Phase IV.II Pilot Study of Treatment of Cytomegalovirus Infection With a Brief Induction With Ganciclovir i.v. Followed by Valganciclovir Oral in Solid Organ Transplant Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).
研究概览
简要总结
The objectives of this study were:
- To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment.
- To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).
- Evaluate the security of this treatment with valganciclovir.
详细描述
SOT recipients (kidney, liver and heart transplant) presenting CMV infection or disease were eligible for inclusion if they were ≥18 years of age and presented a positive CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC). Patients excluded were those with severe CMV tissue invasive disease, unable to receive oral medication, absolute neutrophil counts less than 500/ mm3, platelets <25000 platelets/mm3, Hemoglobin< 80g/l or estimated glomerular filtration rate< 10 mL/min (according to the Cockcroft-Gault formula).
Patients received a short induction treatment with ganciclovir i.v (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at the dose of 5 mg/kg/12h, by a peripherical vein infusion of one hour, during 5 days followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg/12h during 16 days, after meals, until complete a total of 21 days of treatment. In patients with impaired renal function ganciclovir i.v. and oral valganciclovir doses were adjusted at each visit according to estimated Glomerular Filtration Rate (GFR) by Cockcroft-Gault equation, as recommended by the manufacturer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •≥18 years of age, solid organ transplant recipients.
- •presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC).
- •gave written informed consent.
排除标准
- •HIV patients.
- •Multiorganic transplant.
- •Severe CMV tissue invasive disease.
- •Unable to receive oral medication.
- •absolute neutrophil counts less than 500/ mm
- •Platelets <25000 platelets/mm
- •Hemoglobin< 80g/l.
- •Estimated glomerular filtration rate< 10 mL/min (according to the Cockcroft-Gault formula)
研究组 & 干预措施
Single arm
Patients received a short induction of IV ganciclovir (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 5 mg/kg bid for 5 days (1 hour infusion) , followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg bid (after meals) for 16 days up to complete 21 days of treatment. In patients with impaired renal function, IV ganciclovir and oral valganciclovir doses were adjusted at each visit according to estimated GFR (Cockcroft-Gault equation)
干预措施: Single arm (ganciclovir and valganciclovir) (Drug)
结局指标
主要结局
Dissapeareance of CMV (pp65) antigenemia, determined in peripheral blood mononuclear cells (PBMC).
时间窗: Baseline, day 5, 10, 15, 21 of treatment and day 30, 60 and 90 of follow-up.
次要结局
- Dissapareance of Cytomegalovirus viremia measured by PCR, determined in plasma samples.(Basal, day 5, 10, 15 and 21 of treatment and 30, 60 and 90 of treatment.)
- Area under the curve (AUC) of Ganciclovir after ganciclovir i.v. and valganciclovir oral in steady state.(Day 5 (ganciclovir i.v) and day 15 (valganciclovir oral))
研究者
Salvador Gil-Vernet
Nephrologist
Hospital Universitari de Bellvitge