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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001319 |
This study will evaluate HIV-negative patients with unusually low levels of CD4+ T lymphocytes (a type of white blood cell) to learn more about the clinical symptoms, cause, immunology, and biology of this problem. CD4+ T lymphocytes play an important role in immune function, and low counts may leave people susceptible to unusual infections. CD4+ T cell deficiencies are most often associated with HIV infection.
Patients 8 years of age and older with CD4+ T cell counts below 300 cells/mm3 who test negative for HIV infection by standard blood tests may be eligible for this study. Patients' family members and partners may also be enrolled to investigate the possible role of a genetic factor or exposure to some agent in this problem.
Patients will be evaluated at the NIH Clinical Center at least once, and generally two or more times. The evaluations, which may be done on an inpatient or outpatient basis, will include some or all of the following tests and procedures:
Family members will have 60 cc (4 tablespoons) of blood drawn to determine CD4+ T cell counts.
Condition |
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CD4 Lymphocytopenia Idiopathic CD4 Positive T Lymphocytopenia |
Study Type: | Observational |
Official Title: | Evaluation of the Epidemiology, Clinical Manifestations, Etiologies, and Immunology of Human Immunodeficiency Virus (HIV) Negative CD4 T Lymphocyte Deficient Patients |
Estimated Enrollment: | 100 |
Study Start Date: | September 1992 |
Estimated Study Completion Date: | July 2003 |
Low CD4+ T-cells in the absence of known etiology has been called idiopathic CD4+ T lymphocytopenia, and a case definition was established by the CDC as a CD4 count less than 300 cells/mL on 2 consecutive samples in a patient uninfected by HIV and with no other disease or treatment that might provide a reasonable alternative explanation for CD4 lymphocytopenia. Early investigations centered on a search for a novel retrovirus, but we and others have not found evidence of such a retrovirus. The patients that we have seen are heterogeneous, and it appears likely that there will be multiple etiologies for this syndrome. We are currently continuing to follow subjects long term and to see new subjects in order to continue to characterize the clinical aspects of patients who meet the case definition; to determine the natural history of ICL, and to provide samples to researchers who are interested in investigations into the pathogenesis of ICL.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
Adults greater than or equal to 18 years of age.
CD4 count less than 300 cells/mmL on 2 consecutive samples.
Uninfected by HIV as determined by ELISA with confirmatory Western Blot
Absence of disease or treatment that might provide a reasonable alternative explanation for the CD4 cell count or might confound the evaluation. Examples of such diseases would be any acute, severe medical illness that had not resolved when CD4 cell counts were obtained; active tuberculosis; leukemia or lymphoma; or previously characterized immunodeficiency disorder. Treatment that that might provide a reasonable alternative explanation includes chemotherapy over a field that could affect bone marrow or supraphysiologic glucocorticoid therapy.
Capable of providing informed consent.
Study ID Numbers: | 920256, 92-I-0256 |
Study First Received: | November 3, 1999 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00001319 |
Health Authority: | United States: Federal Government |
HIV Negative CD4 Deficiency Retrovirus |
Sexually Transmitted Diseases, Viral Hematologic Diseases Acquired Immunodeficiency Syndrome Lymphopenia T-Lymphocytopenia Leukocyte Disorders Immunologic Deficiency Syndromes |
Virus Diseases HIV Infections Sexually Transmitted Diseases T-Lymphocytopenia, Idiopathic CD4-Positive Leukopenia Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections |