EUCTR2011-004693-29-IT进行中（未招募）不适用
Pegylated interferon alfa-2a USE FOR CONTROLLING virological rebound after suspension of antiretroviral treatment IN PATIENTS WITH CHRONIC HIV INFECTION - IFNHIV
ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI0 个研究点目标入组 40 人开始时间: 2012年3月2日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Will be enrolled only patients who require interruption of HAART for toxicity or who spontaneously decide to suspend the anti-HIV therapy. • Patients male and female with age between 18 and 65 years. • Aware of providing informed consent • Patients with HIV infection with ELISA and Western Blot documented, with a stable viral load suppressed by at least 18 months in the course of antiretroviral treatment effective. • HIV RNA <40 copies / mL and CD4> 500 cells / mL (nadir = 250 cells / mL) conscription • HIV RNA> 10,000 copies / mL before the antiretroviral treatment • For female patients negative pregnancy test (Beta HCG) and use of effective contraception during the study • Karnofsky score = 80% • Adherence to treatment regimen and the planned study • Abstention from the use of immunomodulatory drugs during the study • Thyroid function in the norm
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy in place and / or breastfeeding • CD4 + cell counts <500 cells or nadir CD4 <250 cells / mL. • History of immune-modulating therapies for over 2 weeks during the 6 months prior to enrollment as interferons, corticosteroids, cancer chemotherapy, cyclosporine, tacrolimus, OKT3, interleukins (IL2, IL7), cyclophosphamide, methotrexate, immunoglobulins, G/M- CSF hydroxyurea, thalidomide, pentoxifylline, timopentina, thymosin • Other concurrent medical conditions, anemia (Hgb <9.1), neutropenia (<1000), thrombocytopenia (platelets <50,000), citonecrosi liver (AST / ALT x5), renal insufficiency (creatinine> x2), drug addiction, alcohol abuse, uncontrolled diabetes mellitus • History of heart disease • History of depression and / or severe psychiatric disorders • Chronic hepatitis HBV co • History of autoimmune disorders including: Crohn's disease, ulcerative colitis the rectum, psoriasis, rheumatoid arthritis, myositis • History of trapaianto • Hypersensitivity to interferon
研究者
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