Understanding Idiopathic CD4+ Lymphocytopenia and its Effects

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

This study is trying to understand how Idiopathic CD4+ lymphocytopenia affects people over time by looking at their immune system and any related health issues while they receive standard treatment for infections.

Quick facts

• Study type: Observational
• Enrollment: 950 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00867269 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed CD4+ T cell count below 300 cells/microL on multiple occasions.

Not a fit: Patients with known HIV infections, other immunodeficiency syndromes, active malignancies, or those who have recently taken medications that affect CD4+ counts will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of ICL and improved management strategies for patients affected by this condition.

How similar studies have performed: While the specific approach of this study is novel, similar studies have shown success in understanding other immunodeficiencies and their management.

Eligibility criteria

* 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 this trial is running

Bethesda, Maryland

• 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.

Conditions Idiopathic CD4+ Lymphocytopenia; Cryptococcal Meningitis; Warts; Opportunistic Infection; Immunodeficiency Syndrome; Autoimmune Disease; CD4+ Lymphocytes; Natural History