Nontuberculous MycobacteriaNCT00814827
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
An observational study of Nontuberculous Mycobacteria and Mycobacterium Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 3 countries.
Trial summary
Opportunistic infections are caused by bacteria, mycobacteria, fungi or viruses that do not normally cause infections in people with healthy immune systems. Some of these infections can cause public health concerns, especially in areas with limited access to treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Nontuberculous Mycobacteria, Mycobacterium Tuberculosis, Opportunistic Infections
- How many people
- 224 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 7 Jan 2010to 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective natural history cohort study with a case-control component. Patients will be recruited from 5 groups: 1) subjects with NTM alone, 2) subjects with a non-NTM OI, either with or without concurrent NTM infection, 3) subjects with pulmonary MTB, 4) subjects with disseminated MTB, and 5) Blood Specimen Donor controls.
Who may be able to join
- Patients must meet all of the following criteria at the time of evaluation to be eligible for enrollment into the study cohorts:
- Group 1 (NTM alone):
- Past or current infection with NTM proven by culture or specific DNA detection in the presence of a compatible clinical picture as judged by the responsible clinician and PI on site.
- NTM is not felt to be iatrogenic (such as indwelling catheter associated or post-operative wound infection)
- HIV negative within 3 months either prior to the diagnosis of OI, or prior to enrollment in this study, if HIV status was unknown at the time of OI
- No evidence of active malignancy
Show all 32Show fewer
- No systemic corticosteroids at time of diagnosis of OI (defined as greater than 4 weeks at a dose greater than 10 mg per day of prednisone within 3 months prior to diagnosis of the NTM)
- No preexisting immune deficiency
- Group 2 (non-NTM OI with or without NTM):
- Patients must have or have had proven infection with one or more of the following organisms: disseminated Salmonella, Listeria, Penicillium, Burkholderia pseudomallei, Cryptococcus, Histoplasma, Herpes zoster involving 2 or more non-contiguous dermatomes, or extradermal involvement or other opportunistic infections not listed above, but relevant, as determined by the PI.
- Patient may have infection with NTM in addition to one or more of the above infection(s).
- HIV-negative within 3 months either prior to the diagnosis of OI, or prior to enrollment in this study, if HIV status was unknown at the time of OI diagnosis
- No evidence of active malignancy
- No systemic corticosteroids at time of diagnosis of OI (defined as greater than 4 weeks at a dose greater than 10 mg per day of prednisone within 3 months prior to diagnosis of the NTM)
- No preexisting immune deficiency
- Group 3 (diseased control with pulmonary MTB):
- Active pulmonary MTB, i.e. patients who have sputum that is either culture positive for MTB or AFB positive and responding to therapy for MTB.
- Diagnosed within the past 6 months.
- No concurrent infections due to NTM or OI listed under above inclusion criteria for study subjects
- No clinical evidence of HIV
- Group 4 (diseased control with disseminated MTB):
- Disseminated MTB includes infections involving greater than or equal to 2 noncontiguous sites, one of which may include pulmonary disease or greater than or equal to 2 separate groups of lymph nodes.
- Active disseminated MTB or cured disseminated MTB
- No concurrent infections due to NTM or OI listed under above inclusion criteria for study subjects
- HIV negative within 3 months either prior to the diagnosis of MTB, or prior to enrollment in this study, if HIV status was unknown at the time of MTB diagnosis
- No evidence of active malignancy
- No systemic corticosteroids at time of diagnosis of OI (defined as > 4 weeks at a dose > 10 mg per day of prednisone within 3 months prior to diagnosis of the NTM)
- No preexisting immune deficiency.
- Group 5 (Blood Specimen Donor):
- Eligibility criteria not applicable. Blood will be collected from volunteers, and no medical evaluation will be performed.
- To be a blood donor the person cannot be excluded per these exclusionary criteria: Patient cannot be less that 18 or more than 85, Patient must not weigh less than 45 KG (99 Lbs), Patient cannot be receiving chemotherapy or have cancer, Patient cannot be receiving any immunosuppressant medications, Patient cannot have a history of heart, lung, kidney disease or bleeding disorder.
- Samples will be collected from anyone of the collaborating sites. Immediately after drawing a specimen it will be assigned a number that is unlinked to the person donating. Thus, they will be anonymous and not traceable back to the original volunteer. Subjects will be consented and compensated for their contribution.
Who cannot join
- Patients will be excluded for the following reasons:
- HIV-positive serostatus for groups 1, 2 and 4 (groups 3 and 5 we will not be routinely performing HIV testing)
- Active malignancy
- Medical conditions requiring immune modulating therapy (i.e. corticosteroids, biological agents, anti-metabolites) and /or chemotherapy
- Any other medical conditions unsuitable for this study as determined by the principal investigator
- Age less than 18 years
- Subjects cannot be receiving any other investigational study agents when enrolling on this study.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Thailand3 sites
National Siriraj Hospital, Mahidol Universtiy
Bangkok
Ramathibodi Hospital, Mahidol Universtiy
Bangkok
Srinagarind Hospital
Khon Kaen, 40002
About this study
Official title: Mycobacterial and Opportunistic Infections in HIV-Negative Patients Associated With Autoantibodies to Interferon-gamma
Opportunistic infections are caused by bacteria, mycobacteria, fungi or viruses that do not normally cause infections in people with healthy immune systems. Some of these infections can cause public health concerns, especially in areas with limited access to treatment. People who acquire opportunistic infections usually have diseases that affect their immune systems, such as human immunodeficiency virus (HIV), or do not have enough white blood cells to fight the infection. However, some people acquire opportunistic infections even though they have normal amounts of white blood cells and are free from known diseases that harm their immune systems. This study will investigate some of the reasons that otherwise healthy people get opportunistic infections to learn more about why some people are more likely to have them.
This study will include up to 210 HIV-negative males and females older than 18 years of age who have opportunistic infections. The patients will be drawn from multiple sites in Thailand and Taiwan including Khon Kaen University Hospital, Siriraj Hospital, Ramathibodi Hospital, National Taiwan University Hospital, National Cheng-Kung University Hospital
Read more
Patients will undergo an initial evaluation that will include a physical examination, medical history, and blood and urine testing. Additional tests will be conducted if the researchers consider that the tests are medically necessary to treat the opportunistic infection; the results of the tests will be reviewed and saved for study purposes. Depending on the severity of the infection, the initial evaluation may take more than 1 day to complete.
After the evaluation, patients will be given standard and appropriate medicines to treat the infections.
Patients will return for follow-up visits to allow researchers to monitor their condition and to assess how well the patient is responding to the treatment. Patients will be evaluated by the study researchers at least once a year for 2 years following the initial treatment.
Read the detailed description
The acquisition of opportunistic infections has been causally linked to innate and acquired immunodeficiencies. We have recently identified a population of Asian women with autoantibodies to interferon gamma (IFNg), all of whom were diagnosed by virtue of nontuberculous mycobacterial infections. Similar patient populations have been reported from Thailand and Taiwan, and we have found similar autoantibodies in anonymous serum samples from there. In addition, many of the patients who have disseminated or lymphatic nontuberculous infections have had other opportunistic infections (OI), such as salmonella, penicilliosis, and histoplasmosis. Recently, patients who are clinically similar to our Thai population were described in Taiwan. Two of these cases have been diagnosed with IFNg autoantibodies (unpublished data). The described patients have normal lymphocyte counts and are human immunodeficiency virus (HIV) negative. Therefore, the identification of autoantibodies to a critical cytokine, the occurrence of opportunistic infections, and the lack of other common explanations suggest that this is an important population to study. We propose to enroll patients in a natural history study of non-HIV opportunistic infections to explore the presence of autoantibodies to cytokines, and to examine potential immunogenetic factors influencing the development of this disease. Plasma, cells, and DNA samples will be obtained and stored for use in this study. This study will accrue up to 265 patients over 5 years as per the protocol with follow up for 20 years on each patient, sample size justification and the groups described in the protocol.
- Keywords
- Interferon-Gamma, Autoantibodies, Disseminated Infection, Pulmonary Infection, Blood Donor, Natural History
- Medical subject headings
- Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with nontuberculous mycobacteria (NTM) alone. | |
| Group 2 | Patients with non-NTM opportunistic infection, either with or without concurrent NTM infection. | |
| Group 3 | Patients with pulmonary mycobacterium tuberculosis (MTB). | |
| Group 4 | Patients with disseminated mycobacterium tuberculosis (MTB). | |
| Group 5 | Blood Specimen Donors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the presence of autoantibodies to IFNy in HIV-negative Thai and Taiwanese patients with disseminated NTM and OI who are followed at the participating institutions.
Compare the baseline prevalence rate of autoantibodies to IFNg, as defined by having >75% inhibition, in patients with disseminated NTM or other OI (groups 1 and 2) versus normal or diseased controls (groups 3 and 5).
Measured: ongoing
Secondary outcomes (3)
Identification of predisposing factors for the development of autoimmunity to cytokines and/or their receptors.
Identification of predisposing factors for the development of autoimmunity to cytokines and/or their receptors.
Measured: ongoing
Identification of other autoantibodies that might manifest similarly to patients with autoantibodies to IFNg.
Identification of other autoantibodies.
Measured: ongoing
Characterization of the natural history and specific microbiology in HIV-negative patients with disseminated NTM and other OI and to determine any statistically significant differences from MTB controls or healthy blood bank donors.
Characterization of the natural history and infections of consecutive patients with NTM alone and NTM with other OI. Speciation of the opportunistic infections identified and categorization of these infections with descriptive statistics.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study start7 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nontuberculous MycobacteriaStudies 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
- 224 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christa S Zerbe, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814827
- Sponsor's protocol ID
- 999909060
- Other IDs
- 09-I-N060
- Status last verified
- 30 Jun 2026
- First submitted
- 24 Dec 2008
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share human data generated in this study for future research as follows:@@@@@@@@@@@@ (Summation)Identified data in the Biomedical Translational Research Information System (BTRIS, automatic for activities in the NIH CC).@@@@@@@@@@@@ (Summation)De-identified or identified data with approved outside collaborators under appropriate agreements.@@@@@@@@@@@@ (Summation)Data sharing may be complicated or limited in certain cases by contractual obligations or agreements with outside collaborators, such as cooperative research and development agreements, clinical trial agreements, other restraints, etc.
Publications
Dorman SE, Holland SM. Interferon-gamma and interleukin-12 pathway defects and human disease. Cytokine Growth Factor Rev. 2000 Dec;11(4):321-33. doi: 10.1016/s1359-6101(00)00010-1.
PubMed 10959079Patel SY, Ding L, Brown MR, Lantz L, Gay T, Cohen S, Martyak LA, Kubak B, Holland SM. Anti-IFN-gamma autoantibodies in disseminated nontuberculous mycobacterial infections. J Immunol. 2005 Oct 1;175(7):4769-76. doi: 10.4049/jimmunol.175.7.4769.
PubMed 16177125Kampmann B, Hemingway C, Stephens A, Davidson R, Goodsall A, Anderson S, Nicol M, Scholvinck E, Relman D, Waddell S, Langford P, Sheehan B, Semple L, Wilkinson KA, Wilkinson RJ, Ress S, Hibberd M, Levin M. Acquired predisposition to mycobacterial disease due to autoantibodies to IFN-gamma. J Clin Invest. 2005 Sep;115(9):2480-8. doi: 10.1172/JCI19316. Epub 2005 Aug 25.
PubMed 16127458Browne SK, Burbelo PD, Chetchotisakd P, Suputtamongkol Y, Kiertiburanakul S, Shaw PA, Kirk JL, Jutivorakool K, Zaman R, Ding L, Hsu AP, Patel SY, Olivier KN, Lulitanond V, Mootsikapun P, Anunnatsiri S, Angkasekwinai N, Sathapatayavongs B, Hsueh PR, Shieh CC, Brown MR, Thongnoppakhun W, Claypool R, Sampaio EP, Thepthai C, Waywa D, Dacombe C, Reizes Y, Zelazny AM, Saleeb P, Rosen LB, Mo A, Iadarola M, Holland SM. Adult-onset immunodeficiency in Thailand and Taiwan. N Engl J Med. 2012 Aug 23;367(8):725-34. doi: 10.1056/NEJMoa1111160.
PubMed 22913682
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycobacterial and Opportunistic Infections in HIV-Negative Patients Associated With Autoantibodies to Interferon-gamma
- ClinicalTrials.gov ID
- NCT00814827
- Acronym / sponsor ID
- 999909060
- Keywords
- Interferon-Gamma, Autoantibodies, Disseminated Infection, Pulmonary Infection, Blood Donor, Natural History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 224 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 7 Jan 2010 (actual)
- First posted
- 25 Dec 2008 (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.
Opportunistic infections are caused by bacteria, mycobacteria, fungi or viruses that do not normally cause infections in people with healthy immune systems. Some of these infections can cause public health concerns, especially in areas with limited access to treatment. People who acquire opportunistic infections usually have diseases that affect their immune systems, such as human immunodeficiency virus (HIV), or do not have enough white blood cells to fight the infection. However, some people acquire opportunistic infections even though they have normal amounts of white blood cells and are free from known diseases that harm their immune systems. This study will investigate some of the reasons that otherwise healthy people get opportunistic infections to learn more about why some people are more likely to have them.
This study will include up to 210 HIV-negative males and females older than 18 years of age who have opportunistic infections. The patients will be drawn from multiple sites in Thailand and Taiwan including Khon Kaen University Hospital, Siriraj Hospital, Ramathibodi Hospital, National Taiwan University Hospital, National Cheng-Kung University Hospital
Patients will undergo an initial evaluation that will include a physical examination, medical history, and blood and urine testing. Additional tests will be conducted if the researchers consider that the tests are medically necessary to treat the opportunistic infection; the results of the tests will be reviewed and saved for study purposes. Depending on the severity of the infection, the initial evaluation may take more than 1 day to complete.
After the evaluation, patients will be given standard and appropriate medicines to treat the infections.
Patients will return for follow-up visits to allow researchers to monitor their condition and to assess how well the patient is responding to the treatment. Patients will be evaluated by the study researchers at least once a year for 2 years following the initial treatment.
Detailed description
The acquisition of opportunistic infections has been causally linked to innate and acquired immunodeficiencies. We have recently identified a population of Asian women with autoantibodies to interferon gamma (IFNg), all of whom were diagnosed by virtue of nontuberculous mycobacterial infections. Similar patient populations have been reported from Thailand and Taiwan, and we have found similar autoantibodies in anonymous serum samples from there. In addition, many of the patients who have disseminated or lymphatic nontuberculous infections have had other opportunistic infections (OI), such as salmonella, penicilliosis, and histoplasmosis. Recently, patients who are clinically similar to our Thai population were described in Taiwan. Two of these cases have been diagnosed with IFNg autoantibodies (unpublished data). The described patients have normal lymphocyte counts and are human immunodeficiency virus (HIV) negative. Therefore, the identification of autoantibodies to a critical cytokine, the occurrence of opportunistic infections, and the lack of other common explanations suggest that this is an important population to study. We propose to enroll patients in a natural history study of non-HIV opportunistic infections to explore the presence of autoantibodies to cytokines, and to examine potential immunogenetic factors influencing the development of this disease. Plasma, cells, and DNA samples will be obtained and stored for use in this study. This study will accrue up to 265 patients over 5 years as per the protocol with follow up for 20 years on each patient, sample size justification and the groups described in the protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with nontuberculous mycobacteria (NTM) alone. |
| Group 2 | – | –Patients with non-NTM opportunistic infection, either with or without concurrent NTM infection. |
| Group 3 | – | –Patients with pulmonary mycobacterium tuberculosis (MTB). |
| Group 4 | – | –Patients with disseminated mycobacterium tuberculosis (MTB). |
| Group 5 | – | –Blood Specimen Donors. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective natural history cohort study with a case-control component. Patients will be recruited from 5 groups: 1) subjects with NTM alone, 2) subjects with a non-NTM OI, either with or without concurrent NTM infection, 3) subjects with pulmonary MTB, 4) subjects with disseminated MTB, and 5) Blood Specimen Donor controls.
Key inclusion criteria (32 listed)
- Patients must meet all of the following criteria at the time of evaluation to be eligible for enrollment into the study cohorts:
- Past or current infection with NTM proven by culture or specific DNA detection in the presence of a compatible clinical picture as judged by the responsible clinician and PI on site.
- NTM is not felt to be iatrogenic (such as indwelling catheter associated or post-operative wound infection)
- HIV negative within 3 months either prior to the diagnosis of OI, or prior to enrollment in this study, if HIV status was unknown at the time of OI
- No evidence of active malignancy
Key exclusion criteria (7 listed)
- HIV-positive serostatus for groups 1, 2 and 4 (groups 3 and 5 we will not be routinely performing HIV testing)
- Active malignancy
- Medical conditions requiring immune modulating therapy (i.e. corticosteroids, biological agents, anti-metabolites) and /or chemotherapy
- Any other medical conditions unsuitable for this study as determined by the principal investigator
- Age less than 18 years
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
Identification of the presence of autoantibodies to IFNy in HIV-negative Thai and Taiwanese patients with disseminated NTM and OI who are followed at the participating institutions.
Time frame: ongoing
Compare the baseline prevalence rate of autoantibodies to IFNg, as defined by having >75% inhibition, in patients with disseminated NTM or other OI (groups 1 and 2) versus normal or diseased controls (groups 3 and 5).
3 secondary outcomes
Identification of predisposing factors for the development of autoimmunity to cytokines and/or their receptors.
Time frame: ongoing
Identification of other autoantibodies that might manifest similarly to patients with autoantibodies to IFNg.
Time frame: ongoing
Characterization of the natural history and specific microbiology in HIV-negative patients with disseminated NTM and other OI and to determine any statistically significant differences from MTB controls or healthy blood bank donors.
Time frame: ongoing
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 29 Oct 2026.
- Background: PubMed 10959079Dorman SE, Holland SM. Interferon-gamma and interleukin-12 pathway defects and human disease. Cytokine Growth Factor Rev. 2000 Dec;11(4):321-33. doi: 10.1016/s1359-6101(00)00010-1.
- Background: PubMed 16177125Patel SY, Ding L, Brown MR, Lantz L, Gay T, Cohen S, Martyak LA, Kubak B, Holland SM. Anti-IFN-gamma autoantibodies in disseminated nontuberculous mycobacterial infections. J Immunol. 2005 Oct 1;175(7):4769-76. doi: 10.4049/jimmunol.175.7.4769.
- Background: PubMed 16127458Kampmann B, Hemingway C, Stephens A, Davidson R, Goodsall A, Anderson S, Nicol M, Scholvinck E, Relman D, Waddell S, Langford P, Sheehan B, Semple L, Wilkinson KA, Wilkinson RJ, Ress S, Hibberd M, Levin M. Acquired predisposition to mycobacterial disease due to autoantibodies to IFN-gamma. J Clin Invest. 2005 Sep;115(9):2480-8. doi: 10.1172/JCI19316. Epub 2005 Aug 25.
- Derived from this study: PubMed 22913682Browne SK, Burbelo PD, Chetchotisakd P, Suputtamongkol Y, Kiertiburanakul S, Shaw PA, Kirk JL, Jutivorakool K, Zaman R, Ding L, Hsu AP, Patel SY, Olivier KN, Lulitanond V, Mootsikapun P, Anunnatsiri S, Angkasekwinai N, Sathapatayavongs B, Hsueh PR, Shieh CC, Brown MR, Thongnoppakhun W, Claypool R, Sampaio EP, Thepthai C, Waywa D, Dacombe C, Reizes Y, Zelazny AM, Saleeb P, Rosen LB, Mo A, Iadarola M, Holland SM. Adult-onset immunodeficiency in Thailand and Taiwan. N Engl J Med. 2012 Aug 23;367(8):725-34. doi: 10.1056/NEJMoa1111160.
- Individual participant dataSharing planned: Yes. We will share human data generated in this study for future research as follows:@@@@@@@@@@@@ (Summation)Identified data in the Biomedical Translational Research Information System (BTRIS, automatic for activities in the NIH CC).@@@@@@@@@@@@ (Summation)De-identified or identified data with approved outside collaborators under appropriate agreements.@@@@@@@@@@@@ (Summation)Data sharing may be complicated or limited in certain cases by contractual obligations or agreements with outside collaborators, such as cooperative research and development agreements, clinical trial agreements, other restraints, etc.
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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.
Christa S Zerbe, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nontuberculous Mycobacteria and Mycobacterium Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 3 countries.
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 32 inclusion and 7 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 29 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 5 sites in Thailand, China, Taiwan. 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?
Identification of the presence of autoantibodies to IFNy in HIV-negative Thai and Taiwanese patients with disseminated NTM and OI who are followed at the participating institutions. (time frame: ongoing). 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 NCT00814827, which also lists 4 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 29 Oct 2026.