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Trial record 70 of 1171 for:    Sexually Transmitted Diseases | ( Map: United States ) | NIH

Evaluation of HIV-Negative Patients With Low CD4+ T Lymphocyte Counts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001319
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : March 4, 2008
Information provided by:
National Institutes of Health Clinical Center (CC)

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 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:

  • Complete physical examination.
  • Medical history, including questions about sexual contacts, intravenous drug use, travel, blood transfusions, previous illnesses, including sexually transmitted diseases, and health of family members.
  • Urine test.
  • Blood tests for routine and research purposes, including tests for HIV, hepatitis, syphilis and other infections, evaluation of immune function, and culture for viruses in the HIV family. No more than 1 pint of blood will be drawn every 6 weeks.
  • Pregnancy test for women of childbearing potential.
  • Skin tests for tuberculosis and immune function. These tests involve injecting a small amount of the substance to be tested just under the skin and looking for a raised area 1 to 2 days later.
  • Apheresis. Whole blood is collected through an arm vein (similar to donating blood), and circulated through a cell separator machine, where it is spun to separate the components. The red cells are then returned to the patient either through the same needle or through a needle in the other arm, and the plasma and white cells are extracted for study. The procedure, which takes 1 to 2 hours, may be repeated up to 3 times.

Family members will have 60 cc (4 tablespoons) of blood drawn to determine CD4+ T cell counts.

Condition or disease
CD4 Lymphocytopenia Idiopathic CD4 Positive T Lymphocytopenia

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 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.

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Study Type : Observational
Enrollment : 100 participants
Official Title: Evaluation of the Epidemiology, Clinical Manifestations, Etiologies, and Immunology of Human Immunodeficiency Virus (HIV) Negative CD4 T Lymphocyte Deficient Patients
Study Start Date : September 1992
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001319

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United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00001319     History of Changes
Other Study ID Numbers: 920256
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: July 2003
Keywords provided by National Institutes of Health Clinical Center (CC):
HIV Negative
CD4 Deficiency
Additional relevant MeSH terms:
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T-Lymphocytopenia, Idiopathic CD4-Positive
Leukocyte Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases