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.

Condition
AIDS Associated Nephropathy Focal Glomerulosclerosis HIV Infections

Further Study Details: 

Expected Total Enrollment:  9999

Focal segmental glomerulosclerosis (FSGS) represents a clinicopathologic syndrome, including nephrotic syndrome and a typical renal histologic appearance. FSGS occurs in an idiopathic form and in association with HIV-1 infection, as well as in association with conditions that lead to glomerular hyperfiltation. HIV-associated FSGS affects African-Americans to a disproportionate degree, suggesting that host genetic factors contribute to this complication. Nevertheless, only approximately 10% of African-Americans develop HIV-associated FSGS and it is possible that particular HIV-1 strains are renotropic (localize to kidney) or nephrotoxic (injure kidney). HIV-associated FSGS has particular histologic features that serve to distinguish it from other forms of FSGS; these include glomerular collapse and hypertrophy of glomerular epithelial cells. Recently a new syndrome has been recognized, in which patients have this collapsing variant of FSGS in the absence of serologically-defined HIV-1 infection. We propose two hypotheses: 1) that the pathogenic role of HIV-1 in causing FSGS may be due to variation in certain viral genomic regions, particularly envelope and the accessory genes, 2) that other viruses may contribute to the pathogenesis of idiopathic FSGS. Laboratory analysis includes 1) sequencing of HIV-1 genome from HIV-1 infected patients with and without kidney disease, and measurement of plasma and urine levels of HIV-1 accessory proteins and 2) amplifying by PCR particular viruses from peripheral blood cells and urine cells; these viruses will include parvovirus B19 and polyoma viruses.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Maryland
      National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  940127; 94-DK-0127
Record last reviewed:  March 31, 2004
Last Updated:  April 6, 2005
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001392
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08