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Home » Resources » Clinical Studies » Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

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Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

Information About Other SOCA Studies.

Purpose | Background | Description | Patient Eligibility | Recruitment Status | Current Status | Results | Publications | Resource Centers | NEI Representative

Purpose

Background

Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in these patients, making CMV retinitis the most common ocular infection encountered. CMV retinitis is a relatively late-stage manifestation, associated with CD4+ T-cell counts < 100 cells/l and often < 50 cells/l.

All currently available treatments for CMV suppress viral replication but do not eliminate the virus from the body. Discontinuation of therapy is associated with a prompt relapse of the retinitis. Despite the use of chronic suppressive therapy, relapse of the retinitis generally occurs, at least with systemically administered anti-CMV drugs.

The first two treatments approved for CMV retinitis were intravenous ganciclovir and intravenous foscarnet. Both are given by daily intravenous infusions and therefore require central venous catheters. The development of newer treatments has focused not only on efficacious treatments, but also on treatments that do not require central venous catheters. Available treatments now include oral ganciclovir, the ganciclovir intraocular device, and intravenous cidofovir.

In vitro data suggest that combination therapies are synergistic in inhibiting viral replication; these therapies include a foscarnet-ganciclovir combination and a cidofovir-ganciclovir combination. In the SOCA--CMV Retinitis Retreatment Trial, the combination of intravenous ganciclovir and foscarnet was more effective than either drug alone for the treatment of relapsed retinitis. Therefore, the combination of intermittent intravenous cidofovir and daily oral ganciclovir may be an attractive therapy for relapsed disease because it may provide synergy for controlling both ocular and visceral disease while not necessitating either a central venous catheter or an intraocular surgical procedure.

Description

The Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) is a randomized, multicenter clinical trial. Patients will be assigned to receive one of two regimens: (1) ganciclovir intraocular device plus oral ganciclovir or (2) intravenous cidofovir. The intraocular device will be surgically implanted at baseline and again every 6 to 8 months in eyes with CMV retinitis. Oral ganciclovir is taken at a dose of 1 gram three times daily. Cidofovir will be administered intravenously at 5 mg/kg once weekly for 2 consecutive weeks and once every 2 weeks thereafter. If disease progression occurs in patients receiving cidofovir, patients will be given reinduction therapy, and oral ganciclovir at a dose of 1 gram three times per day will be added to the treatment. If patients assigned to cidofovir are unable to tolerate that regimen, an alternative systemic regimen will be recommended.

Study outcome variables include a decrease of three or more lines from baseline in best corrected visual acuity and rate of visual field loss. The study will also assess other variables including mortality, blood CMV and HIV load, quality of life, and medical costs.

Treatment assignment will not be masked to either patients or clinicians; however, reading of fundus photographs to determine both change in retinal involvement and progression will be masked.

Patient Eligibility

Males and females age 13 years and older with diagnoses of AIDS and active CMV retinitis will be eligible. Patients must have a best corrected visual acuity of > 20/100 in at least one eye affected by CMV retinitis with at least one lesion 750 or greater that can be photographed.

Patient Recruitment Status

Completed.

Current Status of Study

Completed.

Results

None.

Publications

None.

Resource Centers

Chairman's Office
Douglas A. Jabs
The Wilmer Ophthalmological Institute
Department of Ophthalmology
The Johns Hopkins University School of Medicine
550 North Broadway, Suite 700
Baltimore, MD 21205
Telephone: (410) 955-1966

Coordinating Center
Curtis L. Meinert, Ph.D.
Department of Epidemiology
School of Hygiene and Public Health
The Johns Hopkins University
615 North Wolfe Street, Room 5010
Baltimore, MD 21205
Telephone: (410) 955-8198

SOCA Website
http://www.jhsph.edu/Research/Centers/CCT/soca

NEI Representative

Natalie Kurinij, Ph.D.
National Eye Institute
National Institutes of Health
Executive Plaza South, Suite 350
6120 Executive Boulevard, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-5983
Fax: (301) 402-0528

Data and Safety Monitoring Committee

Byron William Brown, Jr., Ph.D.
Stanford University
Stanford, CA

Brian P. Conway, M.D.
University of Virginia
Charlottesville, VA

James E. Grizzle, Ph.D.
University of Washington
Seattle, WA

Robert B. Nussenblatt, M.D.
National Eye Institute
National Institutes of Health
Bethesda, MD

John P. Phair, M.D.
Northwestern University Medical School
Chicago, IL

Harmon Smith, Ph.D.
Duke University
Durham, NC

Richard J. Whitley, M.D.
University of Alabama at Birmingham
Birmingham, AL

Ex Officio Members

Beverly Alston, M.D.
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD

Matthew D. Davis, M.D.
University of Wisconsin
Madison, WI

Douglas A. Jabs, M.D.
The Johns Hopkins University
Baltimore, MD

Curtis L. Meinert, Ph.D.
The Johns Hopkins University
Baltimore, MD

Natalie Kurinij, Ph.D.
National Eye Institute
National Institutes of Health
Bethesda, MD

James Tonascia, Ph.D.
The Johns Hopkins University
Baltimore, MD

Last Updated: 10/5/01



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