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The oral agent miltefosine has demonstrated a >95% cure rate in Indian visceral leishmaniasis. We performed a large, placebo-controlled study of miltefosine therapy (2.5 mg/kg per day orally for 28 days) against cutaneous leishmaniasis in Colombia and Guatemala. In regions in Colombia where Leishmania vianna panamensis is common, the per-protocol cure rates(More)
BACKGROUND There are 500,000 cases per year of visceral leishmaniasis, which occurs primarily in the Indian subcontinent. Almost all untreated patients die, and all the effective agents have been parenteral. Miltefosine is an oral agent that has been shown in small numbers of patients to have a favorable therapeutic index for Indian visceral leishmaniasis.(More)
Miltefosine has previously been shown to cure 97% of cases of visceral leishmaniasis (VL) in Indian adults. Because approximately one-half of cases of VL occur in children, we evaluated use of the adult dosage of miltefosin (2.5 mg/kg per day for 28 days) in 80 Indian children (age, 2-11 years) with parasitologically confirmed infection in an open-label(More)
BACKGROUND Visceral leishmaniasis (VL) is a major public health problem in Bihar, accounting for 90% of all cases in India. Development of high levels of resistance to various existing drugs necessitated the search for alternative orally administered drugs. Hospital-based studies have shown that oral miltefosine is a highly effective treatment for VL both(More)
BACKGROUND Miltefosine is the first oral drug with demonstrable success in treating visceral leishmaniasis in adults. Because approximately one-half of the visceral leishmaniasis patients worldwide are children, we performed a Phase I/II dose ranging study in the pediatric population in India. METHODS Thirty-nine (39) children (defined as < 12 years of(More)
Oral miltefosine was administered to 39 human immunodeficiency virus (HIV)-infected patients with leishmaniasis for whom standard leishmaniasis treatment had failed. Initial response was achieved in 25 patients (64%), including 16 patients (43%) with initial parasitological cure. Repeated responses after relapse and tolerability of long courses of treatment(More)
BACKGROUND A 31-year-old man who has suffered since age 3 from diffuse cutaneous leishmaniasis (DCL), a disease with profound physical and psychosocial repercussions and no effective treatment at present, was treated with miltefosine. METHODS The patient was treated for 120 days, 100 mg/day for 1 week, then 150 mg/day subsequently. RESULTS Lesions were(More)
Miltefosine was originally formulated and registered as a topical treatment for cutaneous cancers. For this indication and in subsequent development for leishmaniasis, a large body of non-clinical data has been generated. The gastrointestinal organ is the main site of toxicity, in both animal and in human studies. The testis and retina were identified as(More)
PURPOSE Perifosine is an orally applicable, membrane-targeted alkylphosphocholine analogue with antitumour activity and radiosensitising properties in preclinical models. The purpose of this phase I study was to determine the feasibility and tolerability of concurrent daily perifosine and radiation in patients with advanced cancer. PATIENTS AND METHODS(More)
Miltefosine is a novel antileishmanial drug that has significant selectivity in both in vitro and in vivo models. Clinical efficacy was demonstrated for the treatment of visceral leishmaniasis with the advantage of oral administration over the currently recommended antileishmanial drugs that require parenteral administration. Miltefosine produces high cure(More)