Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only
Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors
연구 개요
상세 설명
RTNI (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. The presence of a smaller or greater degree of cross resistance among all RTNI is increasingly better described and acknowledged, whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited.
This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate. This therapeutic approach has demonstrated its effectiveness in clinical practice, albeit not in this scenario.
If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options.
To intensify with this proactive approach these combinations based on N/NNRTI (nucleotide analog), the NNRTI are an optimal alternative.There is vast experience with NVP in simplification/maintenance trials. In direct comparative simplification studies in patients with virological response, the response rates with NVP or EFV have shown no differences. With a relative risk (RR) of virological failure of 0.54 with regard to the continuation of PI (protease inhibitors), NVP is one of the best simplification treatment options in HIV-1-infected patients.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Barcelona, 스페인, 08035
- Hospital Vall d'hebrón
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Barcelona, 스페인, 08036
- Hospital Clinic i Provincial de Barcelona
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Barcelona, 스페인, 08009
- Centre Penitenciari Brians
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Barcelona, 스페인, 08025
- Hopsital de Sant Pau
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Barcelona, 스페인, 08370
- Hospital Sant Jaume de Calella
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Barcelona, 스페인
- Centre Penitenciari Homes
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Madrid, 스페인, 28040
- Hospital Clínico San Carlos de Madrid
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Tortosa, 스페인, 43500
- Hospital de Tortosa
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Valencia, 스페인, 46009
- Hospital La Fe de Valencia
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Zaragoza, 스페인, 50009
- Hospital Miguel Servet
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Barcelona
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Badalona, Barcelona, 스페인, 08916
- Hospital.Universitari Germans Trias i Pujol
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Granollers, Barcelona, 스페인, 08400
- Hospital General de Granollers
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Granollers, Barcelona, 스페인, 08430
- Centre Penitenciari Quatre Camins
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Hospitalet de Llobregat, Barcelona, 스페인, 08907
- Hospital de Bellvitge
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Terrassa, Barcelona, 스페인, 08221
- Mútua de Terrassa
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Canarias
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Tenerife, Canarias, 스페인, 38010
- Hospital La Candelaria
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Tarragona
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Reus, Tarragona, 스페인, 43201
- Hospital Universitari Sant Joan de Reus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.
- Age >= 18 years.
- Confirmed diagnosis of HIV-1 infection.
- Viral load < 50 copies/ml over the previous six months, including at least two consecutive determinations.
- Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.
- Acceptance and signature of the informed consent form.
Exclusion Criteria:
- Pregnant women or those who intend to become pregnant in the study period.
- Having had an active infection in the previous month.
- Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).
- Simultaneous treatment with methadone.
- Patients with serious hepatic dysfunction
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: 1
Follow with same ARV treatment
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실험적: 2
Switch one of ARV drugs to Nevirapine
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Switch one of ARV drugs to Nevirapine
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Proportion of patients with plasma viral load below 50 copies/mL .
기간: after 48 weeks of follow-up
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after 48 weeks of follow-up
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2차 결과 측정
결과 측정 |
기간 |
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Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).
기간: During the 48 weeks of follow-up.
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During the 48 weeks of follow-up.
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Evolution of the CD4 lymphocyte count at 48 weeks.
기간: during 48 weeks of follow-up
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during 48 weeks of follow-up
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Pattern of mutations associated with resistance in patients presenting virological failure.
기간: When there is a virological failure
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When there is a virological failure
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Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.
기간: during the 48 weeks of follow-up
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during the 48 weeks of follow-up
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Incidence of AIDS-defining events (CDC C events, 1993).
기간: during the 48 weeks of follow-up
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during the 48 weeks of follow-up
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Mortality by any cause.
기간: during the 48 weeks of follow-up
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during the 48 weeks of follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Josep Mª Llibre, MD,PhD, Hospital Sant Jaume de Calella
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
- TRIMUNE
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