- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00043953
Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
26. september 2007 opdateret af: Abbott
A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ottawa, Canada, K1H 8L6
- University of Ottawa Health Research Institute
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Ottawa,, Canada, K1H 8L6
- University of Ottawa at the Ottawa Health Research Institute
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California
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Los Angeles, California, Forenede Stater, 90015
- AHF Research
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San Francisco, California, Forenede Stater, 94115
- Pacific Horizon Medical Group
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San Francisco,, California, Forenede Stater, 94115
- Stephen Becker, MD
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Torrance, California, Forenede Stater, 90502
- Harbor UCLA, Research & Education Institute
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Massachusetts
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Boston,, Massachusetts, Forenede Stater, 02215
- Community Research Initiative of New England
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Springfield, Massachusetts, Forenede Stater, 01107
- Community Research Initiative of New England
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7215
- The University of North Carolina at Chapel Hill
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Chapel Hill,, North Carolina, Forenede Stater, 27599
- University of North Carolina at Chapel Hill
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subject is naïve to antiretroviral treatment (subjects may not have more than 7 days of any antiretroviral treatment).
- Subject is at least 18 years of age, inclusive.
- If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:condoms, sponge, foams, jellies, diaphragm or intrauterine device(IUD), a vasectomized partner, total abstinence from sexual intercourse
- If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative.
- Subject is not breast-feeding.
- Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
- Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would in the opinion of the investigator adversely affect his/her participating in this study.
- Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin, simvastatin, and St. John's wort.
- Subject agrees not to take any medication during the study, including over-the-counter medicine, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
- Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening.
- Subject has a plasma HIV RNA level of greater than 400 copies/mL at screening.
- Subject agrees to take all doses of the study drug from the bottles provided by the sponsor (rather than other containers, i.e., "pill box").
- Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
Exclusion Criteria:
- Subject has a history of an allergic reaction or significant sensitivity to LPV/r, INV or Combivir.
- Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol.
Screening laboratory analyses show any of the following abnormal laboratory results:
- Hemoglobin ≤ 10.0 g/dL
- Absolute neutrophil count ≤ 1000 cells/µL
- Platelet count ≤ 50,000 per mL
- ALT or AST ≥ 3.0 x Upper Limit of Normal (ULN)
- Creatinine ≥ 1.5 x Upper Limit of Normal (ULN)
- Subject has received any investigational drug within 30 days prior to study drug administration.
- For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Proportion of subjects with plasma HIV RNA level below 50 copies/mL
Tidsramme: 48 weeks
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48 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Barbara A da Silva, M.D., Associate Medical Director, Antiviral Global Project Team
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2002
Datoer for studieregistrering
Først indsendt
15. august 2002
Først indsendt, der opfyldte QC-kriterier
16. august 2002
Først opslået (Skøn)
19. august 2002
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. september 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. september 2007
Sidst verificeret
1. september 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- Lentivirus infektioner
- Retroviridae infektioner
- Immunologiske mangelsyndromer
- Sygdomme i immunsystemet
- HIV-infektioner
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Reverse transkriptasehæmmere
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Antimetabolitter
- Proteasehæmmere
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Ritonavir
- Lopinavir
- Lamivudin
- Zidovudin
- Saquinavir
- Lamivudin, zidovudin lægemiddelkombination
Andre undersøgelses-id-numre
- M01-384
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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