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Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)

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

Purpose

To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.

Background

CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. The first two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy (induction) to control the infection followed by long-term lower dose therapy to prevent relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for CMV retinitis.

Description

The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity.

Patient Eligibility

Males and females eligible for the FGCRT must have been 13 years or older and have had AIDS (CDC definition) or laboratory confirmation of HIV infection and CMV retinitis. They could not have received previous treatment with an anti-CMV drug for their CMV retinitis. Furthermore, they must have had an absolute neutrophil count (ANC) greater than or equal to 1,000 cells/mL and a serum creatinine less than or equal to 2.0 mg/dL in order to tolerate either drug.

Patient Recruitment Status

Completed. Recruitment began in March 1990 and was completed in October 1991.

Current Status of Study

Completed.

Results

The FGCRT demonstrated that foscarnet and ganciclovir were equivalent for controlling CMV retinitis in patients with AIDS. Time to progression, loss of visual acuity, and loss of visual field were similar between the two groups. However, there was a 79 percent excess mortality in the ganciclovir-assigned group, presumably due to an anti-HIV effect of foscarnet. Ganciclovir therapy was associated with a greater rate of neutropenia, whereas foscarnet therapy was associated with greater rates of elevated serum creatinine and abnormalities of serum potassium, calcium, and magnesium. However, side effects were generally manageable and reversible with discontinuation of the appropriate drug.

Publications

Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group: Cytomegalovirus (CMV) culture results, drug resistance and clinical outcome in AIDS patients with CMV treated with either foscarnet or ganciclovir. J Infect Dis July, 1997.

Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group: Clinical features of CMV retinitis at diagnosis. Am J Ophthalmol August, 1997.

Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group: Rhegmatogenous retinal detachments in patients with cytomegalovirus retinitis: Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. Am J Ophthalmol August, 1997.

Studies of Ocular Complications of AIDS in collaboration with the AIDS Clinical Trials Group: Assessment of cytomegalovirus retinitis: Clinical evaluation versus centralized grading of fundus photographs. Arch Ophthalmol 114: 791-805, 1996.

Studies of Ocular Complications of AIDS in collaboration with the AIDS Clinical Trials Group: Clinical vs. photographic assessment of treatment of cytomegalovirus retinitis. Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial Report 8. Arch Ophthalmol 114: 848-855, 1996.

Studies of Ocular Complications of AIDS in collaboration with the AIDS Clinical Trials Group, Coleson LC, Holbrook J, Jabs D: Measuring visual function and quality of life in patients with cytomegalovirus retinitis. Arch Ophthalmol 114: 841-847, 1996.

Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group: Antiviral effects of foscarnet and ganciclovir therapy on human immunodeficiency virus p24 antigen in patients w/ AIDS & cytomegalovirus retinitis. J Infect Dis 172: 613-621, 1995.

Studies of Ocular Complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group: Morbidity and toxic effects associated with ganciclovir or foscarnet therapy in a randomized cytomegalovirus retinitis trial. Arch Intern Med 155: 65-74, 1995.

Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group: Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual Outcomes. Ophthalmology 101: 1250-1261, 1994.

Studies of Ocular Complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group: Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. N Engl J Med 326: 213-220, 1992.

Studies of the Ocular Complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group: Studies of Ocular Complications of AIDS Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial: 1. Rationale, design, and methods. Controlled Clin Trials 13: 22-39, 1992.

Resource Centers

SST Website
Douglas A. Jabs, M.D.
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
http://www.wilmer.jhu.edu/refersst.htm

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

Last Updated: 10/21/99



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