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Safety and Efficacy of Oral Miltefosine in Patients With Post Kala Azar Dermal Leishmaniasis (PKDL)

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ClinicalTrials.gov Identifier: NCT01635777
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
AB Foundation

Study Description
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Brief Summary:
Miltefosine efficacy will be >85%

Condition or disease Intervention/treatment Phase
PKDL Drug: Miltefosine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Miltefosine

Arms and Interventions
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Arm Intervention/treatment
Experimental: 12 weeks
miltefosine 12 weeks
 Drug: Miltefosine
2.5 mg/kg/day for 12 weeks
Experimental: 8 weeks
miltefosine 8 weeks
 Drug: Miltefosine
2.5 mg/kg/day for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Cure rate [ Time Frame: 12 months after end of treatment ]

Secondary Outcome Measures :
  1. adverse events [ Time Frame: during therapy: the 8 weeks of therapy for the 8 week treatment group and 12 weeks of therapy for the 12 week treatment group ]
    gastrointestinal events: vomiting and diarrhea


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 years or older
  • nodules and papules consistent with post kala-azar dermal leishmaniasis
  • parasitological confirmation of Leishmania infection

Exclusion Criteria:

  • platelet count <100x 109/l,
  • leukocyte count <2.5 x 109/l ,
  • hemoglobin < 8.0 g/100 ml ,
  • liver function tests >3 times upper limit of normal range,
  • bilirubin >2 times upper limit of normal range,
  • serum creatinine or blood urea nitrogen >1.5 times upper limit of normal range);
  • any non-compensated or uncontrolled condition,
  • lactation, pregnancy, or likelihood of inadequate contraception in females of childbearing potential for the treatment period plus 2 months thereafter;
  • treatment with any anti-leishmanial drug within the previous 12 weeks.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01635777


Locations
India
Institute of Medical Sciences, Banaras Hindu University,
Varanasi, India, 221005
Sponsors and Collaborators
AB Foundation
World Health Organization
More Information
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Responsible Party: AB Foundation
ClinicalTrials.gov Identifier: NCT01635777     History of Changes
Other Study ID Numbers: Z015
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by AB Foundation:
PKDL
miltefosine

Additional relevant MeSH terms:
Miltefosine
Antifungal Agents
Anti-Infective Agents
 Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents