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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
73
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Carmichael, California, Forenede Stater, 95608
- GSK Investigational Site
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Davis, California, Forenede Stater, 95616
- GSK Investigational Site
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Riverside, California, Forenede Stater, 92506
- GSK Investigational Site
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Sacramento, California, Forenede Stater, 92585
- GSK Investigational Site
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
- GSK Investigational Site
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Indianapolis, Indiana, Forenede Stater, 46202
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- GSK Investigational Site
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New York
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New York, New York, Forenede Stater, 10029
- GSK Investigational Site
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New York, New York, Forenede Stater, 10011
- GSK Investigational Site
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Stony Brook, New York, Forenede Stater, 11794
- GSK Investigational Site
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The Bronx, New York, Forenede Stater, 10461
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- GSK Investigational Site
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Oklahoma
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Tulsa, Oklahoma, Forenede Stater, 74104
- GSK Investigational Site
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Oregon
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Portland, Oregon, Forenede Stater, 97210
- GSK Investigational Site
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Texas
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Houston, Texas, Forenede Stater, 77030
- GSK Investigational Site
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
- GSK Investigational Site
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Washington
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Seattle, Washington, Forenede Stater, 98104
- GSK Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Sequence 1: VALTREX 1 g once daily, Placebo
VALTREX 1 g once daily, Placebo
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placebo
Valtrex 1g once daily
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Eksperimentel: Sequence 2: Placebo, VALTREX 1 g once daily
Placebo, VALTREX 1 g once daily
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placebo
Valtrex 1g once daily
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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.
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Up to Day 60 of each treatment period (up to 160 days)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
29. marts 2005
Primær færdiggørelse (Faktiske)
10. januar 2006
Studieafslutning (Faktiske)
10. januar 2006
Datoer for studieregistrering
Først indsendt
30. juni 2005
Først indsendt, der opfyldte QC-kriterier
30. juni 2005
Først opslået (Skøn)
1. juli 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VLX103596
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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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Datasætspecifikation
Informations-id: VLX103596Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokol
Informations-id: VLX103596Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Annoteret sagsbetænkningsformular
Informations-id: VLX103596Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: VLX103596Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analyseplan
Informations-id: VLX103596Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinisk undersøgelsesrapport
Informations-id: VLX103596Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Formular til informeret samtykke
Informations-id: VLX103596Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .