Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
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|ClinicalTrials.gov Identifier: NCT00867269|
Recruitment Status : Recruiting
First Posted : March 23, 2009
Last Update Posted : July 9, 2021
- 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 autoimmune disorders and diseases.
- To characterize the natural history with regard to CD4+ T cell count and onset of infection, malignancy, and autoimmunity.
- To describe the immunological status of patients affected by ICL while providing the best possible standard therapy to eradicate opportunistic infections.
- To establish the timeline of CD4 lymphocytopenia, with particular focus on defining subgroups of patients according to the decline, stabilization, or rise of CD4+ T cell counts over time.
- To characterize the opportunistic infections that occur in ICL patients at microbiologic and molecular levels.
- To characterize the immunophenotype and possible genetic immunodeficiency causes of ICL.
- To determine whether measurable immunologic parameters correlate with the development of opportunistic infections or other comorbidities such as lymphoma in patients with ICL.
- To determine whether there is any association between ICL and autoimmunity.
- To determine CD4+ T cell turnover, survival, functionality, and cytokine responsiveness in ICL patients.
- Patients 2 years of age and older with an absolute CD4 count less than 300 in children 6 years or older and adults or less than 20% of T cells in children younger than 6 on two occasions at least 6 weeks apart.
- Patients with negative results of HIV testing by ELISA, Western Blot, and viral load.
- Patients must not have underlying immunodeficiency conditions, be receiving cytotoxic chemotherapy (anti-cancer drugs that kill cells), or have cancer.
- At the initial visit to the National Institutes of Health, the following evaluations will be conducted:
- Personal and family medical histories.
- Physical examination, including rheumatology evaluation and other consultations as medically indicated (e.g., dermatology, pulmonology, ophthalmology, imaging studies).
- Blood samples for analysis of red and white blood cell counts, liver function, immune hormones, and antibody and autoantibody levels, white blood cell growth and function, and DNA.
- Urinalysis and urine pregnancy testing for female patients of childbearing age.
- Evaluation and treatment of active infections as medically indicated, including biopsies, buccal swabs, pulmonary function tests, and imaging studies.
- Follow-up visits will take place approximately every 12 months or more frequently if indicated, and will continue for a minimum of 4 years and a maximum of 10 years.
- Evaluations at follow-up will include blood samples (i.e., CBC with differential, biochemical profile, HIV testing, etc.) and urinalysis and rheumatology consults.
|Condition or disease|
|Idiopathic CD4+ Lymphocytopenia Cryptococcal Meningitis Warts|
|Study Type :||Observational|
|Estimated Enrollment :||950 participants|
|Official Title:||Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia|
|Actual Study Start Date :||July 13, 2009|
Blood Relatives of ICL subjects
Household contacts of ICL subjects
Patients with confirmed idiopathic CD4 lymphocytopenia
- CD4 <300/microliters or < 20% of total T cells and their blood [ Time Frame: Baseline and annually ]To further characterize the natural history of ICL while also investigating the genetic, environmental, and immunologic features of the condition.
- Determine CD4+ T cell turnover, survival, functionality and cytokineresponsiveness in selected ICL patients. [ Time Frame: Baseline and annually ]Collection of research blood (PBL, serum and plasma) for storage
- Investigate ICL immune cell homeostasis and trafficking by immunologic studies including tissue biopsies and the utilization of ahumanized mouse model. [ Time Frame: Baseline and annually ]Collection of research blood (PBL, serum and plasma) for storage
- Establish the prognosis of CD4 lymphocytopenia, with particular focus on defining subgroups of patients according to the decline, stabilization, or rise of CD4+T cell counts over time. [ Time Frame: Baseline and annually ]Collection of research blood (PBL, serum and plasma) for storage
- Determine whether measurable immunologic parameters correlate with the development of opportunistic infections or other co-morbidities [ Time Frame: Baseline and annually ]Determine whether measurable immunologic parameters correlate with the development of opportunistic infections or other co-morbidities such as lymphoma in patients with ICL. Investigate the associations between idiopathic CD4+ lymphocytopenia and autoimmunity.Collection of research blood (PBL, serum and plasma) for storage
- Determine the relationship between ICL and the microbiome. [ Time Frame: Baseline and annually ]Collection of rectal swab and dietary questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867269
|Contact: Irini Sereti, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Irini Sereti, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|