Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00814827|
Recruitment Status : Active, not recruiting
First Posted : December 25, 2008
Last Update Posted : August 4, 2022
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.
|Condition or disease|
|Non-Tuberculous Mycobacteria Mycobacterium Tuberculosis Opportunistic Infection|
|Study Type :||Observational|
|Actual Enrollment :||224 participants|
|Official Title:||Mycobacterial and Opportunistic Infections in HIV-Negative Patients Associated With Autoantibodies to Interferon-gamma|
|Actual Study Start Date :||December 23, 2008|
Patients with nontuberculous mycobacteria (NTM) alone.
Patients with non-NTM opportunistic infection, either with or without concurrent NTM infection.
Patients with pulmonary mycobacterium tuberculosis (MTB).
Patients with disseminated mycobacterium tuberculosis (MTB).
Blood Specimen Donors.
- 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 0I (groups 1 and 2) versus normal or diseased controls(groups 3 and 5).
- 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 ]Characterization of the natural history and infections of consecutive patients with NTM alone and NTM with other 01. Speciation of the opportunistic infections identified and categorization of these infections with descriptive statistics.
- Identification of predisposing factors for the development of autoimmunity to cytokines and /or their receptors. [ Time Frame: Ongoing ]Identification of predisposing factors for the development of autoimmunity to cytokines and /or their receptors.
- Identification of other autoantibodies that might manifest similarly to patients with autoantibodies to IFNg. [ Time Frame: Ongoing ]Identification of other autoantibodies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814827
|National Taiwan University|
|Principal Investigator:||Christa S Zerbe, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|