Status:
COMPLETED
Mechanisms Relating to the Distinct in Vitro Susceptibility of Human Macrophages to L. Viannia Infection
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 how the body defends itself against Leishmania (Viannia), a parasite that can cause a skin infection and skin sores. Certain cells in the immune system act mo...
Detailed Description
This is a cross-sectional study that aims to determine the mechanisms that lead to the distinct in vitro susceptibility of human macrophages to L. Viannia infection, and their relationship to clinical...
Eligibility Criteria
Inclusion
- For specific objectives 1, 3 and 4:
- Historical cases of chronic disease:
- Age between 18-70 years
- Historic parasitologically confirmed, skin test positive cutaneous leishmaniasis (CL) patients who presented chronic CL lesions of \> 6 months duration at the time of diagnosis
- No active lesions
- Voluntary participation in the study
- Written and signed Informed consent for HIV testing and participation in the study
- Historical cases of recurrent disease:
- Age between 18-70 years
- Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
- No active lesions
- Voluntary participation in the study
- Written and signed Informed consent for HIV testing and participation in the study
- Asymptomatic infection:
- Age between 18-70 years
- Resident of endemic area
- No history or evidence of active or prior dermal leishmaniasis
- Voluntary participation
- Written and signed Informed consent for HIV testing and participation in the study
- Healthy donors:
- Age between 18-70 years
- No history or evidence of exposure to transmission of leishmaniasis
- Voluntary participation
- Written and signed Informed consent for HIV testing and participation in the study
- For specific objective 2:
- Historical cases of chronic disease:
- Age between 18-70 years
- 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
- Written and signed Informed consent for HIV testing and participation in the study
- Historical cases of recurrent disease:
- Age between 18-70 years
- Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
- No active lesions
- Voluntary participation in the study
- Written and signed Informed consent for HIV testing and participation in the study
- Asymptomatic infection:
- Age between 18-70 years
- Resident of endemic area
- No history or evidence of active or prior dermal leishmaniasis
- Voluntary participation
- Written and signed Informed consent for HIV testing and participation in the study
- Healthy donors:
- Age between 18-70 years
- No history or evidence of exposure to transmission of leishmaniasis
- Voluntary participation
- Written and signed Informed consent for HIV testing and participation in the study
Exclusion
- Exclusion criteria for all groups (for specific objectives 1, 3 and 4):
- Immunosuppressive disease
- Pharmacotherapy with drugs that are immunosuppressive
- Pregnancy
- Breastfeeding
- Unwillingness to participate
- Exclusion criteria for all groups (for specific objective 2):
- Weight below 50kg
- Immunosuppressive disease (HIV)
- Treatment with drugs that are immunosuppressive
- Pregnancy
- Breastfeeding
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00401557
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