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

NCT ID: NCT00144170

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

882 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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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.

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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 (with low dose ritonavir)

Intervention Type DRUG

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

Group Type OTHER

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

Intervention Type DRUG

Interventions

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Tipranavir (with low dose ritonavir)

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Signed informed consent prior to trial participation.
2. Human immunodeficiency virus-1 infected males or females \>=18 years of age.
3. 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.
4. 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,

* 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.
5. Human immunodeficiency virus-1 viral load \>=1000 copies/mL at screening.
6. 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).
7. Acceptable medical history, as assessed by the investigator, with chest X-ray and electrocardiogram within 1 year of study participation.
8. Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
9. 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).

Exclusion Criteria

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

* have a positive serum pregnancy test at screening or during the study,
* are breast feeding
* are planning to become pregnant, or
* are not willing to use a barrier method of contraception, or
* require ethinyl estradiol administration
5. Prior tipranavir use.
6. 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.)
7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
8. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
9. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
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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1182.48.5401 Fundación Huésped

Buenos Aires, , Argentina

Site Status

1182.48.5402 Fundación Huésped

Buenos Aires, , Argentina

Site Status

1182.48.5403 Servicio de Infecciosas

Buenos Aires, , Argentina

Site Status

1182.48.5404 Servicio de Infecciosas

Buenos Aires, , Argentina

Site Status

1182.48.5405 Hospital Muniz

Buenos Aires, , Argentina

Site Status

1182.48.5406 Servicio de Immunocomprometido

Buenos Aires, , Argentina

Site Status

1182.48.4301 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1182.48.3209 Boehringer Ingelheim Investigational Site

Antwerp, , Belgium

Site Status

1182.48.3201 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1182.48.3202 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1182.48.3206 Boehringer Ingelheim Investigational Site

Charleroi, , Belgium

Site Status

1182.48.3207 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

1182.48.3210 Boehringer Ingelheim Investigational Site

Luxembourg, , Belgium

Site Status

1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM

Campinas - SP, , Brazil

Site Status

1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC

Curitiba - PR, , Brazil

Site Status

1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde

Nova Iguaçu - RJ, , Brazil

Site Status

1182.48.5502 Fundação Oswaldo Cruz

Rio de Janeiro - RJ, , Brazil

Site Status

1182.48.5509 Universidade Federal do Rio de Janeiro

Rio de Janeiro - RJ, , Brazil

Site Status

1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d

Salvador - BA, , Brazil

Site Status

1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia

São Paulo - SP, , Brazil

Site Status

1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas

São Paulo - SP, , Brazil

Site Status

1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE

São Paulo - SP, , Brazil

Site Status

1182.48.5506 Centro de Referência e Treinamento - DST/AIDS

São Paulo - SP, , Brazil

Site Status

1182.48.5508 I.I. Emilio Ribas

São Paulo - SP, , Brazil

Site Status

1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo

São Paulo - SP, , Brazil

Site Status

1182.48.5513 UNIFESP - Centro de Pesquisa Clinica

São Paulo - SP, , Brazil

Site Status

1182.48.4505 Boehringer Ingelheim Investigational Site

Aarhus N, , Denmark

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1182.48.4502 Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

1182.48.4501 Boehringer Ingelheim Investigational Site

København Ø, , Denmark

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1182.48.4504 Boehringer Ingelheim Investigational Site

Odense C, , Denmark

Site Status

1182.48.3311 Boehringer Ingelheim Investigational Site

Besançon, , France

Site Status

1182.48.3307 Boehringer Ingelheim Investigational Site

Bordeaux, , France

Site Status

1182.48.3317 Boehringer Ingelheim Investigational Site

Bordeaux, , France

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1182.48.3302 Boehringer Ingelheim Investigational Site

Caen, , France

Site Status

1182.48.3303 Boehringer Ingelheim Investigational Site

Clamart, , France

Site Status

1182.48.3305 Boehringer Ingelheim Investigational Site

Le Kremlin-Bicêtre, , France

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1182.48.3304 Boehringer Ingelheim Investigational Site

Lyon, , France

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1182.48.3322 Boehringer Ingelheim Investigational Site

Lyon, , France

Site Status

1182.48.3308 Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1182.48.3309 Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1182.48.3318 Boehringer Ingelheim Investigational Site

Nantes, , France

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1182.48.3306 Boehringer Ingelheim Investigational Site

Nice, , France

Site Status

1182.48.3301 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1182.48.3310 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1182.48.3312 Boehringer Ingelheim Investigational Site

Paris, , France

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1182.48.3316 Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1182.48.3319 Boehringer Ingelheim Investigational Site

Paris, , France

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1182.48.3321 Boehringer Ingelheim Investigational Site

Paris, , France

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1182.48.3323 Boehringer Ingelheim Investigational Site

Paris, , France

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1182.48.3315 Boehringer Ingelheim Investigational Site

Rennes, , France

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1182.48.3313 Boehringer Ingelheim Investigational Site

Strasbourg, , France

Site Status

1182.48.3314 Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

1182.48.3320 Boehringer Ingelheim Investigational Site

Villejuif, , France

Site Status

1182.48.4911 Boehringer Ingelheim Investigational Site

Aachen, , Germany

Site Status

1182.48.4901 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1182.48.4902 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1182.48.4903 Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

1182.48.4918 Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

1182.48.4905 Boehringer Ingelheim Investigational Site

Cologne, , Germany

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1182.48.4926 Boehringer Ingelheim Investigational Site

Cologne, , Germany

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1182.48.4906 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

1182.48.4912 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

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1182.48.4914 Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

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1182.48.4908 Boehringer Ingelheim Investigational Site

Erlangen, , Germany

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1182.48.4904 Boehringer Ingelheim Investigational Site

Essen, , Germany

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1182.48.4924 Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

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1182.48.4928 Boehringer Ingelheim Investigational Site

Freiburg im Breisgau, , Germany

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1182.48.4930 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, , Germany

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1182.48.4916 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

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1182.48.4929 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1182.48.4931 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1182.48.4913 Boehringer Ingelheim Investigational Site

Hanover, , Germany

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1182.48.4920 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1182.48.4909 Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

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1182.48.4923 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

1182.48.4907 Boehringer Ingelheim Investigational Site

München, , Germany

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1182.48.4910 Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

1182.48.4915 Boehringer Ingelheim Investigational Site

Osnabrück, , Germany

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1182.48.4919 Boehringer Ingelheim Investigational Site

Regensburg, , Germany

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1182.48.4921 Boehringer Ingelheim Investigational Site

Stuttgart, , Germany

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1182.48.4927 Boehringer Ingelheim Investigational Site

Stuttgart, , Germany

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1182.48.3001 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1182.48.3002 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1182.48.3003 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1182.48.3004 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1182.48.3006 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1182.48.3007 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1182.48.3005 Boehringer Ingelheim Investigational Site

Goudi, Athens, , Greece

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1182.48.3010 Boehringer Ingelheim Investigational Site

Pátrai, , Greece

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1182.48.3008 Boehringer Ingelheim Investigational Site

Peraeus, , Greece

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1182.48.3009 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

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1182.48.3531 Boehringer Ingelheim Investigational Site

Dublin, , Ireland

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1182.48.3930 Boehringer Ingelheim Investigational Site

Ancona, , Italy

Site Status

1182.48.3920 Boehringer Ingelheim Investigational Site

Antella (fi), , Italy

Site Status

1182.48.3926 Boehringer Ingelheim Investigational Site

Bari, , Italy

Site Status

1182.48.3932 Boehringer Ingelheim Investigational Site

Bergamo, , Italy

Site Status

1182.48.3908 Boehringer Ingelheim Investigational Site

Brescia, , Italy

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1182.48.3929 Boehringer Ingelheim Investigational Site

Busto Arsizio (va), , Italy

Site Status

1182.48.3917 Boehringer Ingelheim Investigational Site

Ferrara, , Italy

Site Status

1182.48.3919 Boehringer Ingelheim Investigational Site

Florence, , Italy

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1182.48.3905 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

1182.48.3927 Boehringer Ingelheim Investigational Site

Genova, , Italy

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1182.48.3925 Boehringer Ingelheim Investigational Site

Lecco, , Italy

Site Status

1182.48.3910 Boehringer Ingelheim Investigational Site

Macerata, , Italy

Site Status

1182.48.3901 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1182.48.3907 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1182.48.3924 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1182.48.3934 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1182.48.3915 Boehringer Ingelheim Investigational Site

Modena, , Italy

Site Status

1182.48.3912 Boehringer Ingelheim Investigational Site

Napoli, , Italy

Site Status

1182.48.3921 Boehringer Ingelheim Investigational Site

Padua, , Italy

Site Status

1182.48.3916 Boehringer Ingelheim Investigational Site

Pavia, , Italy

Site Status

1182.48.3922 Boehringer Ingelheim Investigational Site

Pavia, , Italy

Site Status

1182.48.3904 Boehringer Ingelheim Investigational Site

Rimini, , Italy

Site Status

1182.48.3902 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1182.48.3903 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1182.48.3909 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1182.48.3935 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1182.48.3906 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

1182.48.3914 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

1182.48.3931 Boehringer Ingelheim Investigational Site

Torino, , Italy

Site Status

1182.48.3933 Boehringer Ingelheim Investigational Site

Treviso, , Italy

Site Status

1182.48.5201 Centro Médico La Raza IMSS

Mexico City, , Mexico

Site Status

1182.48.5202 Hospital Lopez Mateos

México, , Mexico

Site Status

1182.48.5203 Centro Guadalajara, Jal.

México, , Mexico

Site Status

1182.48.5206 Centro Medico San Vicente

Monterrey, N.l., , Mexico

Site Status

1182.48.3101 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1182.48.3106 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1182.48.3108 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

Site Status

1182.48.3105 Boehringer Ingelheim Investigational Site

Nijmegen, , Netherlands

Site Status

1182.48.3104 Boehringer Ingelheim Investigational Site

Rotterdam, , Netherlands

Site Status

1182.48.3110 Boehringer Ingelheim Investigational Site

The Hague, , Netherlands

Site Status

1182.48.3502 Boehringer Ingelheim Investigational Site

Cascais, , Portugal

Site Status

1182.48.3503 Boehringer Ingelheim Investigational Site

Coimbra, , Portugal

Site Status

1182.48.3501 Boehringer Ingelheim Investigational Site

Lisbon, , Portugal

Site Status

1182.48.3505 Hospital Egas Moniz

Lisbon, , Portugal

Site Status

1182.48.3504 Hospital de São João

Porto, , Portugal

Site Status

1182.48.3415 Boehringer Ingelheim Investigational Site

Alicante, , Spain

Site Status

1182.48.3405 Boehringer Ingelheim Investigational Site

Badalona, , Spain

Site Status

1182.48.3401 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1182.48.3407 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1182.48.3408 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1182.48.3409 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

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1182.48.3416 Boehringer Ingelheim Investigational Site

Donostia / San Sebastian, , Spain

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1182.48.3406 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat, , Spain

Site Status

1182.48.3402 Boehringer Ingelheim Investigational Site

Madrid, , Spain

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1182.48.3403 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1182.48.3404 Boehringer Ingelheim Investigational Site

Madrid, , Spain

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1182.48.3410 Boehringer Ingelheim Investigational Site

Madrid, , Spain

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1182.48.3411 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1182.48.3412 Boehringer Ingelheim Investigational Site

Madrid, , Spain

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1182.48.3417 Boehringer Ingelheim Investigational Site

Málaga, , Spain

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1182.48.3413 Boehringer Ingelheim Investigational Site

Seville, , Spain

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1182.48.3414 Boehringer Ingelheim Investigational Site

Valencia, , Spain

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1182.48.3420 Boehringer Ingelheim Investigational Site

Valencia, , Spain

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1182.48.3418 Boehringer Ingelheim Investigational Site

Vigo, , Spain

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1182.48.4603 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

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1182.48.4602 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

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1182.48.4601 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1182.48.4101 Universitätsspital Basel

Basel, , Switzerland

Site Status

1182.48.4104 Hopital Universitaire de Genève

Geneva, , Switzerland

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1182.48.4103 Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

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1182.48.4102 Universitätsspital Zürich

Zurich, , Switzerland

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1182.48.4405 Boehringer Ingelheim Investigational Site

Brighton, , United Kingdom

Site Status

1182.48.4412 Boehringer Ingelheim Investigational Site

Edinburgh, , United Kingdom

Site Status

1182.48.4411 Boehringer Ingelheim Investigational Site

Liverpool, , United Kingdom

Site Status

1182.48.4404 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1182.48.4406 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1182.48.4408 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1182.48.4409 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1182.48.4414 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1182.48.4418 Boehringer Ingelheim Investigational Site

London, , United Kingdom

Site Status

1182.48.4417 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

1182.48.4407 Boehringer Ingelheim Investigational Site

Portsmouth, , United Kingdom

Site Status

Countries

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Argentina Austria Belgium Brazil Denmark France Germany Greece Ireland Italy Mexico Netherlands Portugal Spain Sweden Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 20003457 (View on PubMed)

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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RESIST 2

Identifier Type: -

Identifier Source: secondary_id

1182.48

Identifier Type: -

Identifier Source: org_study_id

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Effects of Tipranavir/Ritonavir on the Pharmacokinetic Characteristics of Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects
NCT02251223 COMPLETED PHASE1/PHASE2
Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals
NCT00034866 COMPLETED PHASE2
Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone
NCT01605084 WITHDRAWN PHASE3
TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients
NCT00110877 COMPLETED PHASE3
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
NCT00234910 COMPLETED PHASE3
Safety and Antiviral Activity of TPV in HCV and/or HBV HIV Coinfected Patients TDM Randomised Pilot Evaluation
NCT00447902 TERMINATED PHASE3
A Phase IIIb Study Comparing Two Boosted Protease Inhibitor-based HAART Regimens in HIV-infected Patients Experiencing Their First Virologic Failure While Receiving an NNRTI-containing HAART Regimen
NCT00135395 COMPLETED PHASE3
Safety and Effectiveness of Lopinavir/Ritonavir in Individuals Who Have Failed Prior HIV Therapy
NCT00357552 COMPLETED NA
Clinical Trial to Assess the Security of the Dose Reduction of Ritonavir in HIV-Infected Patients in Treatment With Tipranavir/Ritonavir 500/200 mg Every 12 Hours
NCT00607958 COMPLETED PHASE4
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
NCT00654147 COMPLETED PHASE2
Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals
NCT00632970 TERMINATED PHASE4
Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir
NCT00458302 COMPLETED PHASE3