A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)

Completed · Phase 2

Conditions studied: HIV Infections, AIDS-Associated Nephropathy

In brief

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.

Key facts

Study ID

NCT00000819

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

54

Expected to finish

1996-09-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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