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

The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs

23. juni 2005 opdateret af: Boehringer Ingelheim

An International, Double Blind, Randomized, Phase III Study to Evaluate the Tolerance, Safety, and Effectiveness of Viramune (Nevirapine) in Preventing Clinical AIDS Progression Events or Death When Used in Combination With Lamivudine (3TC) and Stable (>= 4 Weeks) Background Nucleoside Therapy

To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.

Undersøgelsestype

Interventionel

Tilmelding

2000

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Montgomery, Alabama, Forenede Stater, 36104
        • Drug Research and Analysis Corp
    • California
      • Los Angeles, California, Forenede Stater, 90067
        • Dr G Michael Wool
      • Los Angeles, California, Forenede Stater, 900951793
        • UCLA School of Medicine / Ctr for Research and Education
      • Palo Alto, California, Forenede Stater, 94304
        • AIDS Research Ctr / Palo Alto VA Health Care System
      • Redwood City, California, Forenede Stater, 94063
        • AIDS Community Research Consortium
      • San Francisco, California, Forenede Stater, 94109
        • ViRx Inc
      • San Francisco, California, Forenede Stater, 94110
        • San Francisco Gen Hosp / UCSF AIDS Program
      • Torrance, California, Forenede Stater, 90502
        • Harbor - UCLA Med Ctr
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80903
        • Infectious Disease Specialists
      • Denver, Colorado, Forenede Stater, 80204
        • Denver Public Health
      • Denver, Colorado, Forenede Stater, 80205
        • Dr Miguel Mogyoros / Clinical Research Dept
    • Delaware
      • Wilmington, Delaware, Forenede Stater, 19801
        • Wilmington Hosp
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20037
        • Novum Inc
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • North Broward Hosp District
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Anthony LaMarca
      • Fort Myers, Florida, Forenede Stater, 33901
        • Dr Robert Schwartz
      • Fort Myers, Florida, Forenede Stater, 33901
        • McGregor Clinic / Lee County Public Health Unit
      • Jacksonville, Florida, Forenede Stater, 32216
        • P Andrew Coley
      • Maitland, Florida, Forenede Stater, 32751
        • Goodgame Med Group
      • Tampa, Florida, Forenede Stater, 33614
        • Infectious Disease Research Institute Inc
      • West Palm Beach, Florida, Forenede Stater, 33409
        • Palm Beach Research Ctr
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60610
        • Dr John Pottage
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Univ / Division of Infectious Diseases
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana Univ Med School
    • Iowa
      • Des Moines, Iowa, Forenede Stater, 50325
        • Dr Daniel H Gervich
      • Iowa City, Iowa, Forenede Stater, 52242
        • Univ of Iowa
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40563
        • Univ of Kentucky Med Cntr / Dept of Med / Div of ID
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Med Research Ctr
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • New England Med Ctr
      • Boston, Massachusetts, Forenede Stater, 02215
        • New England Deaconess Hosp
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Hosp / Virology Research Clinic
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • International Medicine and Infectious Disease
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108
        • Trinity Lutheran Hosp / HIV Program
    • New Jersey
      • Somerville, New Jersey, Forenede Stater, 08876
        • Infectious Disease Associates of Central New Jersey
    • New York
      • Buffalo, New York, Forenede Stater, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • New York, New York, Forenede Stater, 10014
        • Dr David Kaufman
      • Staten Island, New York, Forenede Stater, 10310
        • Saint Vincent Med Ctr
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74114
        • Associates in Med and Mental Health
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • The Research and Education Group
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Hershey Med Ctr / Dept of Med / Div of Hematology
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Univ of Pennsylvania / Division of Infectious Diseases
      • Pittsburgh, Pennsylvania, Forenede Stater, 152063817
        • Novum Inc
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02907
        • Omega Med Research
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Med Univ of South Carolina / Div of Infect Dis
      • Columbia, South Carolina, Forenede Stater, 29206
        • Dr Alfred Burnside
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38163
        • Dr Susie Sargent
    • Texas
      • Dallas, Texas, Forenede Stater, 75219
        • Nelson Tebedo Health Resource Ctr
      • Galveston, Texas, Forenede Stater, 775550835
        • Univ of Texas Med Branch / Div of Infectious Dis
      • Houston, Texas, Forenede Stater, 77006
        • Houston Clinical Research Network / Div of Montrose Clinic
      • Irving, Texas, Forenede Stater, 75038
        • Walter Gaman
    • Virginia
      • Hampton, Virginia, Forenede Stater, 23666
        • Hampton Roads Med Specialists
    • Washington
      • Seattle, Washington, Forenede Stater, 981225314
        • Advanced Research Management

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

13 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4+ cell count <= 200 cells/mm3.
  • Life expectancy > 3 months.
  • Written informed consent from parent or guardian for patients < 18 years of age.
  • Willingness and ability to follow protocol requirements.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions or symptoms are excluded:

Patient is enrolled or plans to enroll during the course of this study in another clinical study of an antiretroviral or other agent used to treat HIV-1 infection.

  • NOTE:
  • Patients are allowed to participate in opportunistic infection clinical studies if the investigational agent is not contraindicated for the study.

Concurrent Medication:

Excluded:

  • Patient is receiving therapy with an antiretroviral agent other than ZDV, d4T, ddI, ddC, or 3TC.
  • Patient is receiving acute therapy for a clinical AIDS progression event such as systemic chemotherapy.
  • Dicumarol, Warfarin and other anticoagulant medications.
  • Tolbutamide.
  • Investigational drugs (unless included in opportunistic infection clinical trial) and all antiretroviral agents (excluding ZDV, ddC, ddI, d4T and 3TC).
  • Neurotoxic drugs.
  • Cimetidine.
  • Erythromycin.

Concurrent Treatment:

Excluded:

Radiation therapy.

Patients with any of the following prior conditions and symptoms are excluded:

History of clinically important disease other than HIV-1 infection or related diseases that, in the opinion of the investigator, may put the patient at risk because of participation in this study.

Prior Medication:

Excluded:

  • Patient has received prior therapy with Viramune or any other non-nucleoside reverse transcriptase inhibitor.
  • Patient has received any immunosuppressive or cytotoxic drugs or any other experimental agent within 4 weeks prior to study day 1.
  • Patient has received treatment with erythromycin, coumadin/warfarin, phenobarbital, amoxicillin/clavulanic acid, or ticarcillin/clavulanic acid within 2 weeks prior to study day 0.

Risk Behavior:

Excluded:

Patients who are active chronic alcohol or substance abusers or have an active psychiatric condition sufficient to impair compliance with protocol requirements.

Required:

Patient must be receiving stable nucleoside therapy with at least one agent for >= 4 weeks prior to study day 0. Zidovudine (ZDV), Zidovudine + Dideoxycytidine (ddC), or Zidovudine + Didanosine (ddI) must be used unless prior intolerance precludes ZDV use. Stable use means no change in dose > 50% for any background nucleoside within four weeks prior to study day 0.

NOTE:

  • If patient is ZDV intolerant, ddC, ddI or D4T monotherapy is allowed.

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
  • Interventionel model: Parallel tildeling

Samarbejdspartnere og efterforskere

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

Sponsor

Boehringer Ingelheim

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.

Datoer for studieregistrering

Først indsendt

2. november 1999

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. juni 2005

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2005

Sidst verificeret

1. august 2002

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 200E
  • 1100.1090

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 .

Abonner