Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

26. juli 2006 opdateret af: Abbott

A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.

Studieoversigt

Status

Afsluttet

Betingelser

HIV-infektioner

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

200

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Australien
- New South Wales
  - Darlinghurst, New South Wales, Australien, 2010
    - Holdsworth House General Practice
  - Darlinghurst, New South Wales, Australien, 2010
    - Ground Zero Medical Centre / AIDS Research Initiative
Det Forenede Kongerige
- - E. Sussex, Det Forenede Kongerige, BN2 3EW
    - Brighton General Hospital
  - London, Det Forenede Kongerige, NW3 2QG
    - Royal Free Hospital
  - London, Det Forenede Kongerige, SE5 9RS
    - The Caldecot Centre King's Healthcare NHS Trust
  - London, Det Forenede Kongerige, SW10 9TH
    - St. Stephen's Centre Chelsea & Westminster Hospital
  - London, Det Forenede Kongerige, W2 1NY
    - St. Mary Hospital
Forenede Stater
- Arizona
  - Phoenix,, Arizona, Forenede Stater, 85006
    - Phoenix Body Positive
- California
  - Beverly Hills, California, Forenede Stater, 90211
    - Pacific Oaks Research
  - Fountain Valley, California, Forenede Stater, 92708
    - Orange County Center for Special Immunology
  - Long Beach, California, Forenede Stater, 90813
    - Living Hope Clinical Foundation
  - Los Angeles, California, Forenede Stater, 90027
    - AIDS Healthcare Foundation Research Center
- Florida
  - Altamonte Springs, Florida, Forenede Stater, 32701
    - IDS Research Initiative
  - Atlantis, Florida, Forenede Stater, 33462
    - South Florida Clinical Research
  - Fort Myers, Florida, Forenede Stater, 33901
    - Associates in Research
  - Ft. Lauderdale, Florida, Forenede Stater, 33311
    - Comprehensive Care Center
  - Ft. Lauderdale,, Florida, Forenede Stater, 33316
    - Gary J. Richmond, MD
  - Plantation, Florida, Forenede Stater, 33317
    - Morris, Sklaver, Mestre & Denney, M.D., PA
  - Safety Harbor, Florida, Forenede Stater, 34695
    - Health Positive
  - Tampa, Florida, Forenede Stater, 33614
    - Infectious Disease Research Institute, Inc.
  - Vero Beach, Florida, Forenede Stater, 32960
    - Treasure Coast Infectious Disease Consultants
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30308
    - AIDS Research Consortium of Atlanta Inc.
- Kansas
  - Wichita,, Kansas, Forenede Stater, 67214
    - Donna E. Sweet, MD
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70115
    - Drs. Combs and Lutz
- New Jersey
  - Newark, New Jersey, Forenede Stater, 07102-9880
    - St. Michael's Medical Center
- New York
  - New York, New York, Forenede Stater, 10011
    - Polari Medical Group
- North Carolina
  - Winston-Salem,, North Carolina, Forenede Stater, 27157-1042
    - Wake Forest University School of Medicine
- Ohio
  - Akron, Ohio, Forenede Stater, 44304
    - Akron Infectious Disease, Inc.
- Oklahoma
  - Tulsa, Oklahoma, Forenede Stater, 74114
    - Associates in Medical and Mental Health, P.C.
- Oregon
  - Portland, Oregon, Forenede Stater, 97209-2535
    - The Research & Education Group
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19107
    - Triangle Medical
  - Philadelphia,, Pennsylvania, Forenede Stater, 19107
    - Philadelphia FIGHT
- Texas
  - Austin, Texas, Forenede Stater, 78705
    - Central Texas Clinical Research
  - Houston, Texas, Forenede Stater, 77004
    - Joseph C. Gathe, Jr, MD
  - Houston, Texas, Forenede Stater, 77098
    - Southampton Medical Group
- Virginia
  - Hampton, Virginia, Forenede Stater, 23666
    - Hampton Roads Medical Specialists
Frankrig
- - Le Kremlin Bicetre, Frankrig, 94272
    - CHU Kremlin Bicetre
  - Nice, Frankrig, 06202
    - Hôpital l'Archet
  - Paris, Frankrig, 75018
    - Hôpital Bichat
- Cedex 10
  - Paris, Cedex 10, Frankrig, 75475
    - Hopital Saint Louis
- Cedex 12
  - Paris, Cedex 12, Frankrig, 75571
    - Hôpital Saint Antoine
- Cedex 20
  - Paris, Cedex 20, Frankrig, 75970
    - Hôpital Tenon
Singapore
- - Tan Tock Seng, Singapore, 308433
    - Tan Tock Seng Hospital
Spanien
- - Badalona, Spanien, 08916
    - Hospital Germans Trias i Pujol
  - Barcelona, Spanien, 08035
    - Hospital Vall d'Hebron
  - Barcelona, Spanien, 08025
    - Hospital de la Santa Creu i Sant Pau
  - Barcelona, Spanien, 08907
    - L'Hospitalet de Llobregat
  - Madrid, Spanien, 28046
    - Hospital La Paz
  - Madrid, Spanien, 28041
    - Hospital 12 de Octubre
  - Madrid, Spanien, 28935
    - Hospital de Mostolesi
Tyskland
- - Frankfurt, Tyskland, D-60590
    - Klinikum J.W. Goethe Universitat
  - Koln, Tyskland, D-505924
    - Klinik I fur Innere Medizin der Universitat zu Koln

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 at least 18 years of age.
If female, subject is 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) *contraceptives (oral or parenteral) for three months prior to study drug administration) *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) and a urine pregnancy test performed on Study Day -1 are both negative and the subject agrees to use a barrier method of contraception throughout the study.
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 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, herbal medications, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
Subject has a Karnofsky Score greater than or equal to 70
Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Abbott.
Subject is naive to antiretroviral treatment (< 7 days ARV treatment).
Subject has a plasma HIV RNA level of greater than 1,000 copies/mL at screening.
Subject agrees to take all doses of the lopinavir/ritonavir from the bottles provided by the sponsor (rather than take doses from a personal "dosette" 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 lopinavir/ritonavir, tenofovir or emtricitabine or to drugs similar to study drug.
Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse.
Subject has a positive result on the screening tests for drugs of abuse.
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 ≤ 8.0 g/dL *Absolute neutrophil count ≤ 750 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
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott

Efterforskere

Studieleder: Scott Brun, M.D., Global Project Head, Antiviral Global Project Team

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Podsadecki TJ, Vrijens BC, Tousset EP, Rode RA, Hanna GJ. Decreased adherence to antiretroviral therapy observed prior to transient human immunodeficiency virus type 1 viremia. J Infect Dis. 2007 Dec 15;196(12):1773-8. doi: 10.1086/523704.

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. juli 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. juli 2006

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juli 2006

Sidst verificeret

1. juli 2006

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

behandling naiv

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

M02-418

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 .