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Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia

NCT00867269 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 950

Last updated 2026-05-07

No results posted yet for this study

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 autoimmune disorders and diseases.

Objectives:

* 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.

Eligibility:

* 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.

Design:

* 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.

Conditions

  • Idiopathic CD4+ Lymphocytopenia
  • Cryptococcal Meningitis
  • Warts

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Irini Sereti, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00867269 on ClinicalTrials.gov