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Genetic Susceptibility to Cryptococcal and Other Systemic Fungal Infections in Adults


N/A
18 Years
N/A
Open (Enrolling)
Both
Cryptococcosis, Lymphopenia

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Trial Information

Genetic Susceptibility to Cryptococcal and Other Systemic Fungal Infections in Adults


Cryptococcosis is a fungus which causes infection in immunocompromised patients, such as
those with the acquired immunodeficiency syndrome, but also in occasional persons who have
been previously healthy. The reasons for infection of ostensibly normal persons remain
unclear. Now that enumeration of lymphocyte subpopulations has become more common, a low
number of DC4 cells have been found in some cryptococcosis patients. These patients fit the
CDC definition of idiopathic CD4 Lymphocytopenia (ICL) in that they have CD4 levels below
300/microl, no laboratory evidence of HIV infection and no defined immunodeficiency or
therapy associated with depressed CD4 levels. One of the first five cases of ICL reported
in that issue of MMWR was presented with cryptococcal meningitis. According to Dr. Harold
Jaffe at CDC, about one fourth of the ICL cases reported to CDC by December, 1992 have
presented with cryptococcosis (personal communication.) However the incidence of ICL in
cryptococcosis patients is unknown. Also, the long term outcome of patients with
cryptococcosis and ICL patients is unclear. For example, it is not known if they are more
difficult to cure than other previously normal patients, as would be the case had they been
HIV seropositive.

In addition, novel discovery methods such as genome wide association studies (GWAS) of copy
number variation (CNV) and single nuclear polymorphisms (SNP's) have been used to identify
genes involved in patient diseases. We would thus like to supplement the methods previously
used in this protocol with genetic comparisons, maintaining the original objectives of the
study.

This protocol will bring to NIH patients with cryptococcosis who have no underlying disease,
either with or without prior treatment of their mycosis. Those who have ICL will be
compared with those not having ICL for response to treatment, prior and future opportunistic
infections other than cryptococcosis, and future course of the lymphocyte subpopulations.

Inclusion Criteria


- INCLUSION CRITERIA:

1. Positive culture of Cryptococcus neoformans from any body site;

2. First degree relative (mother, father, sister, brother) of patients with
positive Cryptococcus neoformans from anybody site.

3. Age 18 years or older; and

4. Ability to provide informed consent.

EXCLUSION CRITERIA (Apply to patients only):

1. Known HIV positive serology or other condition predisposing to cryptococcosis,
including but not limited to corticosteroid therapy equivalent to prednisone 20 mg
per day or more or acidosis.

2. Dementia impairing informed consent.

INCLUSION CRITERIA FOR CONTROLS:

1. History of ICL without a history of cryptococcosis or

2. Other conditions which may predispose to cryptococcosis, such as other opportunistic
infections and autoimmune diseases.

EXCLUSION CRITERIA FOR CONTROLS:

1. Iatrogenic immunodeficiency such as concomitant corticosteroid treatment (greater
than an equivalent of 10 mg of prednisone daily for more than 2 weeks), other
immunosuppressive medications, total body irradiation or others

2. Dementia impairing informed consent.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

1. Weight greater than 110 lbs

2. Hemoglobin level greater than 11 g/dl

3. Ages 18-70

EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

1. History of hepatitis B or hepatitis C

2. HIV positivity

3. Any condition which in the opinion of the investigators may alter immune function

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

John E Bennett, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Allergy and Infectious Diseases (NIAID)

Authority:

United States: Federal Government

Study ID:

930106

NCT ID:

NCT00001352

Start Date:

March 1993

Completion Date:

Related Keywords:

  • Cryptococcosis
  • Lymphopenia
  • Cryptococcus Neoformans
  • Cryptococcosis
  • CD4
  • Cryptococcosis
  • Lymphopenia

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892