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Home > "C" Clinical Trials Conditions > Cause of Focal Segmental Glomerulosclerosis  Cause of Focal Segmental Glomerulosclerosis
Cause of Focal Segmental Glomerulosclerosis
For Condition: AIDS Associated Nephropathy,Focal Glomerulosclerosis,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details: 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 hyperfiltration. 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 9999
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 940127; 94-DK-0127
Study Start Date: April 7, 1994
Record last reviewed: March 31, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001392
Other Aids Associated Nephropathy Studies:
1. Genetic Markers for Focal Segmental Glomerulosclerosis
2. Cause of Focal Segmental Glomerulosclerosis
Related Studies:
Other AIDS Associated Nephropathy Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Cause of Focal Segmental Glomerulosclerosis
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