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Findings of the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial

National Eye Institute (NEI)
October 29, 1991

Abstract:

Important information on survival in persons with AIDS who have CMV retinitis is being provided as a Clinical Alert (summary follows), while a publication is being prepared for submission to a peer-reviewed medical journal.

The Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial, supported by the National Eye Institute, is a randomized, multicenter clinical trial designed to evaluate the relative efficacy and safety of foscarnet and ganciclovir for the initial treatment of CMV retinitis. The trial's independent Policy and Data Monitoring Board recommended suspending the protocol because the data indicated that patients treated with foscarnet lived on average four months longer than those treated with ganciclovir. The difference in survival could not be explained by variations in disease severity at the time patients entered the study or to other chance factors. Nor could the mortality difference be fully explained by the differential use of zidovudine or other anti-retroviral drugs by patients in the two treatment groups. Foscarnet and ganciclovir appeared to be equally effective in halting the progression of CMV retinitis and preserving vision. While a survival benefit for foscarnet was seen in most patients, in the group of patients who entered the study with a predicted creatinine clearance <1.2 ml/min/kg, a survival benefit was seen for ganciclovir. Creatinine clearance (CrCl) is estimated from serum creatinine as: CrCl=(140-age)/(creatinine x 72) for males; CrCl=((140-age)/creatinine x 72))x0.85 for females.

These findings suggest that foscarnet may be the preferable initial treatment for CMV retinitis, with the exception of patients with decreased renal function. The complete Clinical Alert is available from the AIDS Clinical Trials Information Service, 1-800-TRIALS-A. This 800 number can be reached from Canada as well.

The treatment protocols for this alert have been mailed to all libraries that are members of the National Network of LIbraries of Medicine.

Full Text:

This alert informs you of findings from the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. This randomized, multicenter clinical trial is supported by the National Eye Institute, a component of the National Institutes of Health (NIH). It was conducted in collaboration with the AIDS Clinical Trials Group sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) at NIH.

The trial was designed to evaluate the relative efficacy and safety of foscarnet and ganciclovir for the initial treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. On October 7, the trial's independent Policy and Data Monitoring Board recommended suspending the protocol because the data indicated that patients treated with foscarnet lived on average four months longer than those treated with ganciclovir. The median survival for those treated with foscarnet was approximately 12 months, compared to eight months for those treated with ganciclovir. The difference in survival could not be explained by variations in disease severity at the time patients entered the study or to other chance factors.

Foscarnet and ganciclovir appeared to be equally effective in halting the progression of CMV retinitis and preserving vision. While a survival benefit for foscarnet was seen in most patients, in the group of patients who entered the study with a predicted creatinine clearance <1.2 ml/min/kg, a survival benefit was seen for ganciclovir.

Within the trial, anti-retroviral therapy [zidovudine (AZT), ddI, and ddC] was used according to best medical judgment. The difference in mortality between the foscarnet-treated patients and the ganciclovir-treated patients could not be fully explained by differential anti-retroviral use. However, the trial was not designed to study possible interactions between anti-CMV and anti-HIV treatments. Therefore, such an explanation cannot be ruled out.

These findings suggest that foscarnet may be the preferable initial treatment for CMV retinitis. A possible exception is the subgroup of patients with decreased renal function (predicted creatinine clearance <1.2 ml/min/kg) who appeared to do better on ganciclovir.

The complete findings from this study will be published soon. This announcement is being sent in advance of journal publication to physicians likely to treat patients with AIDS who have CMV retinitis. A press conference was held on October 21 at the National Institutes of Health.

For a copy of the treatment administration protocols used in this trial, you may contact one of the clinical investigators listed below or call 1-800-TRIALS-A.


Clinical Centers


Studies of the Ocular Complications of AIDS (SOCA)


California

Gary Holland, M.D.
Doris Stein Eye Research Institute
UCLA School of Medicine
100 Stein Plaza
Los Angeles, California 90024-7007
Telephone: (213)825-9508
William Freeman, M.D.
Eye Center, M-018
University of California at San Diego
Osler Lane
La Jolla, California 92093
Telephone: (619) 534-3513
James O'Donnell, M.D.
Beckman Vision Center
Department of Ophthalmology
University of California at San Francisco
Box 0730, Room K-301
10 Kirkham Street
San Francisco, California 94143
Telephone: (415) 476-1921

Florida

Janet Davis, M.D.
Bascom Palmer Eye Institute
University of Miami School of Medicine
900 N.W. 17th Street
Miami, Florida 33136
Telephone: (305) 326-6377

Illinois

David Weinberg, M.D.
Department of Ophthalmology
Northwestern University Medical School
645 North Michigan, Suite 520
Chicago, Illinois 60611
Telephone: (312) 944-7494

Louisiana

Bruce Barron, M.D.
Eye Center
Louisiana State University Medical Center
2020 Gravier Street, Suite B
New Orleans, Louisiana 70112
Telephone: (504) 568-6700 ext. 381

Maryland

Douglas A. Jabs, M.D.
Wilmer Ophthalmological Institute
The Johns Hopkins Medical Institutions
550 North Broadway, Suite 700
Baltimore, Maryland 21205
Telephone: (301) 955-2966

Massachusetts

Sarah H. Cheeseman, M.D.
University of Massachusetts Medical Center
Division of Infectious Diseases
55 Lake Avenue, North
Worcester, Massachusetts 01655
(508) 856-3158

New York

Murk-Hein Heinemann, M.D.
Memorial Sloan-Kettering Cancer Center
1275 York Avenue, Suite A325
New York, New York 10021
Telephone: (212) 639-7237
Alan Friedman, M.D.
Department of Ophthalmology
Mount Sinai School of Medicine
Box 1183
One Gustave L. Levy Place
New York, New York 10029-6574
Telephone: (212) 241-6241
Dorothy Friedberg, M.D.
Department of Ophthalmology
New York University Medical Center
310 Lexington Avenue
New York, New York 10016
Telephone: (212) 687-0265

Texas

Richard Lewis, M.D.
Cullen Eye Institute
Baylor College of Medicine
6501 Fannin, NC-200
Houston, Texas 77030
Telephone: (713) 798-6100

NOTE: This Clinical Alert, as issued by the NIH, contained graphic or tabular material which precluded its presentation online.