Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
2017년 9월 13일 업데이트: University of North Carolina, Chapel Hill
Prospective Study of Pharmacokinetics, Clinical and Virologic Response to Acyclovir Episodic Therapy for Genital Herpes Ulcers in HIV Negative African Women
This is a prospective study to evaluate the pharmacokinetics, clinical and virologic response to acyclovir episodic therapy for genital herpes ulcers in HIV negative African women.
연구 개요
상세 설명
This is a two-part study designed to measure the Area Under the Curve (AUC) from a single dose of acyclovir 400mg in 60 African HIV-negative heterosexual women who have a history of genital ulcer disease (GUD), are HSV-2 seropositive and HIV-1 seronegative.
The study will also examine the time to healing of genital lesion and duration of HSV shedding from GUD among 90 HIV negative African women who have a history of GUD and are Herpes Simplex Virus (HSV)-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir or matching placebo.
연구 유형
중재적
등록 (실제)
74
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Lusaka, 잠비아
- Centre for Infectious Disease Research in Zambia
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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 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- HIV negative as determined by concordant rapid testing
- HSV-2 seropositive (Focus HerpeSelect EIA >3.4)
- At least one prior occurrence of GUD
- 18 to 50 years of age
Exclusion Criteria:
- Current use, or use within the past 7 days, of acyclovir, valacyclovir, or famciclovir
- Prior hypersensitivity and/or allergic reaction to acyclovir
- Use of probenecid, which prolongs renal excretion of acyclovir
- Current use, or use within the past 28 days, of an investigational agent
- Currently pregnant or nursing
- Currently plan to become pregnant during the next 3 months
- Currently consume, on average, more than 7 drinks of alcohol per week (for Part I)
- Current use of more than 20 cigarettes daily (for Part I)
- Any condition that in the opinion of the investigator will interfere with successful completion of all study procedures.
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: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Part 1 PK
400mg dose of acyclovir taken orally, followed by 2 ml blood plasma collection at 1,2,4,6 and 8 hours.
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Single dose of acyclovir 200mg was given for pk study
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활성 비교기: Acyclovir
400 mg Acyclovir three times daily for 5 days
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Single dose of acyclovir 200mg was given for pk study
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위약 비교기: Placebo
Placebo three times daily for 5 days
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Area under the Curve (AUC)
기간: 0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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Blood will be drawn for pharmacokinetic measures to determine whether there is a difference in African women vs. the existing AUC data for women and men in North America and Europe.
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0, 2, 3, 4, 6 and 8 hours post acyclovir administration
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to re-epithelization and time to cessation of HSV shedding
기간: days 1-5, 7, 9, 11 and 13
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Daily assessment of response of genital lesions over 13 days by time to healing and duration of HSV shedding during acyclovir 400mg orally three times daily versus placebo three times daily for 5 days.
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days 1-5, 7, 9, 11 and 13
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Stewart Reid, MD, Centre for Infectious Disease Research in Zambia
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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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
2009년 1월 1일
기본 완료 (실제)
2009년 12월 1일
연구 완료 (실제)
2009년 12월 1일
연구 등록 날짜
최초 제출
2014년 1월 31일
QC 기준을 충족하는 최초 제출
2014년 1월 31일
처음 게시됨 (추정)
2014년 2월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 9월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 9월 13일
마지막으로 확인됨
2014년 12월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CIDRZ 1208/IRB12-0390
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. .
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