Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID00867269

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-08

950

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Idiopathic CD4+ lymphocytopenia (ICL) is a condition marked by low levels of CD4+ T cells, which can increase the risk of infections, autoimmune diseases, and cancers. Researchers aim to understand the natural history of ICL by examining how CD4+ counts change over time, the onset of related infections and autoimmune issues, and possible genetic causes. The study also looks at the immune system status of patients and how it relates to disease development. The study involves patients with confirmed ICL, their blood relatives, and household contacts. Participants receive standard care to manage opportunistic infections. Initial visits include medical history, physical exams, blood tests, urine tests, and specialized evaluations as needed. Follow-up visits occur about once a year and continue for 4 to 10 years to monitor immune function and disease progression. Participants will undergo regular blood tests to measure CD4+ T cell counts and other immune markers, along with physical and rheumatology exams. Researchers will collect samples for immunologic, genetic, and microbiome analyses. The primary measure is CD4+ T cell count, tracked annually. The study monitors the effects of ICL over time and the relationship between immune status and infections or other conditions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 18 years
  • Absolute CD4 count less than 300 cells/microL or less than 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
  • Blood relatives must be 18 years or older and related to an individual meeting ICL criteria
  • Household contacts must be 18 years or older and live with an ICL subject
Not Eligible

You will not qualify if you...

  • Known infection with HIV-1, HIV-2, or human T-cell lymphotropic viruses (HTLV-1 or HTLV-2)
  • Known underlying immunodeficiency syndrome other than ICL
  • Evidence of active malignancy
  • Use of medications, herbal substances, or biologic agents that lower CD4+ count within 30 days of detection
  • Any condition that may pose undue risk or affect study results as judged by investigators

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - 4 to 20 years

Participants with idiopathic CD4+ lymphocytopenia, their blood relatives, and household contacts are followed to understand the natural history and pathogenesis of the condition through regular assessments and sample collections.

Annual visits for assessments and sample collection

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

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Research Team

I

Irini Sereti, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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