- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00116844
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. august 2017 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
73
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Carmichael, California, Forente stater, 95608
- GSK Investigational Site
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Davis, California, Forente stater, 95616
- GSK Investigational Site
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Riverside, California, Forente stater, 92506
- GSK Investigational Site
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Sacramento, California, Forente stater, 92585
- GSK Investigational Site
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Indiana
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Fort Wayne, Indiana, Forente stater, 46804
- GSK Investigational Site
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Indianapolis, Indiana, Forente stater, 46202
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- GSK Investigational Site
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New York
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New York, New York, Forente stater, 10029
- GSK Investigational Site
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New York, New York, Forente stater, 10011
- GSK Investigational Site
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Stony Brook, New York, Forente stater, 11794
- GSK Investigational Site
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The Bronx, New York, Forente stater, 10461
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- GSK Investigational Site
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74104
- GSK Investigational Site
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Oregon
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Portland, Oregon, Forente stater, 97210
- GSK Investigational Site
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Texas
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Houston, Texas, Forente stater, 77030
- GSK Investigational Site
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- GSK Investigational Site
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Washington
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Seattle, Washington, Forente stater, 98104
- GSK Investigational Site
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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
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Sequence 1: VALTREX 1 g once daily, Placebo
VALTREX 1 g once daily, Placebo
|
placebo
Valtrex 1g once daily
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Eksperimentell: Sequence 2: Placebo, VALTREX 1 g once daily
Placebo, VALTREX 1 g once daily
|
placebo
Valtrex 1g once daily
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mean Percent Days of Total HSV-2 Shedding
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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 (Faktiske)
29. mars 2005
Primær fullføring (Faktiske)
10. januar 2006
Studiet fullført (Faktiske)
10. januar 2006
Datoer for studieregistrering
Først innsendt
30. juni 2005
Først innsendt som oppfylte QC-kriteriene
30. juni 2005
Først lagt ut (Anslag)
1. juli 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. februar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2017
Sist bekreftet
1. august 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VLX103596
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
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Datasettspesifikasjon
Informasjonsidentifikator: VLX103596Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: VLX103596Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annotert saksrapportskjema
Informasjonsidentifikator: VLX103596Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datasett for individuell deltaker
Informasjonsidentifikator: VLX103596Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analyseplan
Informasjonsidentifikator: VLX103596Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk studierapport
Informasjonsidentifikator: VLX103596Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Skjema for informert samtykke
Informasjonsidentifikator: VLX103596Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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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