HIV InfectionNCT00001245
Study of Patients With Strongyloides Stercoralis Infection
An observational study of HIV Infection and Nematode Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will explore faster and easier ways to detect infection with the intestinal parasite Strongyloides stercoralis and learn more about the conditions under which it causes serious disease. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- HIV Infection, Nematode Infection, Strongyloidiasis
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1989to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age of 5 to 80 years and of either sex.
- Access to primary medical care provider outside of the NIH
- Ability to give written informed consent (for adults) and parental consent (for those under 18)
- Presence of known or suspected infection with Stronglyloides stercoralis, such as significant peripheral blood eosinophilia (greater than 1000 eosinophils/mm(3)) for which no other cause is apparent.
- Willingness to participate and provide blood for in vitro assays and serum storage.
Who cannot join
- Less than 5 years of age
- Pregnancy is not a criterion for exclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Study of Patients With Known or Suspected Infection With Strongyloides Stercoralis
This study will explore faster and easier ways to detect infection with the intestinal parasite Strongyloides stercoralis and learn more about the conditions under which it causes serious disease. Ordinarily, the Strongyloides helminth (type of intestinal worm) causes only few, if any, symptoms, but in people with weakened immunity it may be very serious, and even deadly.
People between 5 and 80 years of age with known or suspected S. stercoralis infection, or infection with another helminth, such as filariasis, that might cause a cross-reaction with S. stercoralis may be eligible for this study.
Read more
Participants found to be infected with S. stercoralis will be treated with ivermectin, thiabendazole, or albendazole. In addition, they will undergo the following tests and procedures:
- Blood tests and stool samples: Samples will be collected before and after treatment to check general health status and immune function, and to look for parasites in stool. Up to 50 milliliters (10 teaspoons) of blood will be drawn in adults and up to 25 ml (5 teaspoons) in children.
- Skin tests: A test similar to those used for tuberculosis and allergies will be conducted to determine if there is sensitization to products of the parasite. Such a test might be used as a rapid method to diagnose the infection. About three drops of several different antigens (proteins) are injected into the skin of the arm. After 15 to 20 minutes, the area is checked to see if a red spot has formed and, if so, the spot is measured.
Read the detailed description
This study is directed to patients with known or suspected Strongyloides stercoralis infection because it is a relatively common parasitic infection, even in the United States. It is difficult to diagnose, and efficacy of treatment is difficult to evaluate. Some infected individuals can develop serious even fatal, disease under certain conditions of immunosuppression. Because newer diagnostic methods are needed to diagnose this infection, we have developed new diagnostics that will be evaluated in comparison to more standard diagnostic tests. Serum and cells will also be collected from patients on this protocol to understand the cellular and humoral response to the parasite and its antigens. All subjects proven to have Strongyloides stercoralis infection will be treated with standard therapy and followed to assess both the efficacy of treatment and the changes in humoral and cellular immune responses induced by treatment.
- Conditions
- HIV Infection, Nematode Infection, Strongyloidiasis
- Keywords
- Strongyloidiasis, Immediate Hypersensitivity Skin Test, IgE, Nematode, Immunosuppression, Skin Test, Diagnosis, Intestinal Helminth, Immediate Hypersensitivity
- Medical subject headings
- HIV Infections, Nematode Infections, Strongyloidiasis, Enterobiasis, Disease, Hypersensitivity, Immediate
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 startAug 1989
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Enrolment
- 650 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001245
- Sponsor's protocol ID
- 890174
- Other IDs
- 89-I-0174
- Status last verified
- May 2009
- First submitted
- 3 Nov 1999
- Last updated
- 25 Aug 2009
- Results posted
- No
Publications
Neva FA. Biology and immunology of human strongyloidiasis. J Infect Dis. 1986 Mar;153(3):397-406. doi: 10.1093/infdis/153.3.397.
PubMed 3081656Newton RC, Limpuangthip P, Greenberg S, Gam A, Neva FA. Strongyloides stercoralis hyperinfection in a carrier of HTLV-I virus with evidence of selective immunosuppression. Am J Med. 1992 Feb;92(2):202-8. doi: 10.1016/0002-9343(92)90113-p.
PubMed 1543206Sato Y, Otsuru M, Takara M, Shiroma Y. Intradermal reactions in strongyloidiasis. Int J Parasitol. 1986 Feb;16(1):87-91. doi: 10.1016/0020-7519(86)90070-6. No abstract available.
PubMed 3699981
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Patients With Known or Suspected Infection With Strongyloides Stercoralis
- ClinicalTrials.gov ID
- NCT00001245
- Acronym / sponsor ID
- 890174
- Conditions
- HIV Infection, Nematode Infection, Strongyloidiasis
- Keywords
- Strongyloidiasis, Immediate Hypersensitivity Skin Test, IgE, Nematode, Immunosuppression, Skin Test, Diagnosis, Intestinal Helminth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 1989
- Primary completion
- May 2009 (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 explore faster and easier ways to detect infection with the intestinal parasite Strongyloides stercoralis and learn more about the conditions under which it causes serious disease. Ordinarily, the Strongyloides helminth (type of intestinal worm) causes only few, if any, symptoms, but in people with weakened immunity it may be very serious, and even deadly.
People between 5 and 80 years of age with known or suspected S. stercoralis infection, or infection with another helminth, such as filariasis, that might cause a cross-reaction with S. stercoralis may be eligible for this study.
Participants found to be infected with S. stercoralis will be treated with ivermectin, thiabendazole, or albendazole. In addition, they will undergo the following tests and procedures:
- Blood tests and stool samples: Samples will be collected before and after treatment to check general health status and immune function, and to look for parasites in stool. Up to 50 milliliters (10 teaspoons) of blood will be drawn in adults and up to 25 ml (5 teaspoons) in children.
- Skin tests: A test similar to those used for tuberculosis and allergies will be conducted to determine if there is sensitization to products of the parasite. Such a test might be used as a rapid method to diagnose the infection. About three drops of several different antigens (proteins) are injected into the skin of the arm. After 15 to 20 minutes, the area is checked to see if a red spot has formed and, if so, the spot is measured.
Detailed description
This study is directed to patients with known or suspected Strongyloides stercoralis infection because it is a relatively common parasitic infection, even in the United States. It is difficult to diagnose, and efficacy of treatment is difficult to evaluate. Some infected individuals can develop serious even fatal, disease under certain conditions of immunosuppression. Because newer diagnostic methods are needed to diagnose this infection, we have developed new diagnostics that will be evaluated in comparison to more standard diagnostic tests. Serum and cells will also be collected from patients on this protocol to understand the cellular and humoral response to the parasite and its antigens. All subjects proven to have Strongyloides stercoralis infection will be treated with standard therapy and followed to assess both the efficacy of treatment and the changes in humoral and cellular immune responses induced by treatment.
Study design
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 5 to 80 years and of either sex.
- Access to primary medical care provider outside of the NIH
- Ability to give written informed consent (for adults) and parental consent (for those under 18)
- Presence of known or suspected infection with Stronglyloides stercoralis, such as significant peripheral blood eosinophilia (greater than 1000 eosinophils/mm(3)) for which no other cause is apparent.
- Willingness to participate and provide blood for in vitro assays and serum storage.
Key exclusion criteria (2 listed)
- Less than 5 years of age
- Pregnancy is not a criterion for exclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Background: PubMed 3081656Neva FA. Biology and immunology of human strongyloidiasis. J Infect Dis. 1986 Mar;153(3):397-406. doi: 10.1093/infdis/153.3.397.
- Background: PubMed 1543206Newton RC, Limpuangthip P, Greenberg S, Gam A, Neva FA. Strongyloides stercoralis hyperinfection in a carrier of HTLV-I virus with evidence of selective immunosuppression. Am J Med. 1992 Feb;92(2):202-8. doi: 10.1016/0002-9343(92)90113-p.
- Background: PubMed 3699981Sato Y, Otsuru M, Takara M, Shiroma Y. Intradermal reactions in strongyloidiasis. Int J Parasitol. 1986 Feb;16(1):87-91. doi: 10.1016/0020-7519(86)90070-6. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 HIV Infection and Nematode Infection, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 25 Aug 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001245, which also lists 3 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 25 Aug 2009.