Leishmaniasis Clinical Trial
Official title:
Intervenable Host- Leishmania (Vianna) Interactions Project 3: Immune and Inflammatory Responses in L. (Viannia) Infection Aim 1: To Determine if Th1/Th2 Polarization Occurs and is Linked to the Outcome of Infection by L. Viannia
Verified date | August 2011 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 leishmanial lesions, or are healthy are being invited to participate in this study. Approximately 150 people will participate in the study. Participants will be asked to provide some general information about themselves and about skin sores, if they have any. A skin test will be performed and a blood sample will be obtained. This study involves up to 3 visits; the first visit will last up to 5 hours and the second visit will last for 30 minutes. The third visit may be scheduled within 3 days after the second visit.
Status | Completed |
Enrollment | 122 |
Est. completion date | April 2010 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 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 Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Colombia | Centro Internacional de Entrenamiento e Investigaciones Medicas, CIDEIM | Cali |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Allergy and Infectious Diseases (NIAID) |
Colombia,
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