NIH Clinical Research Studies

Protocol Number: 94-DK-0127

Active Accrual, Protocols Recruiting New Patients

Title:
Pathogenesis of Focal Segmental Glomerulosclerosis
Number:
94-DK-0127
Summary:
Focal Segmental Glomerulosclerosis (FSGS) is a disease of the kidney. Presently, the cause of FSGS is unknown. However, some researchers believe that the disease may be caused by an infection, possibly a virus. The reasons for thinking this is that a form of FSGS has been associated with certain viral infections such as Human Immunodeficiency Virus (HIV).

Study participation involves giving blood and urine samples. In addition, researchers will study previous biopsy results. All samples will undergo extensive genetic tests to determine if a virus or viral infection exists.

Sponsoring Institute:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
EFFECTS OF GROWTH HORMONE THERAPY ON BODY COMPOSITION AND LIPID KINETICS IN SUBJECTS WITH HIV LIPODYSTROPHY SYNDROME:

INCLUSION CRITERIA:

HIV-seropositive patients with a clinical diagnosis of lipodystrophy (N=10)

Adults greater than or equal to 18 yr

EXCLUSION CRITERIA:

Prior history of diabetes

Hypothyroidism, hyperthyroidism

Hypercortisolism

Hypogonadism

Concomittant acute or chronic illness

Concurrent treatment with medications known to interfere with insulin secretion or action

Concurrent treatment with lipid lowering agents

Transaminasemia greater than or equal to 2X upper limits of normal

Creatinine clearance less than 50 ml/min

History of pancreatitis associated with hypertriglyceridemia

History of cancer, acromegaly, or pituitary tumor

History of cardiovascular disease (myocardial infarction, cerebrovascular accident, angina)

PATHOGENESIS OF HIV-ASSOCIATED LIPODYSTROPHY SYNDROME: ROLE OF HIV VIRAL PROTEINS:

INCLUSION CRITERIA:

HIV-1 seropositive patients (N=10) and healthy, HIV seronegative volunteers (N=10)

Adults greater than 18 yr

EXCLUSION CRITERIA:

Treatment with glucocorticoids for greater than 2 weeks during the preceding 6 months

Diabetes Mellitus

Pregnancy

Menopause

Hypopituitarism, primary hypothyroidism, primary hypogonadism, or treatment with anabolic agents

Abnormal liver function

Abnormal renal function

Active drug or alcohol abuse

Chronic illness other than HIV

BMI less than 23 or greater than 32

Special Instructions: Currently Not Provided
Keywords:
Retrovirus
PCR
Renal Failure
HIV
Recruitment Keywords:
None
Conditions:
AIDS Associated Nephropathy
Focal Glomerulosclerosis
HIV Infections
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Associated focal and segmental glomerulosclerosis in the acquired immunodeficiency syndrome

The nephropathology in human immunodeficiency virus infection

Histopathological changes in simian immunodeficiency virus infection

Active Accrual, Protocols Recruiting New Patients

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