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

NCT00000819 | Completed Phase 2

• 2 other identifiers: ACTG 27111247
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 8

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.

Conditions

HIV Infections; AIDS-Associated Nephropathy

Keywords

AIDS-Related Complex; Prednisone; AIDS-Associated Nephropathy

Interventions

Prednisone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Upjohn: collaborator

Study Sites (8)

UCLA CARE Center CRS

Los Angeles, California, 90095, United States

Location

Ucsf Aids Crs

San Francisco, California, United States

Location

Harbor-UCLA Med. Ctr. CRS

Torrance, California, 90502, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10003, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

• Kalayjian R, Phinney M, Austen J, Gripshover B, Carey J, Rahman M, Weigel K, Smith MC. Prednisone improves renal function in HIV-associated nephropathy (HIVAN). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:154

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; AIDS-Associated Nephropathy; AIDS-Related Complex

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kalayjian R

  STUDY CHAIR

• Smith MC

  STUDY CHAIR

• Lederman M

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: September 1, 1996
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (8)