Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 17
- 主要终点
- Proportion of patients with plasma viral load below 50 copies/mL .
研究概览
简要总结
The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
2
Switch one of ARV drugs to Nevirapine
干预措施: Nevirapine (Drug)
结局指标
主要结局
Proportion of patients with plasma viral load below 50 copies/mL .
时间窗: after 48 weeks of follow-up
次要结局
- Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).(During the 48 weeks of follow-up.)
- Evolution of the CD4 lymphocyte count at 48 weeks.(during 48 weeks of follow-up)
- Pattern of mutations associated with resistance in patients presenting virological failure.(When there is a virological failure)
- Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.(during the 48 weeks of follow-up)
- Incidence of AIDS-defining events (CDC C events, 1993).(during the 48 weeks of follow-up)
- Mortality by any cause.(during the 48 weeks of follow-up)