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A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients

23. juni 2005 oppdatert av: Glaxo Wellcome

An International, Randomized, Double-Blind, Placebo-Controlled Study of Valacyclovir for the Suppression of Recurrent Ano-Genital HSV Infections in HIV-Infected Subjects

The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients are randomized in a 2:1 ratio to receive either Valtrex or placebo, twice daily, for up to 6 months. Patients come to the clinic for routine monthly assessments for 6 months, and return to the clinic for evaluation within 24 hours of the first signs or symptoms of an ano-genital HSV recurrence. Once the clinician confirms the presence of at least the macular/papular lesion stage, double-blind suppressive therapy is discontinued and open-label treatment with a higher dose of Valtrex twice daily for 5 days is initiated. For the first recurrence, patients are instructed to return to the clinic for further clinical assessments on Day 5 of the recurrence. Patients who have not healed by Day 5 may be offered an additional five days of open-label treatment, as deemed appropriate by the clinical investigator. If an additional 5-day course of open-label treatment medication is dispensed, the patient returns to the clinic on Day 10 for evaluation. Patients who have not healed by Day 10 are managed as deemed appropriate by the investigator. Once treatment of the first ano-genital HSV recurrence is complete and the patient is healed, patients are switched to open-label suppressive therapy with Valtrex for the remainder of the study period (up to a maximum of 6 months). The total duration of the study for all patients is 6 months.

Studietype

Intervensjonell

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Dr Barbara Romanowski
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Ctr
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique Medicale L'Actuele
      • Ste Foy, Quebec, Canada
        • Centre De Recherche En Infectiologie
  • Forente stater
    • California
      • Berkeley, California, Forente stater, 94705
        • East Bay AIDS Ctr
      • Beverly Hills, California, Forente stater, 90211
        • Pacific Oaks Research
      • Los Angeles, California, Forente stater, 90036
        • Kraus Med Partners
      • San Francisco, California, Forente stater, 94109
        • ViRx Inc
    • Florida
      • Altamonte Springs, Florida, Forente stater, 32701
        • IDC Research Initiative
      • Fort Lauderdale, Florida, Forente stater, 33316
        • Healthnet Institute
      • Miami, Florida, Forente stater, 331361013
        • Univ of Miami School of Medicine
      • Vero Beach, Florida, Forente stater, 32960
        • Treasure Coast Infectious Disease Consultants
      • West Palm Beach, Florida, Forente stater, 33409
        • Palm Beach Research Ctr
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana Univ School of Medicine / Dept of Infect Dis
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55455
        • Univ of Minnesota
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Advanced Biomedical Research Inc
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28207
        • Nalle Clinic / Clinical Research Dept
      • Raleigh, North Carolina, Forente stater, 27610
        • Wake County Dept of Health
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • Westover Heights Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Philadelphia FIGHT
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02907
        • Dr Alvan Fisher
    • Texas
      • Houston, Texas, Forente stater, 770303498
        • Baylor College of Medicine / Dept of Medicine
    • Virginia
      • Richmond, Virginia, Forente stater, 23219
        • Richmond AIDS Consortium
    • Washington
      • Seattle, Washington, Forente stater, 98122
        • Univ of Washington Virology Research Clinic

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 18 years old.
  • Are HIV-positive.
  • Have herpes simplex virus (HSV) 2.
  • Have received combination anti-HIV therapy for at least 2 months before entering the study.
  • Have had 4 or more recurrences of ano-genital HSV (herpes infection of the anus and genitals) in the last 12 months. (If patient is taking medication to control HSV, then he/she must have had 4 or more recurrences of ano-genital HSV per year before beginning regular anti-HSV therapy, which is defined as therapy of 12 or more weeks.)
  • Agree to use effective methods of birth control from 2 weeks before taking study drug, throughout the study, and for 4 weeks after completing the study. (A female may be eligible if not able to have children.)

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have blood vessel disease.
  • Are sensitive to acyclovir, Valtrex, famciclovir, or ganciclovir.
  • Are unable to take medications by mouth.
  • Have non-healed sores on the anus or genitals at beginning of study.
  • Are using anti-herpes drugs. To be eligible for enrollment, patients currently using anti-herpes drugs must stop treatment with these drugs at the beginning of the study; however, therapy may be started again if the investigator finds it necessary.
  • Are using interferon. Patients receiving interferon must stop interferon before beginning the study.
  • Have kidney or liver problems.
  • Are pregnant or breast-feeding.
  • Have a type of HSV that is resistant to acyclovir, Valtrex, famciclovir, or ganciclovir.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Masking: Dobbelt

Samarbeidspartnere og etterforskere

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

Sponsor

Glaxo Wellcome

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.

Studer hoveddatoer

Studiestart

1. juni 1999

Datoer for studieregistrering

Først innsendt

11. mai 2000

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. juli 2001

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 104C
  • HS230018

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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Forhold

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