G-CSF and Plerixafor for Idiopathic CD4 Lymphocytopenia

Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

Recruiting Phase 2 Interventional Study
Idiopathic CD4-Positive T-Lymphocytopenia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
40 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for

This trial is looking for adults who have idiopathic CD4 lymphocytopenia (ICL) or similar immune issues, and healthy volunteers. Participants will receive medication to help collect specific blood cells for research purposes.

Are You a Good Fit for This Trial?
Rules you out Hepatitis BHepatitis CActive drug or alcohol dependence

You may be able to join if

  • I have been diagnosed with idiopathic CD4 lymphocytopenia.
  • I am between 18 and 65 years old.
  • I weigh at least 50 kg but less than 167 kg.
  • I am willing to give informed consent.
  • I understand the study procedures and will attend follow-up visits.
  • I have HIV-1 and HIV-2 negative test results.
  • I have a primary care provider.
  • I agree to have my blood samples stored for future research.

You may not be able to join if

  • I have an active uncontrolled infection.
  • I have current autoimmune conditions needing systemic therapy.
  • I have a history of blood cancers like leukemia.
  • I have severe kidney problems.
  • I have controlled hypertension that is too high.
  • I am currently using lithium.
  • I am pregnant or breastfeeding.
  • I have had a serious allergic reaction to NSAIDs.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
Idiopathic CD4 lymphocytopenia (ICL) is a rare syndrome defined by consistently low CD4 T cell counts (\<300/mm\^3) without evidence of HIV infection or other known immunodeficiency. Patients with ICL are at risk for opportunistic infections typically associated with HIV/AIDS such as disseminated cryptococcal infection and severe human papillomavirus-related dysplasia. More than 20 years since the…
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA ICL patients: 1. Documented history of idiopathic CD4 lymphocytopenia as defined by CD4 T cell count \<300 cells/microL or \<20% of total T lymphocytes on 2 occasions at least 6 weeks apart in the absence of any illness or medications accounting for CD4 lymphocytopenia. Althou…
Contacts

Irini Sereti, M.D.

(301) 496-5533

isereti@niaid.nih.gov

CONTACT