FilariasisNCT00001230
Host Response to Infection and Treatment in Filarial Diseases
An observational study of Filariasis and Helminthiasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 100 years
- Conditions the study is for
- Filariasis, Helminthiasis, Parasitic Infection
- What is being tested?
- Diethylcarbamazine
- How many people
- 425 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 1991to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age 3-100 years.
- Access to a primary medical care provider outside of the NIH.
- Ability to give informed consent.
- Clinical evidence suggestive of a filarial infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Host Response to Infection and Treatment in the Filarial Diseases of Humans
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.
Read more
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.
- Conditions
- Filariasis, Helminthiasis, Parasitic Infection, Mansonelliasis, Onchocerciasis
- Being tested
- Diethylcarbamazine
- Keywords
- Wuchereria Bancrofti, Loa Loa, Brugia Malayi, Onchocerca Volvulus, Filarial Infection, Natural History
- Medical subject headings
- Filariasis, Helminthiasis, Parasitic Diseases, Mansonelliasis, Onchocerciasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiethylcarbamazineDrug
Diethylcarbamazine is a drug administered under an IND held by the CDC. Standard dosing is used.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients that have, or are suspected of having, one of the filarial infections affecting humans Receives: Drug: Diethylcarbamazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (4)
To identify clinical and biological markers of successful treatment in filarial-infected individuals
Identification of clinical and biological markers of successful treatments
Measured: 10 years
To characterize the immunoregulatory mechanisms at play in filaria-infected individuals
Characterization of immunoregulatory mechanisms
Measured: 10 years
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.
Measured: 10 years
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start15 Mar 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FilariasisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas B Nutman, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001230
- Sponsor's protocol ID
- 880083
- Other IDs
- 88-I-0083
- Status last verified
- 28 Oct 2026
- First submitted
- 3 Nov 1999
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 10530467Showler 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 30761981Herrick 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 25234520Gazzinelli-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 38587077Bennuru 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 37243712Ricciardi 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 32561912Herrick 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Response to Infection and Treatment in the Filarial Diseases of Humans
- ClinicalTrials.gov ID
- NCT00001230
- Acronym / sponsor ID
- 880083
- Conditions
- Filariasis, Helminthiasis, Parasitic Infection, Mansonelliasis, Onchocerciasis
- Keywords
- Wuchereria Bancrofti, Loa Loa, Brugia Malayi, Onchocerca Volvulus, Filarial Infection, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 425 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Mar 1991 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: DiethylcarbamazinePatients that have, or are suspected of having, one of the filarial infections affecting humans |
Who may qualify
- Ages
- 3 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age 3-100 years.
- Access to a primary medical care provider outside of the NIH.
- Ability to give informed consent.
- Clinical evidence suggestive of a filarial infection
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiethylcarbamazineDiethylcarbamazine is a drug administered under an IND held by the CDC. Standard dosing is used. | Drug | 1 |
Primary outcome
Define the determinants of the susceptibility to filarial infection, the development of filarial disease and the beneficial or adverse response to chemotherapy
Time frame: 10 years
Susceptibilities to filarial infection will be determined
4 secondary outcomes
To identify clinical and biological markers of successful treatment in filarial-infected individuals
Time frame: 10 years
To characterize the immunoregulatory mechanisms at play in filaria-infected individuals
Time frame: 10 years
To create a serum and cell bank for the study of filarial infections of humans both before and at fixed times following definitive treatment.
Time frame: 10 years
To understand the natural history of filarial infections in expatriates and other travelers and in immigrant populations
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 10530467Klion 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.
- Background: PubMed 30761981Showler 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.
- Background: PubMed 25234520Herrick 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.
- Derived from this study: PubMed 38587077Gazzinelli-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.
- Derived from this study: PubMed 37243712Bennuru 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.
- Derived from this study: PubMed 32561912Ricciardi 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.
- Derived from this study: PubMed 32055862Herrick 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas B Nutman, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Filariasis and Helminthiasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the determinants of the susceptibility to filarial infection, the development of filarial disease and the beneficial or adverse response to chemotherapy (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001230, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.