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Short Course of Miltefosine and Antimony to Treat Cutaneous Leishmaniasis in Bolivia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00537953
Recruitment Status : Unknown
Verified September 2007 by Centro de Investigaciones Bioclínicas de la Fundación Fader.
Recruitment status was:  Recruiting
First Posted : October 2, 2007
Last Update Posted : October 2, 2007
Information provided by:
Centro de Investigaciones Bioclínicas de la Fundación Fader

Brief Summary:
The combination of a half-course of miltefosine and a half-course of antimony will be evaluated for efficacy and tolerance. The combination of miltefosine and antimony is chosen because these are now the two standard agents in Bolivia, and in vitro the combination was additive to mildly synergistic against a standard leishmania strain.

Condition or disease Intervention/treatment Phase
Cutaneous Leihmaniasis Drug: Miltefosine , meglumine antimoniate Phase 2

Detailed Description:

Combination therapy is now being used for many infectious diseases, such as tuberculosis, malaria, and HIV. Combination therapy offers the potential of preventing drug resistance, because organisms resistant to one of the drugs may be susceptible to the other drug; and also the potential to diminish drug therapy duration and thus side effects. These two potential benefits to some extent contradict each other: preventing resistance is best done if full courses of both drugs is used; diminishing therapy duration means using less than the full course of each drug. The optimum combination regimen is one in which sufficient amounts of both drugs are used to have high efficacy, yet the amounts are as low as possible to spare patients unnecessarily long courses of drug.

Until recently, the standard treatment for the leishmaniases was pentavalent antimony (Glucantime or Pentostam). The cure rate for L panamensis in Colombia is 91%-93% [Soto, 1993; Velez, 1997] and the cure rate in Bolivia, in work soon to be completed, is also 90% [ Soto, unpublished results]. A large study with several formulations of antimony found a combined Bolivia-Colombia cure rate of 86% [Soto, 2004b]. Nevertheless, pentavalent antimonials have the disadvantages of multiple injections and mild-moderate clinical toxicity [gastrointestinal complaints, liver enzyme elevations, pancreatic enzyme elevations], all of which are particularly unpleasant for a moderate clinical problem such as cutaneous leishmaniasis.

The oral agent Miltefosine has now been shown to be as effective as antimony in Colombia and Bolivia. In Colombia, the cure rate for miltefosine was 91% [Soto 2004a] and in the soon to be completed comparative trial in Bolivia, the cure rate for miltefosine appears to be 92% [Soto, unpublished results]. Side effects seen in patients with cutaneous disease that can be specifically attributed to the drug are nausea and vomiting of mild grade in approximately 25% of patients, and low-grade elevation of creatinine also in approximately 25% of patients [Soto 2001; Soto 2004]. A further disadvantage of miltefosine is that regimens shorter than 4 weeks have not been evaluated for cutaneous disease.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Gender: Male Age: Adults Presentation: At least 1 lesion must be ulcerative. Parasitology: Parasitological confirmation of 1 lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion.

Exclusion Criteria:

  • Previous treatment for leishmaniasis, specific or putatively specific therapy (Sb, pentamidine, amphotericin B, imidazoles, allopurinol)
  • Other concomitant diseases by history and by approximately normal complete blood counts (white blood count, hemoglobin, platelet count), values of liver transaminases (SGOT), values of pancreatic function (lipase), kidney function tests (creatinine), and EKG.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00537953

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Contact: Jaime Soto, MD 571 348 2171
Contact: Julia Toledo, MD 571 347 6093

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Hospital Dermatológico Recruiting
Jorochito, Santa Cruz, Bolivia, 00000
Contact: Renato Amonzabel, MD    5813 382 3001   
Sub-Investigator: David Paz, MD         
Sponsors and Collaborators
Centro de Investigaciones Bioclínicas de la Fundación Fader
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Study Chair: Jonathan Berman, MD, PhD AB Foundation for Medical Research
Principal Investigator: Jorge Vargas, MD Cenetrop
Layout table for additonal information Identifier: NCT00537953    
Other Study ID Numbers: 2007-Bol/LC-1339
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: September 2007
Keywords provided by Centro de Investigaciones Bioclínicas de la Fundación Fader:
Cutaneous leishmaniasis
Pentavalent antimonials
Combination therapy
Additional relevant MeSH terms:
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Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Meglumine Antimoniate
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents