Evaluation of HIV-Negative Patients With Low CD4+ T Lymphocyte Counts
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||September 1992|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001319 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of HIV-Negative Patients With Low CD4+ T Lymphocyte Counts|
|Official Title ICMJE||Evaluation of the Epidemiology, Clinical Manifestations, Etiologies, and Immunology of Human Immunodeficiency Virus (HIV) Negative CD4 T Lymphocyte Deficient Patients|
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||July 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001319|
|Other Study ID Numbers ICMJE||920256, 92-I-0256|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP