Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4
Open, Randomized, Multicenter Phase IV Study to Evaluate Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Patients Genotype 1 and/or 4
A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients.
The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment.
In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%.
The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment.
Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Barcelona, 스페인, 08025
- Hospital Santa Creu i Sant Pau
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Cádiz, 스페인, 11009
- Hospital Puerta del Mar
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Granada, 스페인, 18013
- Hospital Clinico Universitario San Cecilio
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos
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Madrid, 스페인, 28046
- Hospital La Paz
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Madrid, 스페인, 28041
- Hospital 12 de Octubre
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Sevilla, 스페인, 41013
- Hospital Virgen Del Rocio
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Sevilla, 스페인, 41014
- Hospital De Valme
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Sevilla, 스페인, 41008
- Hospital Virgen Macarena
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Valencia, 스페인, 46014
- Consorcio Hospital General
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Valladolid, 스페인, 47011
- Hospital Clínico de Valladolid
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Alava
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Vitoria, Alava, 스페인, 01009
- Hospital de Txagorritxu
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Barcelona
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Hospitalet de Llobregat, Barcelona, 스페인, 08907
- Hospital de Bellvitge
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Cádiz
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Jerez de la Frontera, Cádiz, 스페인, 11407
- Hospital de Jerez
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Gran Canaria
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Las Palmas, Gran Canaria, 스페인, 35016
- Hospital Insular
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Guipúzcoa
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San Sebastián, Guipúzcoa, 스페인, 20014
- Hospital de Donostia
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La Coruña
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Santiago, La Coruña, 스페인, 15705
- Complejo Hospitalario Universitario
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Madrid
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Alcorcón, Madrid, 스페인, 28922
- Fundacion Hospital de Alcorcon
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Mallorca
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Palma de Mallorca, Mallorca, 스페인, 07014
- Hospital Son Dureta
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients on treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) who are RNA-HCV undetectable at 44 week
- RNA-HCV positive at 48 week before study and genotype 1 or 4.
- HIV-1 positive: ELISA y Western-blot.
- Stable status of HIV-1 infection in the opinion of the investigator, (patients who are not expected to progress during the study).
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 6 months after treatment end. This may include, but is not limited to, using birth control pills, IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state.
- Willingness to give written informed consent and willingness to participate to and comply with the study.
Exclusion Criteria:
- Patients with RNA-HCV detectable after 44 weeks of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day).
- Patients with other treatment for chronic hepatitis, different which of inclusion criteria is described.
- More of tree weeks from the end of treatment with Peginterferon alfa-2a (180 µg/week) in combination with Ribavirin (1000-1200 mg/day) to the inclusion in "EXTRADOS" trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 2
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실험적: 1
Peginterferon alfa-2a 180 mcg/week + 1000-1200 mg/day ribavirin during 24 weeks
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Peginterferon alfa-2a 180 mcg/week ribavirin 1000-1200 mg/day during 24 weeks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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% of patients with RNA-HCV undetectable
기간: at 48 week of study (24 weeks after the end of treatment period of trial).
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at 48 week of study (24 weeks after the end of treatment period of trial).
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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% of percentage of patients with RNA-HCV undetectable
기간: 24 weeks of trial period
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24 weeks of trial period
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공동 작업자 및 조사자
수사관
- 연구 의자: José Hernández-Quero, Dr, Hospital Clinico Universitario San Cecilio
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Extrados
- 2004-004948-45
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