NCT00000819

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections
• AIDS-Associated Nephropathy

Interventions

Type	Name	Description
DRUG	Prednisone

Timeline

• Completion: 1996-09-01
• First posted: 2001-08-31
• Last updated: 2021-10-29

Locations

8 sites across 1 country: United States