The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

University of Brasilia

Status and phase: Active, not recruiting; Phase 2

Conditions: Leishmaniasis

Treatments: Drug: Miltefosine; Drug: Meglumine antimoniate; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT02530697

40068714.1.0000.5558

Details and patient eligibility

About

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 effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
• For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
• Ages between 18 and 80 years old;
• Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
• Agree to participate in the study and sign the informed consent term.

Exclusion criteria

• Use of any leishmanicidal drugs six months prior;
• Clinical or laboratorial evidences of electrocardiographic disorders;
• Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
• Hypersensitivity to meglucamine antimoniate;
• Pregnancy or lactation;
• Fertile females that do not agree to use contraceptive methods;
• Patients that do not agree to the informed consent term.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Group 1 - Mucosal Antimoniate and Pentoxifylline

Active Comparator group

Description:

20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.

Treatment:

Drug: Meglumine antimoniate

Drug: Pentoxifylline

Group 2 - Mucosal Miltefosine and Pentoxifylline

Experimental group

Description:

Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.

Treatment:

Drug: Pentoxifylline

Drug: Miltefosine

Group 3 - Cutaneous Antimoniate and Pentoxifylline

Experimental group

Description:

20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.

Treatment:

Drug: Meglumine antimoniate

Drug: Pentoxifylline

Group 4 - Cutaneous Miltefosine and Pentoxifylline

Experimental group

Description:

Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.

Treatment:

Drug: Pentoxifylline

Drug: Miltefosine