Status:
COMPLETED
Th1/Th2 Polarization and Linkage to L. Viannia Infection Outcomes
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Leishmaniasis
Eligibility:
All Genders
18-70 years
Brief Summary
The purpose of this study is to determine what types of cells participate in the defense of humans against Leishmania (skin parasites). People 18-70 years of age who have leishmaniasis, have healed le...
Detailed Description
The purpose of this study is to determine if Th1/Th2 polarization occurs and is linked to the outcome of infection by L. Viannia (asymptomatic, chronic or recurrent infection). This protocol is the fi...
Eligibility Criteria
Inclusion
- All Groups:
- \- Age between 18-70 years
- Inclusion Criteria for the 4 groups for specific objective 1:
- Historical cases of chronic disease:
- Historic parasitologically confirmed, skin test positive CL patients who presented chronic CL lesions of \> 6 months duration at the time of diagnosis.
- No active lesions
- Voluntary participation in the study
- Informed consent for HIV testing and participation in the study
- Historical cases of recurrent disease:
- Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
- No active lesions
- Voluntary participation in the study
- Informed consent for HIV testing and participation in the study
- Asymptomatic infection cases:
- Resident of endemic area
- PBMCs responsive to leishmanial antigen in culture
- No history or evidence of active or prior dermal leishmaniasis
- Voluntary participation
- Informed consent for HIV testing and participation in the study
- Healthy donors:
- No history or evidence of exposure to transmission of leishmaniasis
- Voluntary participation
- Informed consent for HIV testing and participation in the study
- Inclusion Criteria for the 2 groups for specific objective 2:
- Chronic disease group:
- Parasitologically confirmed chronic CL lesions of \> 6 months duration in skin test positive patients.
- Voluntary participation in the study
- Informed consent for HIV testing and participation in the study
- Recurrent disease group:
- Patients who have developed new parasitologically proven lesions after resolution of prior disease
- Voluntary participation in the study
- Informed consent for HIV testing and participation in the study
Exclusion
- Exclusion criteria all groups:
- Immunosuppressive disease
- Pharmacotherapy with drugs that are immunosuppressive
- Allergy/sensitivity to lidocaine family anesthetics or to latex
- Pregnancy
- Breastfeeding
- Unwillingness to participate
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00401297
Start Date
December 1 2006
End Date
April 1 2010
Last Update
March 30 2020
Active Locations (1)
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1
Centro Internacional de Entrenamiento e Investigaciones Medicas, CIDEIM
Cali, Colombia