Status:
RECRUITING
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Idiopathic CD4+ Lymphocytopenia
Cryptococcal Meningitis
Eligibility:
All Genders
18+ years
Brief Summary
Background: * Idiopathic CD4+ lymphocytopenia (ICL) is a condition in which there is a decreased level of CD4+ lymphocytes (a type of white blood cell), which can lead to opportunistic infections or ...
Detailed Description
Idiopathic CD4+ lymphocytopenia (ICL) is a disorder characterized by decreased numbers of circulating CD4+ T lymphocytes in the absence of known causes of CD4+ lymphocytopenia. ICL is defined as an ab...
Eligibility Criteria
Inclusion
- ICL PARTICPANT INCLUSION CRITERIA:
- To be eligible for this study, patients must satisfy all of the following inclusion criteria:
- Age greater than or equal to 18 years
- Absolute CD4 count \< 300 cells/microL or \< 20% of total T cells on at least two occasions at least 6 weeks apart
- Ongoing care by a referring primary care physician
- Willingness to allow storage of blood and tissue samples for future analysis
- ICL PARTICPANT EXCLUSION CRITERIA:
- Patients will be ineligible for this study if they satisfy any of the following criteria:
- Known infection with HIV-1, HIV-2, or human T-cell lymphotropic viruses (HTLV-1 or HTLV-2) as demonstrated by enzyme-linked immunosorbent assay (ELISA) and western blot and/or viral load testing
- Known underlying immunodeficiency syndrome other than ICL
- Evidence of active malignancy
- Receipt of medications, herbal substances, or biologic agents known to diminish the CD4+ count within 30 days of when the CD4+ lymphocytopenia was detected
- Any condition that in the judgment of the investigators would place the subject at undue risk or compromise the results of the study.
- BLOOD RELATIVE INCLUSION CRITERIA:
- To be eligible for study participation as a blood relative, subjects must be greater than or equal to 18 years of age and be a blood relative of an individual who meets or has met the CDC criteria for ICL.
- HOUSEHOLD CONTACT INCLUSION CRITERIA:
- To be eligible for study participation as a household contact, subjects must be greater than or equal to18 years of age and live within the same household as an ICL subjects participating in this protocol. Blood relatives who are household contacts are eligible to participate.
Exclusion
Key Trial Info
Start Date :
July 13 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
950 Patients enrolled
Trial Details
Trial ID
NCT00867269
Start Date
July 13 2009
Last Update
January 5 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892