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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 agosto 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

73

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sequence 1: VALTREX 1 g once daily, Placebo
VALTREX 1 g once daily, Placebo
Droga: Placebo
placebo
Droga: Valaciclovir
Valtrex 1g once daily
Sperimentale: Sequence 2: Placebo, VALTREX 1 g once daily
Placebo, VALTREX 1 g once daily
Droga: Placebo
placebo
Droga: Valaciclovir
Valtrex 1g once daily

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Percent Days of Total HSV-2 Shedding
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 marzo 2005

Completamento primario (Effettivo)

10 gennaio 2006

Completamento dello studio (Effettivo)

10 gennaio 2006

Date di iscrizione allo studio

Primo inviato

30 giugno 2005

Primo inviato che soddisfa i criteri di controllo qualità

30 giugno 2005

Primo Inserito (Stima)

1 luglio 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 febbraio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 agosto 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • VLX103596

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Dati/documenti di studio

  1. Specifica del set di dati
    Identificatore informazioni: VLX103596
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Protocollo di studio
    Identificatore informazioni: VLX103596
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Modulo di segnalazione del caso annotato
    Identificatore informazioni: VLX103596
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Set di dati del singolo partecipante
    Identificatore informazioni: VLX103596
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Piano di analisi statistica
    Identificatore informazioni: VLX103596
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Rapporto di studio clinico
    Identificatore informazioni: VLX103596
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Modulo di consenso informato
    Identificatore informazioni: VLX103596
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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