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A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) Clinical research trials and A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN). A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) clinical trial. Human subjects often obtain the finest healthcare possible for their A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN) condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)  A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
For Condition: HIV Infections,AIDS-Associated Nephropathy
Status: Completed
Sponsor(s): Upjohn , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: To determine the efficacy and safety of prednisone in patients with HIV-associated nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and creatinine clearance. HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.
Details: HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted. Patients are randomized to receive prednisone or placebo for 11 weeks, followed by 13 weeks of observation.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV infection. - Biopsy-confirmed glomerulosclerosis and/or mesangial proliferation within 90 days prior to study entry. - Mild to severe renal insufficiency that is stable or worsening. - No AIDS-defining opportunistic infections or malignancies. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Poorly controlled hypertension or diabetes mellitus. - Peptic ulcer disease with gastrointestinal bleeding. - Active symptomatic bacterial, protozoal, fungal, or viral infections (other than HIV disease). - Superimposed renal disease that is due to processes other than focal glomerulosclerosis or mesangial proliferation, including but not limited to obstructive uropathy, acute tubular necrosis, and prerenal azotemia. - Emotional problems sufficient to prevent adequate compliance with study therapy. Concurrent Medication: Excluded: - IV amphotericin B. - IV aminoglycosides. - IV foscarnet. - IV pentamidine. - Trimethoprim > 200 mg/day. - Nonsteroidal anti-inflammatory agents. - Angiotensin converting enzyme inhibitors (benzapril, captopril, enalapril, fosinopril, lisinopril, guinapril, and ramipril) except for refractory hypertension. Concurrent Treatment: Excluded: - Iodinated radiocontrast dye. Patients with the following prior conditions are excluded: - Active pulmonary disease on chest radiograph within 60 days prior to study entry. - CMV retinitis on ophthalmologic evaluation within 60 days prior to study entry. - Positive blood culture for mycobacteria 10-60 days prior to study entry. Prior Medication: Excluded: - Prior corticosteroid therapy for HIVAN. - Corticosteroid therapy for any indication within 30 days prior to study entry. - Continuous nonsteroidal anti-inflammatory agents for more than 15 days during the 4 weeks prior to study entry. Prior Treatment: Excluded within 30 days prior to study entry: - Dialysis for acute or chronic renal failure. - Iodinated radiocontrast dye. Required: - Stable antiretroviral therapy with AZT alone or in combination with ddI, ddC, or d4T for at least 4 weeks unless contraindicated. - PCP prophylaxis with TMP/SMX, pentamidine aerosol, dapsone, or atovaquone. - MAC prophylaxis with rifabutin or clarithromycin for patients with CD4 count < 100 cells/mm3. - Mycobacterium tuberculosis prophylaxis with isoniazid or another accepted regimen for patients with a positive or previously positive tuberculin test and for anergic patients who are known household or close contacts of infectious TB patients or who are from groups in which the prevalence of TB is 10 percent or higher. - Investigational drugs unless exempted by protocol chair. - Other medications unless expressly prohibited. Active alcohol or drug abuse.
Total Enrollment: 54
Location and Contact Information:
Overall Study Official:
KalayjianR, Study Chair,
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Additional Information:
Study ID Numbers: ACTG 271;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000819
Other Hiv Infections Studies:
1. A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
2. A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients with HIV-Associated Kidney Disease
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A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
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