Status:
COMPLETED
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
Lead Sponsor:
Access to Advanced Health Institute (AAHI)
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Leishmaniasis, Mucocutaneous
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with s...
Detailed Description
Mucosal leishmaniasis is a disfiguring and possibly fatal infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Peru, the standard therapy is daily i...
Eligibility Criteria
Inclusion
- Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test
Exclusion
- Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00111514
Start Date
July 1 2004
End Date
May 1 2006
Last Update
February 15 2007
Active Locations (2)
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1
Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud
Cusco, Peru
2
Universidad Peruana Cayetano Heredia
Lima, Peru, 100