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The purpose of this Treatment IND is to make miltefosine available for mucocutaneous leishmaniasis patients presenting in the United States.
If entrance criteria are met, subjects with mucosal or cutaneous leishmaniasis will receive miltefosine at a targeted dose of 2.5 mg/kg/day for 28 days. During treatment at weeks 1, 2, and 4, the patient will return to the treatment facility to be assessed for adverse events. Blood for transaminase and creatinine values will be drawn at the midpoint and at the end of therapy.
Patients will return to the treatment facility to be examined clinically at 6 wks (ie, 2 wks after the end of therapy), 3 months (2 months after therapy), and 7 months (6 months after treatment) for ML and CL patients, and also at 13 months (12 months after treatment) for ML patients.
Control: Historical Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
for this treatment IND, each Physician will enter patients at his/her own facility. Below data is for Protocol central contact
Paladin Labs (USA) Inc.
Published on BioPortfolio: 2014-08-27T03:16:34-0400
Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis
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Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse...
The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous st...
The purpose of this study is to determine the pharmacokinetics of miltefosine in children and adults with cutaneous leishmaniasis in plasma and intracellularly, and its relation with the p...
Miltefosine is currently the only oral drug for visceral leishmaniasis, and although deficiency in an aminophospholipid/miltefosine transporter (MT) is sufficient to elicit drug resistance, very few n...
Miltefosine has been used successfully to treat visceral leishmaniasis (VL) in India, but it was unsuccessful for VL in a clinical trial in Brazil.
Leishmaniasis is a neglected tropical disease caused by several different species of Leishmania. Treatment of leishmaniasis involves a limited drug arsenal that is associated with severe side effects,...
Convenient, safe, and effective treatments for visceral leishmaniasis in Eastern African children are lacking. Miltefosine, the only oral treatment, failed to achieve adequate cure rates in Eastern Af...
Pentavalent antimonials (Sbv) are the most commonly used drugs for the treatment of mucosal leishmaniasis (ML), despite their high toxicity and only moderate efficacy. The aim of this study was to rep...
A disease caused by any of a number of species of protozoa in the genus LEISHMANIA. There are four major clinical types of this infection: cutaneous (Old and New World) (LEISHMANIASIS, CUTANEOUS), diffuse cutaneous (LEISHMANIASIS, DIFFUSE CUTANEOUS), mucocutaneous (LEISHMANIASIS, MUCOCUTANEOUS), and visceral (LEISHMANIASIS, VISCERAL).
A parasitic hemoflagellate of the subgenus Leishmania leishmania that infects man and animals including rodents. The Leishmania mexicana complex causes both cutaneous (LEISHMANIASIS, CUTANEOUS) and diffuse cutaneous leishmaniasis (LEISHMANIASIS, DIFFUSE CUTANEOUS) and includes the subspecies amazonensis, garnhami, mexicana, pifanoi, and venezuelensis. L. m. mexicana causes chiclero ulcer, a form of cutaneous leishmaniasis (LEISHMANIASIS, CUTANEOUS) in the New World. The sandfly, Lutzomyia, appears to be the vector.
A parasitic hemoflagellate of the subgenus Leishmania viannia that infects man and animals. It causes cutaneous (LEISHMANIASIS, CUTANEOUS), diffuse cutaneous (LEISHMANIASIS, DIFFUSE CUTANEOUS), and mucocutaneous leishmaniasis (LEISHMANIASIS, MUCOCUTANEOUS) depending on the subspecies of this organism. The sandfly, Lutzomyia, is the vector. The Leishmania braziliensis complex includes the subspecies braziliensis and peruviana. Uta, a form of cutaneous leishmaniasis in the New World, is caused by the subspecies peruviana.
An endemic disease that is characterized by the development of single or multiple localized lesions on exposed areas of skin that typically ulcerate. The disease has been divided into Old and New World forms. Old World leishmaniasis is separated into three distinct types according to epidemiology and clinical manifestations and is caused by species of the L. tropica and L. aethiopica complexes as well as by species of the L. major genus. New World leishmaniasis, also called American leishmaniasis, occurs in South and Central America and is caused by species of the L. mexicana or L. braziliensis complexes.
A parasitic hemoflagellate of the subgenus Leishmania viannia that infects man and animals and causes mucocutaneous leishmaniasis (LEISHMANIASIS, MUCOCUTANEOUS). Transmission is by Lutzomyia sandflies.