http://www.nlm.nih.gov/databases/alerts/foscarnet.html
Findings of the Foscarnet-Ganciclovir Cytomegalovirus_retinitis Trial 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_randomized a, 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_explained fully 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 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 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_explained fully by differential anti-retroviral use. However, the trial was_designed not 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 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. U_s. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894 National_institutes_of_health, Department_of_health & Human Services Copyright, Privacy, Accessibility Last updated: 25 March 1997