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VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.

2 augusti 2017 uppdaterad av: GlaxoSmithKline

Valacyclovir for the Suppression of HSV-2 Viral Shedding in HSV-2 Seropositive Individuals With No History of Symptomatic GH

Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

73

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Carmichael, California, Förenta staterna, 95608
        • GSK Investigational Site
      • Davis, California, Förenta staterna, 95616
        • GSK Investigational Site
      • Riverside, California, Förenta staterna, 92506
        • GSK Investigational Site
      • Sacramento, California, Förenta staterna, 92585
        • GSK Investigational Site
    • Indiana
      • Fort Wayne, Indiana, Förenta staterna, 46804
        • GSK Investigational Site
      • Indianapolis, Indiana, Förenta staterna, 46202
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02115
        • GSK Investigational Site
    • New York
      • New York, New York, Förenta staterna, 10029
        • GSK Investigational Site
      • New York, New York, Förenta staterna, 10011
        • GSK Investigational Site
      • Stony Brook, New York, Förenta staterna, 11794
        • GSK Investigational Site
      • The Bronx, New York, Förenta staterna, 10461
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • GSK Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, Förenta staterna, 74104
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, Förenta staterna, 97210
        • GSK Investigational Site
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84132
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • GSK Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • In overall general good health.
  • HSV-2 (Herpes Simplex Virus-2) seropositive at screening.

Exclusion criteria:

  • have active lesions consistent with genital herpes.
  • previous history of symptomatic genital herpes.
  • history of recurrent, undiagnosed symptoms consistent with genital herpes.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Sequence 1: VALTREX 1 g once daily, Placebo
VALTREX 1 g once daily, Placebo
Läkemedel: Placebo
placebo
Läkemedel: Valaciclovir
Valtrex 1g once daily
Experimentell: Sequence 2: Placebo, VALTREX 1 g once daily
Placebo, VALTREX 1 g once daily
Läkemedel: Placebo
placebo
Läkemedel: Valaciclovir
Valtrex 1g once daily

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
Tidsram: Up to Day 60 of each treatment period (up to 160 days)
Percent of subclinical days with HSV-2 shedding was defined for each participant as the percent of subclinical days with PCR data for which HSV-2 shedding was detected by a positive PCR result, that is, the number of subclinical days with HSV-2 PCR shedding divided by total number of subclinical days with PCR data, multiplied by 100. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or subclinical (no genital lesions). Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
Up to Day 60 of each treatment period (up to 160 days)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean Percent Days of Total HSV-2 Shedding
Tidsram: Up to Day 60 of each treatment period (up to 160 days)
The percent of days with total (clinical and subclinical) HSV-2 shedding was defined as the percent of all days with PCR data for which HSV-2 shedding was detected. Mean percent of days with total HSV-2 shedding was the statistic used to summarize this endpoint for each treatment group. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions). The total shedding rate was defined for each participant as the percentage of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Genital/anal-rectal swabs was collected daily during each entire 60-day treatment period of each period and the washout period.
Up to Day 60 of each treatment period (up to 160 days)
Number of Participants With no Shedding
Tidsram: Up to Day 60 of each treatment period (up to 160 days)
The number of participants with no shedding was defined as the number of participants with no HSV-2 shedding detected by PCR divided by the total number of participants with PCR data. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Up to Day 60 of each treatment period (up to 160 days)
Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding
Tidsram: Up to Day 60 of each treatment period (up to 160 days)
The subclinical shedding rate was defined for each participant as the total number of subclinical days on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with subclinical shedding was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all subclinical shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Up to Day 60 of each treatment period (up to 160 days)
Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding
Tidsram: Up to Day 60 of each treatment period (up to 160 days)
The total shedding rate was defined for each participant as the total number of all days (clinical and subclinical) on treatment during which shedding was detected by PCR. Average log HSV-2 DNA copy number per day on days with total shedding (clinical and subclinical) was defined as the daily maximum HSV-2 DNA copy number was log transformed and averaged over all shedding days. During each 60-day treatment period and during washout, swabs were collected daily from the genital/anal-rectal area for HSV-2 detection by PCR. During an outbreak, lesion swabs were also collected for HSV-2 detection by PCR. For each participant, each study day was classified by PCR as 'shedding' or 'no shedding'; additionally each day was classified as 'clinical' (presence of genital lesions) or 'subclinical" (no genital lesions).
Up to Day 60 of each treatment period (up to 160 days)
Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study
Tidsram: Up to Day 60 of each treatment period (up to 160 days)
Participants who have recognized clinical signs/symptoms of genital herpes infection during the study. Participants were educated on recognizing signs and symptoms of genital herpes infection at the screening/randomization visit. Genital examinations was conducted at the randomization and genital herpes outbreak visits.
Up to Day 60 of each treatment period (up to 160 days)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 mars 2005

Primärt slutförande (Faktisk)

10 januari 2006

Avslutad studie (Faktisk)

10 januari 2006

Studieregistreringsdatum

Först inskickad

30 juni 2005

Först inskickad som uppfyllde QC-kriterierna

30 juni 2005

Första postat (Uppskatta)

1 juli 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • VLX103596

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokument

  1. Datauppsättningsspecifikation
    Informationsidentifierare: VLX103596
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Studieprotokoll
    Informationsidentifierare: VLX103596
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annoterad fallrapportformulär
    Informationsidentifierare: VLX103596
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datauppsättning för individuella deltagare
    Informationsidentifierare: VLX103596
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistisk analysplan
    Informationsidentifierare: VLX103596
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Klinisk studierapport
    Informationsidentifierare: VLX103596
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informerat samtycke
    Informationsidentifierare: VLX103596
    Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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