1182.12.82 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1182.12.97 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1182.12.69 UC Davis Medical Center

Sacramento, California, United States

Location

1182.12.89 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1182.12.99 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

1182.12.25 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1182.12.5 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1182.12.53 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

1182.12.98 University of Colorado Health Sciences Center

Denver, Colorado, United States

Location

1182.12.7 Boehringer Ingelheim Investigational Site

Norwalk, Connecticut, United States

Location

1182.12.103 Boehringer Ingelheim Investigational Site

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

Location

1182.12.52 Boehringer Ingelheim Investigational Site

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

Location

1182.12.70

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

Location

1182.12.79 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1182.12.77 Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

Location

1182.12.45 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1182.12.75 CARES Resource

Miami, Florida, United States

Location

1182.12.85 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

1182.12.93 Boehringer Ingelheim Investigational Site

Miami Beach, Florida, United States

Location

1182.12.17 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

1182.12.90 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Location

1182.12.63 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1182.12.78 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1182.12.94 Infectious Disease Research Institute

Tampa, Florida, United States

Location

1182.12.67 Boehringer Ingelheim Investigational Site

Vero Beach, Florida, United States

Location

1182.12.123 Infectious Disease Clinics of Emory

Atlanta, Georgia, United States

Location

1182.12.88 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1182.12.72 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1182.12.47 Boehringer Ingelheim Investigational Site

Macon, Georgia, United States

Location

1182.12.8 Family Practice Medical Center

Boise, Idaho, United States

Location

1182.12.105 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1182.12.3 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1182.12.49 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

1182.12.32 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

1182.12.48 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

1182.12.33 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

1182.12.44 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

1182.12.95 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

1182.12.81 Boehringer Ingelheim Investigational Site

Portland, Maine, United States

Location

1182.12.30 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1182.12.6 Boehringer Ingelheim Investigational Site

Bethesda, Maryland, United States

Location

1182.12.100 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1182.12.101 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1182.12.41 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

1182.12.61 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

Location

1182.12.13 University of Michigan Health System

Ann Arbor, Michigan, United States

Location

1182.12.54 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

1182.12.56 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

1182.12.120 Department of Medicine, HIV/AIDS Program

Minneapolis, Minnesota, United States

Location

1182.12.14 Dybedal Center for Clinical Research

Kansas City, Missouri, United States

Location

1182.12.87 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1182.12.11 Wellness Center

Las Vegas, Nevada, United States

Location

1182.12.4 Boehringer Ingelheim Investigational Site

Camden, New Jersey, United States

Location

1182.12.21 Boehringer Ingelheim Investigational Site

East Orange, New Jersey, United States

Location

1182.12.40 Boehringer Ingelheim Investigational Site

Santa Fe, New Mexico, United States

Location

1182.12.68 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Location

1182.12.34 Boehringer Ingelheim Investigational Site

Mount Vernon, New York, United States

Location

1182.12.119 Boehringer Ingelheim Investigational Site