ClinicalTrials.gg
Active, not recruitingNCT00001230Updated Oct 30, 2026

Host Response to Infection and Treatment in Filarial Diseases

An observational study in Filariasis, Helminthiasis and Parasitic Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Active, not recruiting at 1 site in United States. Open to participants aged 3 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Primary conditionOnchocerciasisRegistry: FilariasisReclassifiedWhy we changed it
Registry
Filariasis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Onchocerciasis
Why
  1. The study's listed conditions name Onchocerciasis, a narrower term within Filariasis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Updated Oct 30, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
425
Ages
3 Years to 100 Years
Sex
All
01

Study summary

This study will evaluate and treat patients with filarial infections to explore in depth the immunology of the disease, including susceptibility to infection, disease development, and response to treatment. Filarial infections are caused by parasitic worms. The immature worm (larva) is transmitted to a person through a mosquito bite and grows in the human body to 2 to 4 inches in length. Although many of these infections do not produce symptoms, especially in the early stages of infection, others can have serious consequences, including swelling of the limbs or genitalia, allergic-lung problems, skin rash, eye inflammation that can lead to blindness, and heart disease. This protocol does not involve any experimental diagnostic procedures or treatments, and will use only procedures employed in the standard practice of medicine.

Persons between 3 and 100 years of age diagnosed with or suspected of infection with Wuchereria bancrofti, Bugia malayi, Onchocerca volvulus, Loa loa, or other parasitic worms may be eligible for this study.

Participants will have routine tests to determine the specific type of filarial infection. These may include special tests of the lungs, skin or heart, depending on the type of parasite suspected. Patients with skin reactions may have a "punch biopsy" to examine a small piece of affected skin. For this procedure, an area of skin is numbed with an anesthetic and a small circular area, about 1/3-inch in diameter and 1/2-inch thick, is removed using a sharp cookie cutter-type instrument. Some patients may require bronchoalveolar lavage. For this procedure, the mouth and throat are numbed with lidocaine jelly and spray and, if needed, a sedative is given for comfort. A small plastic tube is placed in a vein to give medications. A pencil-thin tube is then passed through the nose or mouth into the lung airways to examine the airways. Salt water is injected through the bronchoscope into the air passage, acting as a rinse. A sample of the fluid is then withdrawn and examined for infection, inflammatory cells and inflammatory chemicals. (Bronchoalveolar lavage is done only if medically necessary and only on patients 21 years or older.) Once the diagnosis is established, standard treatment will be instituted with either diethylcarbamazine or ivermectin, depending on the type of infection.

Additional procedures for research purposes include:

  • Extra blood draws to study immune cells and other immune substances. (This is the only research procedure that will be done in - More frequent and extensive follow-up evaluations than usual for routine care. They will include physical examination and blood studies.
  • Urine collections at specified periods, possibly including 24-hour collections.
  • Skin tests to examine the body s reaction to allergens-common environmental substances, such as cat dander or pollen-that cause an allergic reaction. The test is done in one of two ways: either the skin is lightly scratched and an allergen extract is placed over the just-broken skin, or a very fine needle is used to inject a small amount of allergen under the skin. In both methods, the site is monitored for swelling or hives in the next 48 hours.
  • Leukapheresis (only on patients 21 or older ) to collect quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.
Read the detailed description

Patients admitted on this protocol will have, or be suspected of having, one of the filarial infections affecting humans. After routine clinical evaluation they will be studied in depth immunologically, and their blood cells and/or serum will be collected to provide reagents (eg., specific antibodies, T-cell clones, etc.) that will be used in the laboratory to address the broader questions of diagnosis, immunoregulation, pathology and immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. It is anticipated both that the patients will receive optimal clinical care for their infections and that the specimens collected from them will prove to be valuable reagents for the laboratory studies of the immunologic responses unique to filarial or other related helminth infections.

02

Conditions studied

  • Filariasis
  • Helminthiasis
  • Parasitic Infection
  • Mansonelliasis
  • Onchocerciasis

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Keywords

  • Wuchereria Bancrofti
  • Loa Loa
  • Brugia Malayi
  • Onchocerca Volvulus
  • Filarial Infection
  • Natural History
03

In context

Onchocerciasis Reclassified

35 studies on the registry are indexed under Onchocerciasis; 7 are open to participants now.

Browse Onchocerciasis studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Compared within Onchocerciasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Filariasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
3 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Males and females having or suspected of having a filarial infections will be enrolled. The participants will either have been native residents of endemic regions where these filarial infections are prevalent or they would have acquired the infection while traveling to such regions.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age 3-100 years.

Access to a primary medical care provider outside of the NIH.

Ability to give .

Clinical evidence suggestive of a filarial infection

Exclusion criteria

EXCLUSION CRITERIA:

Although pregnant or nursing women can be enrolled, they will be excluded from receiving treatment while pregnant or breastfeeding

Less than 3 year of age; greater than 100 years of age

Any condition that the investigator feels put the subject at unacceptable risk for participation in the study

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
425 participants (actual)

Groups and cohorts

  • 1

    Patients that have, or are suspected of having, one of the filarial infections affecting humans

    Drug: Diethylcarbamazine

Interventions

  • Diethylcarbamazine is a drug administered under an IND held by the CDC. Standard dosing is used.

06

What researchers measure

Primary outcomes

  1. Define the determinants of the susceptibility to filarial infection, the development of filarial disease and the beneficial or adverse response to chemotherapy

    Susceptibilities to filarial infection will be determined

    Time frame: 10 years

Secondary outcomes

  1. To identify clinical and biological markers of successful treatment in filarial-infected individuals

    Identification of clinical and biological markers of successful treatments

    Time frame: 10 years

  2. To characterize the immunoregulatory mechanisms at play in filaria-infected individuals

    Characterization of immunoregulatory mechanisms

    Time frame: 10 years

  3. To create a serum and cell bank for the study of filarial infections of humans both before and at fixed times following definitive treatment.

    Cell and serum bank will be maintained.

    Time frame: 10 years

  4. To understand the natural history of filarial infections in expatriates and other travelers and in immigrant populations

    Better understanding of natural history of infections in expatriates and travels

    Time frame: 10 years

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Klion AD, Horton J, Nutman TB. Albendazole therapy for loiasis refractory to diethylcarbamazine treatment. Clin Infect Dis. 1999 Sep;29(3):680-2. doi: 10.1086/598654. PubMed 10530467 ↗
  • Showler AJ, Kubofcik J, Ricciardi A, Nutman TB. Differences in the Clinical and Laboratory Features of Imported Onchocerciasis in Endemic Individuals and Temporary Residents. Am J Trop Med Hyg. 2019 May;100(5):1216-1222. doi: 10.4269/ajtmh.18-0757. PubMed 30761981 ↗
  • Herrick JA, Metenou S, Makiya MA, Taylar-Williams CA, Law MA, Klion AD, Nutman TB. Eosinophil-associated processes underlie differences in clinical presentation of loiasis between temporary residents and those indigenous to Loa-endemic areas. Clin Infect Dis. 2015 Jan 1;60(1):55-63. doi: 10.1093/cid/ciu723. Epub 2014 Sep 18. PubMed 25234520 ↗
  • Gazzinelli-Guimaraes PH, Dulek B, Swanson P, Lack J, Roederer M, Nutman TB. Single-cell molecular signature of pathogenic T helper subsets in type 2-associated disorders in humans. JCI Insight. 2024 Apr 8;9(7):e177720. doi: 10.1172/jci.insight.177720. PubMed 38587077 ↗
  • Bennuru S, Kodua F, Drame PM, Dahlstrom E, Nutman TB. A Novel, Highly Sensitive Nucleic Acid Amplification Test Assay for the Diagnosis of Loiasis and its Use for Detection of Circulating Cell-Free DNA. J Infect Dis. 2023 Oct 3;228(7):936-943. doi: 10.1093/infdis/jiad186. PubMed 37243712 ↗
  • Ricciardi A, Nutman TB. IL-10 and Its Related Superfamily Members IL-19 and IL-24 Provide Parallel/Redundant Immune-Modulation in Loa loa Infection. J Infect Dis. 2021 Feb 3;223(2):297-305. doi: 10.1093/infdis/jiaa347. PubMed 32561912 ↗
  • Herrick JA, Makiya MA, Holland-Thomas N, Klion AD, Nutman TB. Infection-associated Immune Perturbations Resolve 1 Year Following Treatment for Loa loa. Clin Infect Dis. 2021 Mar 1;72(5):789-796. doi: 10.1093/cid/ciaa137. PubMed 32055862 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026

Started Mar 1991 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Nov 4, 1999
StartActual
Mar 15, 1991
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 30, 2026
Enrollment
500 (estimated)→425 (actual)
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Recruiting→Active, not recruiting
    Enrollment 500 (estimated)→425 (actual)
    + 4 other changes: verification date, contact details, site details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001230
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Mar 15, 1991
Last update
Oct 30, 2026

Study contacts

Thomas B Nutman, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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