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

NCT ID: NCT00000819

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1996-09-30

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.

Conditions

HIV Infections; AIDS-Associated Nephropathy

Keywords

AIDS-Related Complex; Prednisone; AIDS-Associated Nephropathy

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Prednisone

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Upjohn

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kalayjian R

Role: STUDY_CHAIR

Smith MC

Role: STUDY_CHAIR

Lederman M

Role: STUDY_CHAIR

Locations

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

Countries

United States

References

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

Reference Type: BACKGROUND

Other Identifiers

11247

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 271

Identifier Type: -

Identifier Source: org_study_id