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Scientists launch Long-Term study to unravel mysterious immune condition

NCT ID NCT00867269

Knowledge-focused Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 01, 2026 · Updated 15 times

Summary

This study follows 950 people with idiopathic CD4+ lymphocytopenia (ICL), a rare condition where low CD4+ white blood cells raise infection risk. Researchers will track participants for up to 10 years, collecting medical history, blood samples, and infection data. The goal is to understand how ICL progresses and what causes it, without testing any new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal genetic or immune factors behind ICL, pointing toward future treatments.
What could go wrong
This is an observational study, not testing a treatment. It may not lead to direct therapies, and results depend on long-term follow-up.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 950 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2009

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults with idiopathic CD4+ lymphocytopenia (ICL) who have CD4 \<300/microliters or \< 20% of total T cells and their blood relatives and household contacts.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* ICL PARTICPANT INCLUSION CRITERIA: To be eligible for this study, patients must satisfy all of the following inclusion criteria: 1. Age greater than or equal to 18 years 2. Absolute CD4 count \< 300 cells/microL or \< 20% of total T cells on at least two occasions at least 6 weeks apart 3. Ongoing care by a referring primary care physician 4. Willingness to allow storage of blood and tissue samples for future analysis ICL PARTICPANT EXCLUSION CRITERIA: Patients will be ineligible for this study if they satisfy any of the following criteria: 1. Known infection with HIV-1, HIV-2, or human T-cell lymphotropic viruses (HTLV-1 or HTLV-2) as demonstrated by enzyme-linked immunosorbent assay (ELISA) and western blot and/or viral load testing 2. Known underlying immunodeficiency syndrome other than ICL 3. Evidence of active malignancy 4. Receipt of medications, herbal substances, or biologic agents known to diminish the CD4+ count within 30 days of when the CD4+ lymphocytopenia was detected 5. Any condition that in the judgment of the investigators would place the subject at undue risk or compromise the results of the study. BLOOD RELATIVE INCLUSION CRITERIA: To be eligible for study participation as a blood relative, subjects must be greater than or equal to 18 years of age and be a blood relative of an individual who meets or has met the CDC criteria for ICL. HOUSEHOLD CONTACT INCLUSION CRITERIA: To be eligible for study participation as a household contact, subjects must be greater than or equal to18 years of age and live within the same household as an ICL subjects participating in this protocol. Blood relatives who are household contacts are eligible to participate.

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Conditions

The condition(s) this trial relates to.

autoimmune disease common wart Cryptococcal meningitis idiopathic CD4 lymphocytopenia idiopathic CD4-positive T-lymphocytopenia inborn error of immunity Opportunistic Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cryptococcal meningitis Idiopathic CD4+ lymphocytopenia Warts

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.