HIV InfectionsPhase 3NCT00144170

Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)

A Phase 3 study testing Tipranavir (with low dose ritonavir) and Comparator protease inhibitor(CPI)/low dose ritonavir(r) in people with HIV Infections, run by Boehringer Ingelheim at 174 sites in 17 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

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Tipranavir (with low dose ritonavir) and Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 882 participants
Where: 174 sitesin 17 countries
Study dates: Feb 2003to Oct 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

Signed informed consent prior to trial participation.
Human immunodeficiency virus-1 infected males or females >=18 years of age.
Screening genotypic resistance report indicating both of the following:
at least one primary protease 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.
At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history,

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with at least 2 Protease inhibitor-based regimens (minimum 3 months of exposure of each), one of which must be part of the current regimen, and
current Protease inhibitor-based antiretroviral medication regimen for at least 3 months prior to randomisation.
Human immunodeficiency virus-1 viral load >=1000 copies/mL at screening.
Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
Total cholesterol <=400 mg/dl or 10,36 mm/L.
Total triglycerides <=750 mg/dl or 8,5 mm/L.
Alanine aminotransferase <=3x upper limit of normal and aspartate aminotransferase <=2.5x upper limit of normal.
Any Grade gamma-glutamyl transpeptidase is acceptable.
Any Grade creatinine kinase is acceptable as long as there is no concurrent myopathy.
All other laboratory test values <= Grade 1(Division of Acquired immune deficiency syndrome, National Institute of Health grading scale).
Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation.
Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
A prior Acquired immune deficiency syndrome-defining event is acceptable as long as it has resolved or the patient has been on stable treatment for at least 2 months (Acquired immune deficiency syndrome related complex is acceptable).

Who cannot join

Antiretroviral medication naïve.
Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months.
Alanine aminotransferase >3x upper limit of normal and aspartate aminotransferase >2.5x upper limit of normal at either screening visit.
Female patients of child-bearing potential who:
have a positive serum pregnancy test at screening or during the study,
are breast feeding

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are planning to become pregnant, or
are not willing to use a barrier method of contraception, or
require ethinyl estradiol administration
Prior tipranavir use.
Use of investigational medications within 30 days before study entry or during the trial. (T-20 [enfuvirtide] and Tenofovir (Viread), investigational at the time of writing of this protocol, will be allowed.)
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.

Trial locations and contacts

174 sites in 17 countries.

Country

City, postcode or hospital

174 sites in 17 countries

Italy30 sites

1182.48.3930 Boehringer Ingelheim Investigational Site
Ancona
1182.48.3920 Boehringer Ingelheim Investigational Site
Antella (fi)
1182.48.3926 Boehringer Ingelheim Investigational Site
Bari
1182.48.3932 Boehringer Ingelheim Investigational Site
Bergamo
1182.48.3908 Boehringer Ingelheim Investigational Site
Brescia
1182.48.3929 Boehringer Ingelheim Investigational Site
Busto Arsizio (va)
1182.48.3917 Boehringer Ingelheim Investigational Site
Ferrara
1182.48.3919 Boehringer Ingelheim Investigational Site
Florence
1182.48.3905 Boehringer Ingelheim Investigational Site
Genova
1182.48.3927 Boehringer Ingelheim Investigational Site
Genova
1182.48.3925 Boehringer Ingelheim Investigational Site
Lecco
1182.48.3901 Boehringer Ingelheim Investigational Site
Milan
1182.48.3907 Boehringer Ingelheim Investigational Site
Milan
1182.48.3924 Boehringer Ingelheim Investigational Site
Milan
1182.48.3934 Boehringer Ingelheim Investigational Site
Milan
1182.48.3915 Boehringer Ingelheim Investigational Site
Modena
1182.48.3912 Boehringer Ingelheim Investigational Site
Naples
1182.48.3921 Boehringer Ingelheim Investigational Site
Padova
1182.48.3916 Boehringer Ingelheim Investigational Site
Pavia
1182.48.3922 Boehringer Ingelheim Investigational Site
Pavia
1182.48.3910 Boehringer Ingelheim Investigational Site
Province of Macerata
1182.48.3904 Boehringer Ingelheim Investigational Site
Rimini
1182.48.3902 Boehringer Ingelheim Investigational Site
Roma
1182.48.3903 Boehringer Ingelheim Investigational Site
Roma
1182.48.3909 Boehringer Ingelheim Investigational Site
Roma
1182.48.3935 Boehringer Ingelheim Investigational Site
Roma
1182.48.3906 Boehringer Ingelheim Investigational Site
Torino
1182.48.3914 Boehringer Ingelheim Investigational Site
Torino
1182.48.3931 Boehringer Ingelheim Investigational Site
Torino
1182.48.3933 Boehringer Ingelheim Investigational Site
Treviso

Other trials in Italy

Germany28 sites

1182.48.4911 Boehringer Ingelheim Investigational Site
Aachen
1182.48.4901 Boehringer Ingelheim Investigational Site
Berlin
1182.48.4902 Boehringer Ingelheim Investigational Site
Berlin
1182.48.4903 Boehringer Ingelheim Investigational Site
Bochum
1182.48.4918 Boehringer Ingelheim Investigational Site
Bonn
1182.48.4905 Boehringer Ingelheim Investigational Site
Cologne
1182.48.4926 Boehringer Ingelheim Investigational Site
Cologne
1182.48.4906 Boehringer Ingelheim Investigational Site
Dortmund
1182.48.4912 Boehringer Ingelheim Investigational Site
Düsseldorf
1182.48.4914 Boehringer Ingelheim Investigational Site
Düsseldorf
1182.48.4908 Boehringer Ingelheim Investigational Site
Erlangen
1182.48.4904 Boehringer Ingelheim Investigational Site
Essen
1182.48.4924 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1182.48.4928 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
1182.48.4930 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau
1182.48.4916 Boehringer Ingelheim Investigational Site
Hamburg
1182.48.4929 Boehringer Ingelheim Investigational Site
Hamburg
1182.48.4931 Boehringer Ingelheim Investigational Site
Hamburg
1182.48.4913 Boehringer Ingelheim Investigational Site
Hanover
1182.48.4920 Boehringer Ingelheim Investigational Site
Hanover
1182.48.4909 Boehringer Ingelheim Investigational Site
Heidelberg
1182.48.4923 Boehringer Ingelheim Investigational Site
Mannheim
1182.48.4907 Boehringer Ingelheim Investigational Site
München
1182.48.4910 Boehringer Ingelheim Investigational Site
München
1182.48.4915 Boehringer Ingelheim Investigational Site
Osnabrück
1182.48.4919 Boehringer Ingelheim Investigational Site
Regensburg
1182.48.4921 Boehringer Ingelheim Investigational Site
Stuttgart
1182.48.4927 Boehringer Ingelheim Investigational Site
Stuttgart

Other trials in Germany

France23 sites

1182.48.3311 Boehringer Ingelheim Investigational Site
Besançon
1182.48.3307 Boehringer Ingelheim Investigational Site
Bordeaux
1182.48.3317 Boehringer Ingelheim Investigational Site
Bordeaux
1182.48.3302 Boehringer Ingelheim Investigational Site
Caen
1182.48.3303 Boehringer Ingelheim Investigational Site
Clamart
1182.48.3305 Boehringer Ingelheim Investigational Site
Le Kremlin-Bicêtre
1182.48.3304 Boehringer Ingelheim Investigational Site
Lyon
1182.48.3322 Boehringer Ingelheim Investigational Site
Lyon
1182.48.3308 Boehringer Ingelheim Investigational Site
Marseille
1182.48.3309 Boehringer Ingelheim Investigational Site
Marseille
1182.48.3318 Boehringer Ingelheim Investigational Site
Nantes
1182.48.3306 Boehringer Ingelheim Investigational Site
Nice
1182.48.3301 Boehringer Ingelheim Investigational Site
Paris
1182.48.3310 Boehringer Ingelheim Investigational Site
Paris
1182.48.3312 Boehringer Ingelheim Investigational Site
Paris
1182.48.3316 Boehringer Ingelheim Investigational Site
Paris
1182.48.3319 Boehringer Ingelheim Investigational Site
Paris
1182.48.3321 Boehringer Ingelheim Investigational Site
Paris
1182.48.3323 Boehringer Ingelheim Investigational Site
Paris
1182.48.3315 Boehringer Ingelheim Investigational Site
Rennes
1182.48.3313 Boehringer Ingelheim Investigational Site
Strasbourg
1182.48.3314 Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy
1182.48.3320 Boehringer Ingelheim Investigational Site
Villejuif

Other trials in France

Spain19 sites

1182.48.3415 Boehringer Ingelheim Investigational Site
Alicante
1182.48.3405 Boehringer Ingelheim Investigational Site
Badalona
1182.48.3401 Boehringer Ingelheim Investigational Site
Barcelona
1182.48.3407 Boehringer Ingelheim Investigational Site
Barcelona
1182.48.3408 Boehringer Ingelheim Investigational Site
Barcelona
1182.48.3409 Boehringer Ingelheim Investigational Site
Barcelona
1182.48.3416 Boehringer Ingelheim Investigational Site
Donostia / San Sebastian
1182.48.3406 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1182.48.3402 Boehringer Ingelheim Investigational Site
Madrid
1182.48.3403 Boehringer Ingelheim Investigational Site
Madrid
1182.48.3404 Boehringer Ingelheim Investigational Site
Madrid
1182.48.3410 Boehringer Ingelheim Investigational Site
Madrid
1182.48.3411 Boehringer Ingelheim Investigational Site
Madrid
1182.48.3412 Boehringer Ingelheim Investigational Site
Madrid
1182.48.3417 Boehringer Ingelheim Investigational Site
Málaga
1182.48.3413 Boehringer Ingelheim Investigational Site
Seville
1182.48.3414 Boehringer Ingelheim Investigational Site
Valencia
1182.48.3420 Boehringer Ingelheim Investigational Site
Valencia
1182.48.3418 Boehringer Ingelheim Investigational Site
Vigo

Other trials in Spain

Brazil13 sites

1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM
Campinas - SP
1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC
Curitiba - PR
1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
Nova Iguaçu - RJ
1182.48.5502 Fundação Oswaldo Cruz
Rio de Janeiro - RJ
1182.48.5509 Universidade Federal do Rio de Janeiro
Rio de Janeiro - RJ
1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d
Salvador - BA
1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
São Paulo - SP
1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas
São Paulo - SP
1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE
São Paulo - SP
1182.48.5506 Centro de Referência e Treinamento - DST/AIDS
São Paulo - SP
1182.48.5508 I.I. Emilio Ribas
São Paulo - SP
1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo
São Paulo - SP
1182.48.5513 UNIFESP - Centro de Pesquisa Clinica
São Paulo - SP

Other trials in Brazil

United Kingdom11 sites

1182.48.4405 Boehringer Ingelheim Investigational Site
Brighton
1182.48.4412 Boehringer Ingelheim Investigational Site
Edinburgh
1182.48.4411 Boehringer Ingelheim Investigational Site
Liverpool
1182.48.4404 Boehringer Ingelheim Investigational Site
London
1182.48.4406 Boehringer Ingelheim Investigational Site
London
1182.48.4408 Boehringer Ingelheim Investigational Site
London
1182.48.4409 Boehringer Ingelheim Investigational Site
London
1182.48.4414 Boehringer Ingelheim Investigational Site
London
1182.48.4418 Boehringer Ingelheim Investigational Site
London
1182.48.4417 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne
1182.48.4407 Boehringer Ingelheim Investigational Site
Portsmouth

Other trials in United Kingdom

Greece10 sites

1182.48.3001 Boehringer Ingelheim Investigational Site
Athens
1182.48.3002 Boehringer Ingelheim Investigational Site
Athens
1182.48.3003 Boehringer Ingelheim Investigational Site
Athens
1182.48.3004 Boehringer Ingelheim Investigational Site
Athens
1182.48.3006 Boehringer Ingelheim Investigational Site
Athens
1182.48.3007 Boehringer Ingelheim Investigational Site
Athens
1182.48.3005 Boehringer Ingelheim Investigational Site
Goudi, Athens
1182.48.3010 Boehringer Ingelheim Investigational Site
Pátrai
1182.48.3008 Boehringer Ingelheim Investigational Site
Peraeus
1182.48.3009 Boehringer Ingelheim Investigational Site
Thessaloniki

Other trials in Greece

Argentina6 sites

1182.48.5401 Fundación Huésped
Buenos Aires
1182.48.5402 Fundación Huésped
Buenos Aires
1182.48.5403 Servicio de Infecciosas
Buenos Aires
1182.48.5404 Servicio de Infecciosas
Buenos Aires
1182.48.5405 Hospital Muniz
Buenos Aires
1182.48.5406 Servicio de Immunocomprometido
Buenos Aires

Other trials in Argentina

Belgium6 sites

1182.48.3209 Boehringer Ingelheim Investigational Site
Antwerp
1182.48.3201 Boehringer Ingelheim Investigational Site
Brussels
1182.48.3202 Boehringer Ingelheim Investigational Site
Brussels
1182.48.3206 Boehringer Ingelheim Investigational Site
Charleroi
1182.48.3207 Boehringer Ingelheim Investigational Site
Ghent
1182.48.3210 Boehringer Ingelheim Investigational Site
Luxembourg

Other trials in Belgium

Netherlands6 sites

1182.48.3101 Boehringer Ingelheim Investigational Site
Amsterdam
1182.48.3106 Boehringer Ingelheim Investigational Site
Amsterdam
1182.48.3108 Boehringer Ingelheim Investigational Site
Groningen
1182.48.3105 Boehringer Ingelheim Investigational Site
Nijmegen
1182.48.3104 Boehringer Ingelheim Investigational Site
Rotterdam
1182.48.3110 Boehringer Ingelheim Investigational Site
The Hague

Other trials in Netherlands

Portugal5 sites

1182.48.3502 Boehringer Ingelheim Investigational Site
Cascais
1182.48.3503 Boehringer Ingelheim Investigational Site
Coimbra
1182.48.3501 Boehringer Ingelheim Investigational Site
Lisbon
1182.48.3505 Hospital Egas Moniz
Lisbon
1182.48.3504 Hospital de São João
Porto

Other trials in Portugal

Denmark4 sites

1182.48.4505 Boehringer Ingelheim Investigational Site
Aarhus N
1182.48.4502 Boehringer Ingelheim Investigational Site
Hvidovre
1182.48.4501 Boehringer Ingelheim Investigational Site
København Ø
1182.48.4504 Boehringer Ingelheim Investigational Site
Odense C

Other trials in Denmark

Mexico4 sites

1182.48.5202 Hospital Lopez Mateos
México
1182.48.5203 Centro Guadalajara, Jal.
México
1182.48.5201 Centro Médico La Raza IMSS
Mexico City
1182.48.5206 Centro Medico San Vicente
Monterrey, N.l.

Other trials in Mexico

Switzerland4 sites

1182.48.4101 Universitätsspital Basel
Basel
1182.48.4104 Hopital Universitaire de Genève
Geneva
1182.48.4103 Kantonsspital St. Gallen
Sankt Gallen
1182.48.4102 Universitätsspital Zürich
Zurich

Other trials in Switzerland

Sweden3 sites

1182.48.4603 Boehringer Ingelheim Investigational Site
Gothenburg
1182.48.4602 Boehringer Ingelheim Investigational Site
Malmö
1182.48.4601 Boehringer Ingelheim Investigational Site
Stockholm

Other trials in Sweden

Austria1 site

1182.48.4301 Boehringer Ingelheim Investigational Site
Vienna

Other trials in Austria

Ireland1 site

1182.48.3531 Boehringer Ingelheim Investigational Site
Dublin

Other trials in Ireland

About this study

Official title: Randomized, Open-label, Comparative Safety and Efficacy Study of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) Versus Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)

The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load > =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.

Conditions: HIV Infections
Being tested: Tipranavir (with low dose ritonavir), Comparator protease inhibitor(CPI)/low dose ritonavir(r)
Medical subject headings: HIV Infections

What participants receive

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

Tipranavir (with low dose ritonavir)Drug
Comparator protease inhibitor(CPI)/low dose ritonavir(r)Drug

Study groups in NCT00144170
Study group	Role	What they receive
Tipranavir(TPV)/low dose ritonavir(r)	Other	Not described Receives: Drug: Tipranavir (with low dose ritonavir)
Comparator protease inhibitor(CPI)/low dose ritonavir(r)	Other	Not described Receives: Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

What is being measured

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

Treatment Response at Week 48
Patients who experienced treatment response. 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: after 48 weeks of treatment
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 Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.
Measured: after 48 weeks of treatment

Secondary outcomes (90)

Treatment Response at Week 2
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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 24
Patients who experienced treatment response. 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 32
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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 56
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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
Patients who experienced treatment response. 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: after 96 weeks of treatment
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 Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.
Measured: after 96 weeks of treatment
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 where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.
Measured: after 48 weeks of treatment
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 where the Log(baseline viral load)-Log(on-treatment viral load)>1 before a 2 consecutive measurements where Log(baseline viral load)-Log(on-treatment viral load)<1.
Measured: after 96 weeks of treatment
Virologic Response
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: Week 2 through Week 96 (at any point during trial)
Virologic Response at Week 2
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: Week 2
Virologic Response at Week 4
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 4
Virologic Response at Week 8
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 8
Virologic Response at Week 16
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 16
Virologic Response at Week 24
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 24
Virologic Response at Week 32
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 32
Virologic Response at Week 40
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 40
Virologic Response at Week 48
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 48
Virologic Response at Week 56
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 56
Virologic Response at Week 64
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: week 64
Virologic Response at Week 72
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: Week 72
Virologic Response at Week 80
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: Week 80
Virologic Response at Week 88
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: Week 88
Virologic Response at Week 96
Virologic response is defined as: Log(baseline viral load (VL))-Log(on-treatment VL)>=1
Measured: Week 96
Median Change From Baseline in Viral Load (Week 2)
Measured: Baseline to Week 2
Median Change From Baseline in Viral Load (Week 4)
Measured: Baseline to Week 4
Median Change From Baseline in Viral Load (Week 8)
Measured: Baseline to Week 8
Median Change From Baseline in Viral Load (Week 16)
Measured: Baseline to Week 16
Median Change From Baseline in Viral Load (Week 24)
Measured: Baseline to Week 24
Median Change From Baseline in Viral Load (Week 32)
Measured: Baseline to Week 32
Median Change From Baseline in Viral Load (Week 40)
Measured: Baseline to Week 40
Median Change From Baseline in Viral Load (Week 48)
Measured: Baseline to Week 48
Median Change From Baseline in Viral Load (Week 56)
Measured: Baseline to Week 56
Median Change From Baseline in Viral Load (Week 64)
Measured: Baseline to Week 64
Median Change From Baseline in Viral Load (Week 72)
Measured: Baseline to Week 72
Median Change From Baseline in Viral Load (Week 80)
Measured: Baseline to Week 80
Median Change From Baseline in Viral Load (Week 88)
Measured: Baseline to Week 88
Median Change From Baseline in Viral Load (Week 96)
Measured: Baseline to Week 96
Virologic Response at Week 40
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 40
Virologic Response at Viral Load Nadir During Study Treatment Through 96 Weeks
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 2 through Week 96 (at any point during trial)
Virologic Response at Week 2
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 2
Virologic Response at Week 4
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 4
Virologic Response at Week 8
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 8
Virologic Response at Week 16
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 16
Virologic Response at Week 24
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 24
Virologic Response at Week 32
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 32
Virologic Response at Week 48
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 48
Virologic Response at Week 56
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 56
Virologic Response at Week 64
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 64
Virologic Response at Week 72
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 72
Virologic Response at Week 80
Virologic response defined as Viral Load<400 copies/mL
Measured: Week 80
Virologic Response at Week 88
Virologic response defined as Viral Load<400 copies/mL
Measured: week 88
Virologic Response at Week 96
Virologic response defined as Viral Load<400 copies/mL
Measured: week 96
Virologic Response
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 2 through Week 96 (at any point during trial)
Virologic Response at Week 2
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 2
Virologic Response at Week 4
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 4
Virologic Response at Week 8
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 8
Virologic Response at Week 16
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 16
Virologic Response at Week 24
Viral Load < 50 copies/mL
Measured: Week 24
Virologic Response at Week 32
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 32
Virologic Response at Week 40
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 40
Virologic Response at Week 48
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 48
Virologic Response at Week 56
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 56
Virologic Response at Week 64
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 64
Virologic Response at Week 72
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 72
Virologic Response at Week 80
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 80
Virologic Response at Week 88
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 88
Virologic Response at Week 96
Virologic response defined as Viral Load<50 copies/mL
Measured: Week 96
Mean Change From Baseline in CD4+ Cell Count (Week 2)
Measured: Baseline to Week 2
Mean Change From Baseline in CD4+ Cell Count (Week 4)
Measured: Baseline to Week 4
Mean Change From Baseline in CD4+ Cell Count (Week 8)
Measured: Baseline to Week 8
Mean Change From Baseline in CD4+ Cell Count (Week 16)
Measured: Baseline to Week 16
Mean Change From Baseline in CD4+ Cell Count (Week 24)
Measured: Baseline to Week 24
Mean Change From Baseline in CD4+ Cell Count (Week 32)
Measured: Baseline to Week 32
Mean Change From Baseline in CD4+ Cell Count (Week 40)
Measured: Baseline to Week 40
Mean Change From Baseline in CD4+ Cell Count (Week 48)
Measured: Baseline to Week 48
Mean Change From Baseline in CD4+ Cell Count (Week 56)
Measured: Baseline to Week 56
Mean Change From Baseline in CD4+ Cell Count (Week 64)
Measured: Baseline to Week 64
Mean Change From Baseline in CD4+ Cell Count (Week 72)
Measured: Baseline to Week 72
Mean Change From Baseline in CD4+ Cell Count (Week 80)
Measured: Baseline to Week 80
Mean Change From Baseline in CD4+ Cell Count (Week 88)
Measured: Baseline to Week 88
Mean Change From Baseline in CD4+ Cell Count (Week 96)
Measured: Baseline to Week 96
Time to New Centers for Disease Control (CDC) Class C Progression Event or Death.
Time to death or occurrence of AIDS-defining condition according to the US Centers for Disease Control and Prevention case definition.
The median and quartiles are underestimated since more than 92% of the observations (in both treatment arms) were censored and the estimation was restricted to the largest observed event time.
Measured: up to 75 weeks of treatment

Timeline

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

Feb 2003Oct 2008

First posted5 Sep 2005 (estimated)
Study startFeb 2003
Primary completionOct 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 (2)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: 882 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00144170
Sponsor's protocol ID: 1182.48
Other IDs: RESIST 2
Status last verified: Apr 2014
First submitted: 2 Sep 2005
Last updated: 2 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Mikl J, Sulkowski MS, Benhamou Y, Dieterich D, Pol S, Rockstroh J, Robinson PA, Ranga M, Stern JO. Hepatic profile analyses of tipranavir in Phase II and III clinical trials. BMC Infect Dis. 2009 Dec 14;9:203. doi: 10.1186/1471-2334-9-203.
PubMed 20003457
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?

See locations

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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) Versus Genotypically-defined Protease Inhibitor/Ritonavir (PI/RTV) in Multiple Antiretroviral Drug-experienced Patients (RESIST 2: Randomized Evaluation of Strategic Intervention in Multi-Drug Resistant Patients With Tipranavir)
ClinicalTrials.gov ID: NCT00144170
Acronym / sponsor ID: 1182.48
Conditions: HIV Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 882 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2003
Primary completion: Oct 2008 (actual)
First posted: 5 Sep 2005 (estimated)
Results: Posted 23 Dec 2009

Clinical summary

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

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 (with low dose ritonavir)
Comparator protease inhibitor(CPI)/low dose ritonavir(r)	Other	Drug: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

Who may qualify

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

Key inclusion criteria (19 listed)

Signed informed consent prior to trial participation.
Human immunodeficiency virus-1 infected males or females >=18 years of age.
Screening genotypic resistance report indicating both of the following:
At least 3 consecutive months experience taking antiretrovirals from each of the classes of Nucleoside reverse transcriptase inhibitor(s), Non-nucleoside reverse transcriptase inhibitor(s), and Protease inhibitor(s) at some point in treatment history,
Human immunodeficiency virus-1 viral load >=1000 copies/mL at screening.

Key exclusion criteria (14 listed)

Antiretroviral medication naïve.
Patients on recent drug holiday, defined as off antiretroviral medications for at least 7 consecutive days within the last 3 months.
Alanine aminotransferase >3x upper limit of normal and aspartate aminotransferase >2.5x upper limit of normal at either screening visit.
Female patients of child-bearing potential who:
Prior tipranavir use.

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 (with low dose ritonavir)	Drug	Tipranavir(TPV)/low dose ritonavir(r)
Comparator protease inhibitor(CPI)/low dose ritonavir(r)	Drug	Comparator protease inhibitor(CPI)/low dose ritonavir(r)

Primary outcome

Treatment Response at Week 48
Time frame: after 48 weeks of treatment
Patients who experienced treatment response. 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: after 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 Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.

90 secondary outcomes

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 24
Time frame: Week 24
Treatment Response at Week 32
Time frame: week 32
Treatment Response at Week 40
Time frame: week 40
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: after 96 weeks of treatment
Time to Treatment Failure Through 96 Weeks of Treatment
Time frame: after 96 weeks of treatment
Time to Confirmed Virologic Failure Through 48 Weeks of Treatment
Time frame: after 48 weeks of treatment
Time to Confirmed Virologic Failure Through 96 Weeks of Treatment
Time frame: after 96 weeks of treatment
Virologic Response
Time frame: Week 2 through Week 96 (at any point during trial)
Virologic Response at Week 2
Time frame: Week 2
Virologic Response at Week 4
Time frame: week 4
Virologic Response at Week 8
Time frame: week 8
Virologic Response at Week 16
Time frame: week 16
Virologic Response at Week 24
Time frame: week 24
Virologic Response at Week 32
Time frame: week 32
Virologic Response at Week 40
Time frame: week 40
Virologic Response at Week 48
Time frame: week 48
Virologic Response at Week 56
Time frame: week 56
Virologic Response at Week 64
Time frame: week 64
Virologic Response at Week 72
Time frame: Week 72
Virologic Response at Week 80
Time frame: Week 80
Virologic Response at Week 88
Time frame: Week 88
Virologic Response at Week 96
Time frame: Week 96
Median Change From Baseline in Viral Load (Week 2)
Time frame: Baseline to Week 2
Median Change From Baseline in Viral Load (Week 4)
Time frame: Baseline to Week 4
Median Change From Baseline in Viral Load (Week 8)
Time frame: Baseline to Week 8
Median Change From Baseline in Viral Load (Week 16)
Time frame: Baseline to Week 16
Median Change From Baseline in Viral Load (Week 24)
Time frame: Baseline to Week 24
Median Change From Baseline in Viral Load (Week 32)
Time frame: Baseline to Week 32
Median Change From Baseline in Viral Load (Week 40)
Time frame: Baseline to Week 40
Median Change From Baseline in Viral Load (Week 48)
Time frame: Baseline to Week 48
Median Change From Baseline in Viral Load (Week 56)
Time frame: Baseline to Week 56

Results and safety

Results posted to the registry on 23 Dec 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)	438	86
Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)	428	32

Primary outcome: Treatment Response at Week 48

Time frame: after 48 weeks of treatment. Number. Unit: percentage of participants

Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n = 435	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n = 428
Value	34.5	15

Tipranavir(TPV)/Low Dose Ritonavir(r) vs Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r): Risk Difference (RD): 18.5 (95% CI 12.9 to 24.0), p = 0.0001, Cochran-Mantel-Haenszel

Population analysed: Full Analysis Set (FAS), included 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: after 48 weeks of treatment. Median (Inter-Quartile Range). Unit: Days

Measure	Tipranavir(TPV)/Low Dose Ritonavir(r) n = 435	Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r) n = 428
Value	112 (0 to 475)	0 (0 to 112)

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

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

90 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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)	123 of 438 (28.1%)	359 of 438 (82%)	Not reported
Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)	89 of 428 (20.8%)	270 of 428 (63.1%)	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 20003457Mikl J, Sulkowski MS, Benhamou Y, Dieterich D, Pol S, Rockstroh J, Robinson PA, Ranga M, Stern JO. Hepatic profile analyses of tipranavir in Phase II and III clinical trials. BMC Infect Dis. 2009 Dec 14;9:203. doi: 10.1186/1471-2334-9-203.
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.

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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

174 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 inclusion and 14 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 174 sites in Italy, Germany, France, Spain, Brazil and 12 more countries. 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 23 Dec 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: after 48 weeks of treatment). 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 NCT00144170, which also lists 2 linked publications.

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.