Pilot Study to Assess the Safety and Efficacy of Switching the Nnrti or pi to Maraviroc in Hiv-1-infected Subjects With Persistent Viremia Suppression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Viral load
研究概览
简要总结
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.
详细描述
This is a 48 week randomized, prospective, controlled, open-label, proof-of-concept pilot clinical trial.
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or ATV/unboosted (in a regimen without tenofovir) or 1 NNRTI (nevirapine or efavirenz).
Patients will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.
The primary endpoint would be the percentage of patients who maintain virological suppression at week 48.
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
- •HIV-1 infected adults (=/+18 years old).
- •Patient having a diagnosis of HIV infection, on stable HAART including 2 NRTI/NtRTIs plus one of the following: 1 PI/ritonavir or ATV/unboosted or 1 NNRTI.
- •Undetectable plasma HIV-1 RNA (VL < 50 copies/mL) while on HAART.
- •Patient having at least one of the following conditions:
- •Antiretroviral-related gastrointestinal disturbances, or
- •Low patient's satisfaction associated with the current regimen posology (ritonavir use, ritonavir intolerance...), or
- •Any toxicity drug related.
- •Nadir CD4 cell count > 350 cells/mm
- •Absence of resistance mutations in the RT or PR by (TrugeneTM)
- •Good treatment adherence.
- •Voluntary written informed consent.
排除标准
- •Virologic failure to a previous antiretroviral regimen.
- •Any antiretroviral resistance mutation in a previous resistance test.
- •Dual/mixed or X4 viruses detected at any time point, including the pre-treatment ES-Trofile test of the PBMC test done before treatment switch.
- •Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion.
- •Pregnancy or fertile women willing to be pregnant.
研究组 & 干预措施
to switch from the NNRTI/PI to maraviroc
to switch from the NNRTI/PI to maraviroc
干预措施: maraviroc (Drug)
to continue with the same approach
to continue with the same approach
干预措施: control group (Drug)
结局指标
主要结局
Viral load
时间窗: 48 weeks
次要结局
- Time to virological failure(48 weeks)
- Administration of lipid-lowering drugs(48 weeks)
- Changes in the SCORE equation(48 weeks)
- CD4 / CD8 cell counts(48 weeks)
- Antiretroviral resistance and viral tropism(48 weeks)
- Patients who withdraw(48 weeks)
- Total cholesterol(48 weeks)
- HDL-cholesterol(48 weeks)
- LDL-cholesterol(48 weeks)
- Triglyceride(48 weeks)
研究者
Sílvia Gel
Dra. Eugenia Negredo
Germans Trias i Pujol Hospital