Status:
COMPLETED
Evaluation of HIV-Negative Patients With Low CD4+ T Lymphocyte Counts
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
CD4 Lymphocytopenia
Idiopathic CD4 Positive T Lymphocytopenia
Eligibility:
All Genders
Brief Summary
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...
Detailed Description
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 consecu...
Eligibility Criteria
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.
Key Trial Info
Start Date :
September 1 1992
Trial Type :
OBSERVATIONAL
End Date :
July 1 2003
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00001319
Start Date
September 1 1992
End Date
July 1 2003
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892