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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Mar 20, 2009

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Idiopathic CD4+ lymphocytopenia (ICL), where patients have low levels of a specific type of white blood cell called CD4+ lymphocytes. This low cell count can make individuals more vulnerable to infections and other health issues. The goal of the trial is to better understand how ICL develops, how it affects patients over time, and whether it is linked to other problems like autoimmune diseases or certain types of cancer. Researchers will collect blood samples and conduct various health evaluations to learn more about the immune system of people with ICL and how to treat any infections they may have.

To participate in this study, individuals must be at least 18 years old and have a low CD4+ count on two separate occasions. They also need to be in regular care with a doctor and willing to allow their blood and tissue samples to be stored for future research. Patients who have certain infections, cancers, or other immune disorders will not be eligible. Participants can expect to attend an initial visit for thorough health assessments, followed by regular check-ups for up to ten years to monitor their condition and overall health. This trial aims to improve the understanding of ICL and ultimately enhance care for those affected.

Gender

ALL

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.