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Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
09-I-0102 |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Special Instructions |
Currently Not Provided |
Keywords |
Idiopathic Lymphocytopenia; |
Recruitment Keyword(s) |
Idiopathic CD4 Lymphocytopenia |
Condition(s) |
Idiopathic CD4+ lymphocytopenia; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
- Idiopathic CD4+ lymphocytopenia (ICL) is a condition in which there is a decreased level of CD4+ lymphocytes (a type of white blood cell), which can lead to opportunistic infections or autoimmune disorders and diseases.
Objectives:
- To characterize the natural history with regard to CD4+ T cell count and onset of infection, malignancy, and autoimmunity.
- To describe the immunological status of patients affected by ICL while providing the best possible standard therapy to eradicate opportunistic infections.
- To establish the timeline of CD4 lymphocytopenia, with particular focus on defining subgroups of patients according to the decline, stabilization, or rise of CD4+ T cell counts over time.
- To characterize the opportunistic infections that occur in ICL patients at microbiologic and molecular levels.
- To characterize the immunophenotype and possible genetic immunodeficiency causes of ICL.
- To determine whether measurable immunologic parameters correlate with the development of opportunistic infections or other comorbidities such as lymphoma in patients with ICL.
- To determine whether there is any association between ICL and autoimmunity.
- To determine CD4+ T cell turnover, survival, functionality, and cytokine responsiveness in ICL patients.
Eligibility:
- Patients 2 years of age and older with an absolute CD4 count less than 300 in children 6 years or older and adults or less than 20% of T cells in children younger than 6 on two occasions at least 6 weeks apart.
- Patients with negative results of HIV testing by ELISA, Western Blot, and viral load.
- Patients must not have underlying immunodeficiency conditions, be receiving cytotoxic chemotherapy (anti-cancer drugs that kill cells), or have cancer.
Design:
- At the initial visit to the National Institutes of Health, the following evaluations will be conducted:
- Personal and family medical histories.
- Physical examination, including rheumatology evaluation and other consultations as medically indicated (e.g., dermatology, pulmonology, ophthalmology, imaging studies).
- Blood samples for analysis of red and white blood cell counts, liver function, immune hormones, and antibody and autoantibody levels, white blood cell growth and function, and DNA.
- Urinalysis and urine pregnancy testing for female patients of childbearing age.
- Evaluation and treatment of active infections as medically indicated, including biopsies, buccal swabs, pulmonary function tests, and imaging studies.
- Follow-up visits will take place approximately every 12 months or more frequently if indicated, and will continue for a minimum of 4 years and a maximum of 10 years.
- Evaluations at follow-up will include blood samples (i.e., CBC with differential, biochemical profile, HIV testing, etc.) and urinalysis and rheumatology consults.
Eligibility
INCLUSION CRITERIA:
To be eligible for this study, patients must satisfy all of the following inclusion criteria:
- Age greater than or equal to 2 years
- Absolute CD4 count < 300 cells/microL or < 20% of total T cells in children greater than or equal to 6 years old and adults on at least two occasions at least 6 weeks apart; or CD4+ percentage < 20% of normal on 2 occasions at least 6 weeks apart in children < 6 years old
- Ongoing care by a referring primary care physician
- Willingness to allow storage of blood and tissue samples for future analysis
EXCLUSION CRITERIA:
Patients will be ineligible for this study if they satisfy any of the following criteria:
- Known infection with HIV-1, HIV-2, or human T-cell lymphotropic viruses (HTLV-1 or HTLV-2) as demonstrated by ELISA and Western blot and/or viral load testing
- Known underlying immunodeficiency syndrome
- Evidence of active malignancy
- Receipt of medications, herbal substances, or biologic agents known to diminish the CD4+ count within 30 days of when the CD4+ lymphocytopenia was detected
- Any condition that in the judgment of the investigators would place the subject at undue risk or compromise the results of the study.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Kathryn J. Sowerwine, M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health BG 10-CRC RM B3-4141 MSC 1684 10 CENTER DR BETHESDA MD 20892-1684 (917) 603-2013 sowerwinekj@mail.nih.gov |
Pamela A. Welch, R.N. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 12C103 10 Center Drive Bethesda, Maryland 20892 (301) 402-0449 welchp@mail.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00867269
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