Tipranavir/Ritonavir vs. Genotypically Defined Protease Inhibitor/Ritonavir in HIV Patients (RESIST-2)
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria: 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, 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). Exclusion Criteria: 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 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.
Sites / Locations
- 1182.48.5401 Fundación Huésped
- 1182.48.5402 Fundación Huésped
- 1182.48.5403 Servicio de Infecciosas
- 1182.48.5404 Servicio de Infecciosas
- 1182.48.5405 Hospital Muniz
- 1182.48.5406 Servicio de Immunocomprometido
- 1182.48.4301 Boehringer Ingelheim Investigational Site
- 1182.48.3209 Boehringer Ingelheim Investigational Site
- 1182.48.3201 Boehringer Ingelheim Investigational Site
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- 1182.48.3206 Boehringer Ingelheim Investigational Site
- 1182.48.3207 Boehringer Ingelheim Investigational Site
- 1182.48.3210 Boehringer Ingelheim Investigational Site
- 1182.48.5512 Cidade Universitária Zeferino Vaz-Clínica Médica FCM
- 1182.48.5505 Instituto A-Z de Pesquisa e Ensino da PUC
- 1182.48.5507 Hospital Geral de Nova Iguaçu - Ministério da Saúde
- 1182.48.5502 Fundação Oswaldo Cruz
- 1182.48.5509 Universidade Federal do Rio de Janeiro
- 1182.48.5511 Universidade Federal da Bahia-Unidade Docente Assistencial d
- 1182.48.5501 Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia
- 1182.48.5503 I.I. Emilio Ribas - Moléstias Infecciosas
- 1182.48.5504 Hospital do Servidor Público Estadual - IAMSPE
- 1182.48.5506 Centro de Referência e Treinamento - DST/AIDS
- 1182.48.5508 I.I. Emilio Ribas
- 1182.48.5510 INCOR e Hospital das Clínicas da Universidade de São Paulo
- 1182.48.5513 UNIFESP - Centro de Pesquisa Clinica
- 1182.48.4505 Boehringer Ingelheim Investigational Site
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- 1182.48.4911 Boehringer Ingelheim Investigational Site
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- 1182.48.3531 Boehringer Ingelheim Investigational Site
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- 1182.48.3932 Boehringer Ingelheim Investigational Site
- 1182.48.3908 Boehringer Ingelheim Investigational Site
- 1182.48.3929 Boehringer Ingelheim Investigational Site
- 1182.48.3917 Boehringer Ingelheim Investigational Site
- 1182.48.3919 Boehringer Ingelheim Investigational Site
- 1182.48.3905 Boehringer Ingelheim Investigational Site
- 1182.48.3927 Boehringer Ingelheim Investigational Site
- 1182.48.3925 Boehringer Ingelheim Investigational Site
- 1182.48.3910 Boehringer Ingelheim Investigational Site
- 1182.48.3901 Boehringer Ingelheim Investigational Site
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- 1182.48.3931 Boehringer Ingelheim Investigational Site
- 1182.48.3933 Boehringer Ingelheim Investigational Site
- 1182.48.5201 Centro Médico La Raza IMSS
- 1182.48.5202 Hospital Lopez Mateos
- 1182.48.5203 Centro Guadalajara, Jal.
- 1182.48.5206 Centro Medico San Vicente
- 1182.48.3101 Boehringer Ingelheim Investigational Site
- 1182.48.3106 Boehringer Ingelheim Investigational Site
- 1182.48.3110 Boehringer Ingelheim Investigational Site
- 1182.48.3108 Boehringer Ingelheim Investigational Site
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- 1182.48.3104 Boehringer Ingelheim Investigational Site
- 1182.48.3502 Boehringer Ingelheim Investigational Site
- 1182.48.3503 Boehringer Ingelheim Investigational Site
- 1182.48.3501 Boehringer Ingelheim Investigational Site
- 1182.48.3505 Hospital Egas Moniz
- 1182.48.3504 Hospital de São João
- 1182.48.3415 Boehringer Ingelheim Investigational Site
- 1182.48.3405 Boehringer Ingelheim Investigational Site
- 1182.48.3401 Boehringer Ingelheim Investigational Site
- 1182.48.3407 Boehringer Ingelheim Investigational Site
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- 1182.48.3402 Boehringer Ingelheim Investigational Site
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- 1182.48.3404 Boehringer Ingelheim Investigational Site
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- 1182.48.4603 Boehringer Ingelheim Investigational Site
- 1182.48.4602 Boehringer Ingelheim Investigational Site
- 1182.48.4601 Boehringer Ingelheim Investigational Site
- 1182.48.4101 Universitätsspital Basel
- 1182.48.4104 Hopital Universitaire de Genève
- 1182.48.4103 Kantonsspital St. Gallen
- 1182.48.4102 Universitätsspital Zürich
- 1182.48.4405 Boehringer Ingelheim Investigational Site
- 1182.48.4412 Boehringer Ingelheim Investigational Site
- 1182.48.4411 Boehringer Ingelheim Investigational Site
- 1182.48.4404 Boehringer Ingelheim Investigational Site
- 1182.48.4406 Boehringer Ingelheim Investigational Site
- 1182.48.4408 Boehringer Ingelheim Investigational Site
- 1182.48.4409 Boehringer Ingelheim Investigational Site
- 1182.48.4414 Boehringer Ingelheim Investigational Site
- 1182.48.4418 Boehringer Ingelheim Investigational Site
- 1182.48.4417 Boehringer Ingelheim Investigational Site
- 1182.48.4407 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Other
Other
Tipranavir(TPV)/low dose ritonavir(r)
Comparator protease inhibitor(CPI)/low dose ritonavir(r)