A Randomized Trial of Ambisome Monotherapy and Combination of Ambisome and Miltefosine for the Treatment of VL in HIV Positive Patients in Ethiopia Followed by Secondary VL Prophylactic Treatment With Pentamidine.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Initial parasitological cure at day 29
研究概览
简要总结
The overall objective of this trial is to identify a safe and effective treatment for visceral leishmaniasis (VL) in HIV co-infected Ethiopian patients.
Patients will receive either Ambisome alone or Ambisome in combination with Miltefosine.
Patients who do not undergo treatment failure will be given a VL prophylactic treatment with Pentamidine one month after the end of the study treatment.
详细描述
Visceral Leishmaniasis (VL) is a neglected disease which is fatal if left untreated. Ethiopia is one of the countries where the majority of cases occur. With spread of HIV in VL endemic areas an increase in co-infected cases has been reported in Ethiopia.
HIV and VL mutually influence each other as they both affect cellular immunity. The most important features of co-infection include poor outcome, increased drug toxicity and relapse of treatment with the need for maintenance therapy.
There are few studies in co-infected patients. There are no specific recommendations for HIV-VL co-infected patients in Ethiopia.
This protocol will evaluate the efficacy and safety of the combination of Ambisome with Miltefosine and Ambisome monotherapy (high dose) in Ethiopia.
It is designed as a randomised, parallel arm, open-label trial. No comparator will be included.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV positive test (2 rapid diagnostics tests (RDTs) followed by a confirmatory ELISA test).
- •Diagnosis of VL (first episode or relapse) confirmed by bone marrow or spleen aspirate.
- •Male and female age: 18-60 years.
- •Written informed consent from the patient.
排除标准
- •Women of child-bearing potential (defined as women who have achieved menarche) who are not using an assured method of contraception or are unwilling to use an assured method of contraception for the duration of treatment and four months after.
- •Pregnant women or breast-feeding mothers.
- •Patients with grade 2 or 3 post kala-azar dermal leishmaniasis (PKDL) lesions.
- •Clinical or biological evidence of severe cardiac, renal or hepatic impairment.
- •Known hypersensitivity to AmBisome® and/or miltefosine.
- •Patients receiving allopurinol treatment
研究组 & 干预措施
Liposomal Amphotericin B / Miltefosine
Liposomal Amphotericin B : 30mg/kg total dose: IV infusion 5mg/kg per day on day 1, 3, 5, 7, 9, 11
Miltefosine: orally taken every day during 28 days
- 1 x 50 mg capsule per day if patient weights less or equal to 25 kg
- 2 x 50 mg capsules per day if the patient weights more than 25 kg
干预措施: Liposomal Amphotericin B (Drug)
Liposomal Amphotericin B / Miltefosine
Liposomal Amphotericin B : 30mg/kg total dose: IV infusion 5mg/kg per day on day 1, 3, 5, 7, 9, 11
Miltefosine: orally taken every day during 28 days
- 1 x 50 mg capsule per day if patient weights less or equal to 25 kg
- 2 x 50 mg capsules per day if the patient weights more than 25 kg
干预措施: Miltefosine (Drug)
Liposomal Amphotericin B
Liposomal Amphotericin B: 40 mg/kg total dose : IV infusion of 5mg/kg per day on day 1 to 5, 10, 17, 24
干预措施: Liposomal Amphotericin B (Drug)
结局指标
主要结局
Initial parasitological cure at day 29
时间窗: Day 29
Absence of parasites in tissue aspirate at day 29; hence no rescue medication provided up to this time-point.
次要结局
- Relapse-free survival at day 390(Day 390)