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Toll free: 1-800-411-1222
TTY: 1-866-411-1010
Fax: 301-480-9793
Mail: Patient Recruitment—ICICLE Study, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892-2655

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What Is the ICICLE Study?

ICICLE is a research study testing the safety of interleukin 7 (IL-7) in patients with idiopathic CD4 lymphocytopenia (ICL). People with ICL are at risk for serious infections and autoimmune disorders. Right now there is no proven treatment for ICL. Volunteer participation in this study will help NIH researchers learn about the safety of IL-7 taken at different doses and its ability to boost immune response in people with ICL who are at risk for disease progression.

About the Study

What does the study involve?

If you are interested in participating in the study, you will be asked to answer some questions and then come to NIH for a screening visit to make sure you are healthy and able to participate. If you decide to participate in the study, you will be asked to visit NIH 16 times in 48 weeks for dosing and checkups. During the study, you will get six doses of the study drug (rhIL-7). The study drug is given by inserting a needle under your skin.

Where is the study taking place?

The study is being conducted at the Warren Grant Magnuson Clinical Center (Building 10) at NIH in Bethesda, MD, which is accessible by car and public transportation. After you are accepted in the study, you may be reimbursed for your travel expenses.

Who can participate?

You may be able to participate if the following apply to you:

  • You are 18 years of age or older.
  • You are able and want to give blood and tissue samples for testing and storage.
  • You have a CD4 T-cell count less than 300 cells/µL.
  • You are not pregnant, and you are willing to use effective birth control during the study.
  • You have an established primary care provider.

You cannot participate if any of the following apply to you:

  • You have HIV or have ever had hepatitis B or hepatitis C.
  • You take certain blood-thinning medicines (aspirin is allowed).
  • You have a history of cardiovascular disease or a heartbeat that is not normal.
  • You have a blood relative who has died from heart problems.
  • You have had cytotoxic, chemotherapeutic, immunosuppressant (such as systemic steroids), immunomodulatory (such as IL-2, IL-7, interferon-γ), or growth factor therapy within the past six months.
  • You have participated in another investigational intervention study within the last six months.
  • You have had a viral, bacterial, parasitic, or fungal infection that needed hospitalization or systemic treatment, other than long-term maintenance medicines, within 28 days of screening.
  • You are pregnant or breastfeeding.
  • You have had systemic treatment or hospitalization for a serious illness within 56 days (eight weeks) of screening

    Note: If you have completed therapy or have been on therapy for more than four weeks prior to screening, and the study doctor says that you can participate, you may be able to participate in the ICICLE study.

  • You have had a hematologic or lymphoid cancer (such as lymphoma).

How much does it cost?

There is no charge to participate in this research study. All study-related medical care, including clinic visits and procedures, are free.

Will I receive payment of some kind?

Yes, you will be compensated for your participation in the study. Transportation and other expenses may also be covered.

How do I learn more or volunteer?

If you have questions or would like more information, contact Patient Recruitment at the NIH Clinical Center.

Toll free: 1-800-411-1222
TTY: 1-866-411-1010
Fax: 301-480-9793
Mail: Patient Recruitment—ICICLE Study, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892-2655

To learn more about the ICICLE study (trial ID: NCT00839436), visit ClinicalTrials.gov.

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Last Updated June 23, 2010