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

23. juni 2005 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering

2000

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Intervensjonsmodell: Parallell tildeling

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Datoer for studieregistrering

Først innsendt

2. november 1999

Først innsendt som oppfylte QC-kriteriene

30. august 2001

Først lagt ut (Anslag)

31. august 2001

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. juni 2005

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2005

Sist bekreftet

1. august 2002

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 200E
  • 1100.1090

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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