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

Phase 2

Completed

• Conditions: HIV Infections; AIDS-Associated Nephropathy

• Registration Number: NCT00000819
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Study Timeline

• Study Completion: 1996-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (8)

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