- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00845676
Treatment of Acute Hepatitis C Virus in HIV Co-Infection
연구 개요
상세 설명
Hepatitis C virus (HCV) infection is one of the most important causes of illness and death among people living with HIV/AIDS. Over 200,000 people in the Unites States, including 37,000 in California, are co-infected with HIV and HCV. In the past, people who had both HIV and HCV often died from AIDS before HCV could cause serious problems. However, with improvements in HIV/AIDS care and treatment, more co-infected people are living longer and thus developing complications from their HCV, including liver scarring (called cirrhosis) and death. HCV infection can also make HIV medications more toxic to the liver, limiting HIV treatment options. Treatment for chronic (or long-term) HCV infection has improved in recent years, but people with HIV are still about half as likely to clear their chronic HCV infection with treatment as HIV-negative individuals. Also, HCV treatment can be very toxic and may have serious side effects for patients, particularly those with HIV.
Recent research suggests that treatment started within the first few months after getting HCV infection (called "acute infection") can result in high treatment response rates for people who do not have HIV. It is not known whether similarly high treatment response rates can also be seen in people with HIV. It has also been shown that each individual's response to the early phases of HCV treatment can predict his or her ability to clear HCV infection after the end of treatment. This study will look at whether it is possible to follow each person's own HCV viral load over time as a measure of treatment success and to tailor each individual's treatment to his or her own response. This idea is called "kinetically guided therapy" and is a new way of individualizing treatment regimen to produce high treatment success rates while minimizing the amount of potentially toxic medications that an individual might not need.
In this pilot study, 20 HIV-infected individuals with acute HCV infection will be treated with HCV therapy for 24 weeks. Because HIV co-infection decreases treatment success in chronic HCV infection, treatment will be started with the strong combination of pegylated-interferon plus ribavirin. However, this protocol will monitor each individual's HCV viral load during the first 12 weeks of treatment and will stop the ribavirin at week 12 if the individual has a good early response and might not need to continue both medications. Using this approach, pegylated interferon will be given for the full 24 weeks of treatment, but ribavirin will be continued for either 12 or 24 weeks, depending on each individual's early response to therapy. The primary endpoint for this study is the percentage of people who have a sustained virologic response to the study treatment. The side effects of treatment will also be measured in order to determine the overall risks and benefits of this approach to treatment.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
-
California
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San Francisco, California, 미국, 94110
- San Francisco General Hospital/UCSF
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Newly acquired HCV infection of 6 months or less duration
- Detectable HCV RNA at study entry
- HIV infection, any CD4 count
Exclusion Criteria:
- Pregnant or intent to become pregnant within 24 weeks of study completion
- Uncontrolled depression
- Other serious liver disease
- Other safety parameters must be met
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Pegylated interferon alfa-2a + Ribavirin
|
Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Sustained Virologic Response (SVR)
기간: 24 weeks
|
Proportion of subjects achieving a sustained virologic response (SVR), defined as undetectable HCV RNA 24-weeks after completion of treatment
|
24 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Safety and Tolerability of Treatment
기간: 48 weeks
|
Number of participants with treatment-associated problems
|
48 weeks
|
Association of SVR With Entry HCV RNA, Entry ALT, Entry CD4, and IL28B Genotype
기간: 24 weeks
|
Predictors of SVR, including early HCV RNA response to treatment as they relate to SVR
|
24 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Brad Hare, MD, University of California, San Francisco
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 소화기계 질환
- 병리학적 과정
- RNA 바이러스 감염
- 바이러스 질환
- 혈액 매개 감염
- 성병, 바이러스성
- 성병
- 렌티바이러스 감염
- 레트로바이러스과 감염
- 면역 결핍 증후군
- 면역계 질환
- 질병 속성
- 간 질환
- 플라비바이러스과 감염
- 간염, 바이러스, 인간
- 엔테로바이러스 감염
- 피코르나바이러스과 감염
- 느린 바이러스 질환
- HIV 감염
- 감염
- 전염병
- 간염
- A형 간염
- C 형 간염
- 후천성면역결핍증후군
- 동시 감염
- 약물의 생리적 효과
- 약리작용의 분자기전
- 항감염제
- 항바이러스제
- 항대사물질
- 항종양제
- 면역학적 요인
- 인터페론
- 인터페론-알파
- 리바비린
- 페그인터페론 알파-2a
- 인터페론 알파-2
기타 연구 ID 번호
- CHRP ID06-SF-218
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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