Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00867269 |
Background:
Objectives:
Eligibility:
Design:
Condition |
---|
Idiopathic CD4+ Lymphocytopenia Cryptococcal Meningitis Warts |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia |
Estimated Enrollment: | 100 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | February 2019 (Final data collection date for primary outcome measure) |
Idiopathic CD4+ lymphocytopenia (ICL) is a disorder characterized by decreased numbers of circulating CD4+ T lymphocytes in the absence of known causes of CD4+ lymphocytopenia. ICL is defined as an absolute CD4+ T cell count of less than 300 cells/mL in a patient with no human immunodeficiency virus infection or known immunodeficiency syndrome. The causes and frequency of the disorder remain unknown. The condition is typically diagnosed when patients present with a serious infection. In this natural history protocol, we will evaluate patients with CD4+ T cell counts below 300 cells/microL. We propose to follow 100 patients for a minimum of 4 and maximum of 10 years, with a particular focus on the association between ICL and autoimmune disease. We will collect blood for immunologic, rheumatologic, and genetic testing in an effort to identify and understand the underlying defects that cause ICL and follow its course in a cohort of patients who will receive best standard therapy for opportunistic infections.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible for this study, patients must satisfy all of the following inclusion criteria:
EXCLUSION CRITERIA:
Patients will be ineligible for this study if they satisfy any of the following criteria:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 090102, 09-I-0102 |
Study First Received: | March 20, 2009 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00867269 History of Changes |
Health Authority: | United States: Federal Government |
Idiopathic Lymphocytopenia Opportunistic Infection Immunodeficiency Syndrome |
Autoimmune Disease CD4+ Lymphocytes Idiopathic CD4 Lymphocytopenia |
Opportunistic Infections Meningitis, Fungal Autoimmune Diseases Hematologic Diseases Lymphopenia Central Nervous System Diseases Leukocyte Disorders Immunologic Deficiency Syndromes Meningitis |
Absent T Lymphocytes Mycoses Warts Central Nervous System Infections Meningitis, Cryptococcal Central Nervous System Fungal Infections Leukopenia Cryptococcosis |
Meningitis, Fungal Immune System Diseases Hematologic Diseases Nervous System Diseases Lymphopenia Central Nervous System Diseases Leukocyte Disorders Immunologic Deficiency Syndromes |
Meningitis Mycoses Central Nervous System Infections Meningitis, Cryptococcal Central Nervous System Fungal Infections Leukopenia Cryptococcosis |