A randomized trial of AmBisomeÂ® monotherapy and combination of AmBisomeÂ® and miltefosine for the treatment of Visceral Leishmanaisis in HIV positive patients in India

Medecins Sans Frontieres0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
•Confirmed HIV positive test (2 rapid diagnostics tests (RDTs) as per National Programme guidelines, WB for any discrepancy
•Diagnosis of VL confirmed by bone marrow or spleen aspirate.
•Male and female age >= 18 years
•Written informed consent from the patient.

•Women of child-bearing potential 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 three months after.
•Pregnant women or breast-feeding mothers.
•Clinical or biological evidence of severe cardiac, renal or hepatic impairment.
•Known hypersensitivity to AmBisomeÂ® and/or miltefosine.
•Concomitant severe infection such as TB or other serious underlying disease that would preclude evaluation of patients response to study medication
•Hb <5mg/dl, WBC <1x103/mm3, platelets <40,000/mm3
•Abnormal liver function tests (ALT/AST) more than 3 times the upper limit of normal
•Creatinine >1.2

发起方