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.
Last Reviewed: July 31, 2020