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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00814827 |
Purpose
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 |
|---|
|
Immunodeficiency Mycobacterial Infection Opportunistic Infection |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma |
| Estimated Enrollment: | 215 |
| Study Start Date: | December 2008 |
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 suggests 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 215 patients over 3 years as per sample size justification and the groups described.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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):
Group 2 (non-NTM OI with or without NTM):
Group 3 (diseased control with pulmonary MTB):
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.
Group 5 (Blood Specimen Donors):
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 the exclusionary criteria:
EXCLUSION CRITERIA:
Patients will be excluded for the following reasons:
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| Thailand | |
| Srinagarind Hospital | Recruiting |
| Khon Kaen, Thailand, 40002 | |
More Information
| Study ID Numbers: | 999909060, 09-I-N060 |
| Study First Received: | December 24, 2008 |
| Last Updated: | November 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00814827 History of Changes |
| Health Authority: | United States: Federal Government |
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Interferon-Gamma Autoantibodies Mycobacteria Opportunistic Infections Immunodeficiency |
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Bacterial Infections Anti-Infective Agents Communicable Diseases Opportunistic Infections Immunologic Factors Immune System Diseases Interferon Type II Antineoplastic Agents Physiological Effects of Drugs Interferons Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Actinomycetales Infections Virus Diseases Gram-Positive Bacterial Infections Autoantibodies Therapeutic Uses Mycobacterium Infections Parasitic Diseases Interferon-gamma, Recombinant |