Understanding Idiopathic CD4+ Lymphocytopenia and its Effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize the natural history of Idiopathic CD4+ lymphocytopenia (ICL), focusing on the CD4+ T cell count and the onset of infections, malignancies, and autoimmune diseases. It will follow 300 patients with ICL for a period ranging from 4 to 20 years, collecting blood and tissue samples for immunologic and genetic testing. The study also includes blood relatives and household contacts to explore potential genetic causes and the pathogenesis of ICL. The goal is to provide insights into the immunological status of patients while administering standard therapy for opportunistic infections.

Why it matters

Who can join: the full rules

* ICL PARTICPANT INCLUSION CRITERIA:

To be eligible for this study, patients must satisfy all of the following inclusion criteria:

1. Age greater than or equal to 18 years
2. Absolute CD4 count \< 300 cells/microL or \< 20% of total T cells on at least two occasions at least 6 weeks apart
3. Ongoing care by a referring primary care physician
4. 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:

1. 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
2. Known underlying immunodeficiency syndrome other than ICL
3. Evidence of active malignancy
4. Receipt of medications, herbal substances, or biologic agents known to diminish the CD4+ count within 30 days of when the CD4+ lymphocytopenia was detected
5. 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Irini Sereti, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Irini Sereti, M.D.
• Email: isereti@niaid.nih.gov
• Phone: (301) 496-5533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.