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.
2017년 8월 2일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
73
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Carmichael, California, 미국, 95608
- GSK Investigational Site
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Davis, California, 미국, 95616
- GSK Investigational Site
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Riverside, California, 미국, 92506
- GSK Investigational Site
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Sacramento, California, 미국, 92585
- GSK Investigational Site
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Indiana
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Fort Wayne, Indiana, 미국, 46804
- GSK Investigational Site
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Indianapolis, Indiana, 미국, 46202
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- GSK Investigational Site
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New York
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New York, New York, 미국, 10029
- GSK Investigational Site
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New York, New York, 미국, 10011
- GSK Investigational Site
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Stony Brook, New York, 미국, 11794
- GSK Investigational Site
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The Bronx, New York, 미국, 10461
- GSK Investigational Site
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- GSK Investigational Site
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Oklahoma
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Tulsa, Oklahoma, 미국, 74104
- GSK Investigational Site
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Oregon
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Portland, Oregon, 미국, 97210
- GSK Investigational Site
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Texas
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Houston, Texas, 미국, 77030
- GSK Investigational Site
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Utah
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Salt Lake City, Utah, 미국, 84132
- GSK Investigational Site
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Washington
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Seattle, Washington, 미국, 98104
- GSK Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Sequence 1: VALTREX 1 g once daily, Placebo
VALTREX 1 g once daily, Placebo
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위약
Valtrex 1g once daily
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실험적: Sequence 2: Placebo, VALTREX 1 g once daily
Placebo, VALTREX 1 g once daily
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위약
Valtrex 1g once daily
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Percent Days of Subclinical Shedding as Determined by Type-specific Polymerase Chain Reaction (PCR) Assay for HSV-2
기간: Up to Day 60 of each treatment period (up to 160 days)
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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.
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Up to Day 60 of each treatment period (up to 160 days)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Percent Days of Total HSV-2 Shedding
기간: Up to Day 60 of each treatment period (up to 160 days)
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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.
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Up to Day 60 of each treatment period (up to 160 days)
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Number of Participants With no Shedding
기간: Up to Day 60 of each treatment period (up to 160 days)
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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).
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Up to Day 60 of each treatment period (up to 160 days)
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Mean Log HSV-2 DNA Copy Number Per Day on Days With Subclinical Shedding
기간: Up to Day 60 of each treatment period (up to 160 days)
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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)
|
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Mean Log HSV-2 DNA Copy Number Per Day on Days With Total Shedding
기간: Up to Day 60 of each treatment period (up to 160 days)
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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).
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Up to Day 60 of each treatment period (up to 160 days)
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Percent Overall Study Population Who Have Recognized Clinical Signs/Symptoms of Genital Herpes Infection During the Study
기간: Up to Day 60 of each treatment period (up to 160 days)
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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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2005년 3월 29일
기본 완료 (실제)
2006년 1월 10일
연구 완료 (실제)
2006년 1월 10일
연구 등록 날짜
최초 제출
2005년 6월 30일
QC 기준을 충족하는 최초 제출
2005년 6월 30일
처음 게시됨 (추정)
2005년 7월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 2월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 8월 2일
마지막으로 확인됨
2017년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VLX103596
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
연구 데이터/문서
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데이터 세트 사양
정보 식별자: VLX103596정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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연구 프로토콜
정보 식별자: VLX103596정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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주석이 달린 사례 보고서 양식
정보 식별자: VLX103596정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
개별 참가자 데이터 세트
정보 식별자: VLX103596정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: VLX103596정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: VLX103596정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: VLX103596정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .