Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. Studies of Ocular Complications of AIDS Research Group, in collaboration with the AIDS Clinical Trials Group

Volume 326:213-220		January 23, 1992		Number 4

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Abstract

BACKGROUND AND METHODS. We performed a multicenter, randomized, unblinded clinical trial (the Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial) designed to compare ganciclovir with foscarnet in the treatment of cytomegalovirus retinitis in patients with the acquired immunodeficiency syndrome (AIDS). Of 234 patients, 127 were randomly assigned to ganciclovir and 107 to foscarnet; the study drugs were administered according to a common protocol at the 11 participating clinical centers. Antiretroviral therapy (with zidovudine, didanosine, or dideoxycytidine) was given as dictated by best medical judgment. The patients were followed for the progression of retinitis, visual loss, and death. RESULTS. Excess mortality in the ganciclovir group (as compared with the foscarnet group) led the Policy and Data Monitoring Board to recommend suspension of the treatment protocol 19 months after the trial started. As of that time, 65 of the patients assigned to ganciclovir had died, as compared with 36 of those assigned to foscarnet (51 percent vs. 34 percent, P = 0.007; relative risk, 1.79; 95 percent confidence interval, 1.17 to 2.73). The median survival was 8.5 months in the ganciclovir group and 12.6 months in the foscarnet group. Although the patients assigned to ganciclovir received less antiretroviral therapy on average than those assigned to foscarnet, the excess mortality could not be explained entirely by differences in exposure to antiretroviral drugs. In the forscarnet group, the only subgroup of patients identified as having excess mortality were those whose renal function was compromised at entry. There was no difference between the two treatment groups in the rate of progression of retinitis (relative risk, 0.95; P = 0.751). CONCLUSIONS. These results suggest that for patients with AIDS, and cytomegalovirus retinitis, treatment with foscarnet offers a survival advantage over treatment with ganciclovir, although the patients may not tolerate foscarnet as well as ganciclovir.

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Whitcup, S. M. (2000). Cytomegalovirus Retinitis in the Era of Highly Active Antiretroviral Therapy. JAMA 283: 653-657 [Abstract] [Full Text]
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Eong, K G A., Beatty, S, Charles, S J (1999). HIV medicine: Cytomegalovirus retinitis in patients with acquired immune deficiency syndrome. Postgrad. Med. J. 75: 585-590 [Abstract] [Full Text]
Mitchell, S. M, Membrey, W. L, Youle, M. S, Obi, A., Worrell, S., Gazzard, B. G (1999). Cytomegalovirus retinitis after the initiation of highly active antiretroviral therapy: a 2�year prospective study. Br J Ophthalmol 83: 652-655 [Abstract] [Full Text]
Plummer, D. J., Banker, A., Taskintuna, I., Azen, S. P., Sample, P. A., LaBree, L., Freeman, W. R. (1999). The Utility of Entoptic Perimetry as a Screening Test for Cytomegalovirus Retinitis. Arch Ophthalmol 117: 202-207 [Abstract] [Full Text]
Zeichner, S. L. (1998). Foscarnet. Pediatr. Rev. 19: 399-400 [Full Text]
Tachedjian, G., French, M., Mills, J. (1998). Coresistance to Zidovudine and Foscarnet Is Associated with Multiple Mutations in the Human Immunodeficiency Virus Type 1�Reverse Transcriptase. Antimicrob. Agents Chemother. 42: 3038-3043 [Abstract] [Full Text]
Whitley, R. J., Jacobson, M. A., Friedberg, D. N., Holland, G. N., Jabs, D. A., Dieterich, D. T., Hardy, W. D., Polis, M. A., Deutsch, T. A., Feinberg, J., Spector, S. A., Walmsley, S., Drew, W. L., Powderly, W. G., Griffiths, P. D., Benson, C. A., Kessler, H. A., for the International AIDS Society-USA, (1998). Guidelines for the Treatment of Cytomegalovirus Diseases in Patients With AIDS in the Era of Potent Antiretroviral Therapy: Recommendations of an International Panel. Arch Intern Med 158: 957-969 [Abstract] [Full Text]
Smith, I. L., Taskintuna, I., Rahhal, F. M., Powell, H. C., Ai, E., Mueller, A. J., Spector, S. A., Freeman, W. R. (1998). Clinical Failure of CMV Retinitis With Intravitreal Cidofovir Is Associated With Antiviral Resistance. Arch Ophthalmol 116: 178-185 [Abstract] [Full Text]
The Studies of Ocular Complications of AIDS Resear, (1997). MSL-109 Adjuvant Therapy for Cytomegalovirus Retinitis in Patients With Acquired Immunodeficiency Syndrome: The Monoclonal Antibody Cytomegalovirus Retinitis Trial. Arch Ophthalmol 115: 1528-1536 [Abstract]
Kravcik, S. (1997). Cidofovir for Cytomegalovirus Retinitis. ANN INTERN MED 127: 490-490 [Full Text]
Musch, D. C., Martin, D. F., Gordon, J. F., Davis, M. D., Kuppermann, B. D., The Ganciclovir Implant Study Group, (1997). Treatment of Cytomegalovirus Retinitis with a Sustained-Release Ganciclovir Implant. NEJM 337: 83-90 [Abstract] [Full Text]
Jacobson, M. A. (1997). Treatment of Cytomegalovirus Retinitis in Patients with the Acquired Immunodeficiency Syndrome. NEJM 337: 105-114 [Full Text]
Jabs, D. A. (1997). Cidofovir. Arch Ophthalmol 115: 785-786 [Abstract]
Whitcup, S. M., Fortin, E., Nussenblatt, R. B., Polis, M. A., Muccioli, C., Belfort, R. Jr (1997). Therapeutic Effect of Combination Antiretroviral Therapy on Cytomegalovirus Retinitis. JAMA 277: 1519-1520 [Abstract]
Baumal, C. R., Levin, A. V., Kavalec, C. C., Petric, M., Khan, H., Read, S. E. (1996). Screening for Cytomegalovirus Retinitis in Children. Arch Pediatr Adolesc Med 150: 1186-1192 [Abstract]
Crumpacker, C. S. (1996). Ganciclovir. NEJM 335: 721-729 [Full Text]
The Studies of Ocular Complications of AIDS Resear, (1996). Assessment of Cytomegalovirus Retinitis: Clinical Evaluation vs Centralized Grading of Fundus Photographs. Arch Ophthalmol 114: 791-805 [Abstract]
Hoover, D. R., Peng, Y., Saah, A., Semba, R., Detels, R. R., Rinaldo, C. R. Jr, Phair, J. P. (1996). Occurrence of Cytomegalovirus Retinitis After Human Immunodeficiency Virus Immunosuppression. Arch Ophthalmol 114: 821-827 [Abstract]
Plummer, D. J., Arevalo, J. F., Fram, N., Quiceno, J. I., Sample, P. A., Freeman, W. R. (1996). Effectiveness of Entoptic Perimetry for Locating Peripheral Scotomas Caused by Cytomegalovirus Retinitis. Arch Ophthalmol 114: 828-831 [Abstract]
Wu, A. W., Coleson, L. C., Holbrook, J., Jabs, D. A., Studies of Ocular Complication of AIDS Research Gr, (1996). Measuring Visual Function and Quality of Life in Patients With Cytomegalovirus Retinitis: Development of a Questionnaire. Arch Ophthalmol 114: 841-847 [Abstract]
Studies of Ocular Complications of AIDS Research G, (1996). Clinical vs Photographic Assessment of Treatment of Cytomegalovirus Retinitis: Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial Report 8. Arch Ophthalmol 114: 848-855 [Abstract]
Jabs, D. A. (1996). Acquired Immunodeficiency Syndrome and the Eye--1996. Arch Ophthalmol 114: 863-866 [Abstract]
Spector, S. A., McKinley, G. F., Lalezari, J. P., Samo, T., Andruczk, R., Follansbee, S., Sparti, P. D., Havlir, D. V., Simpson, G., Buhles, W., Wong, R., Stempien, M. J., The Roche Cooperative Oral Ganciclovir Study Group, (1996). Oral Ganciclovir for the Prevention of Cytomegalovirus Disease in Persons with AIDS. NEJM 334: 1491-1497 [Abstract] [Full Text]
Whitcup, S. M. (1996). Ocular Manifestations of AIDS. JAMA 275: 142-144 [Abstract]
Young, L. H. Y. (1996). Therapy for Cytomegalovirus Retinitis: Still No Silver Lining. JAMA 275: 149-150 [Abstract]
The Studies of Ocular Complications of AIDS Resear, (1996). Combination Foscarnet and Ganciclovir Therapy vs Monotherapy for the Treatment of Relapsed Cytomegalovirus Retinitis in Patients With AIDS: The Cytomegalovirus Retreatment Trial. Arch Ophthalmol 114: 23-33 [Abstract]
Davis, J. L., Serfass, M. S., Lai, M.-Y., Trask, D. K., Azen, S. P. (1995). Silicone Oil in Repair of Retinal Detachments Caused by Necrotizing Retinitis in HIV Infection. Arch Ophthalmol 113: 1401-1409 [Abstract]
Drew, W. L., Ives, D., Lalezari, J. P., Crumpacker, C., Follansbee, S. E., Spector, S. A., Benson, C. A., Friedberg, D. N., Hubbard, L., Stempien, M. J., Shadman, A., Buhles, W., The Syntex Cooperative Oral Ganciclovir Study Grou, (1995). Oral Ganciclovir as Maintenance Treatment for Cytomegalovirus Retinitis in Patients with AIDS. NEJM 333: 615-620 [Abstract] [Full Text]
Polis, M. A., Masur, H. (1995). Promising New Treatments for Cytomegalovirus Retinitis. JAMA 273: 1457-1459 [Abstract]
Studies of Ocular Complications of AIDS Research G, , AIDS Clinical Trials Group, , Lewis, R. A., Clogston, P., Fainstein, V., Gross, R., Samo, T., Tuttle, C., Jabs, D. A., Apuzzo, L., Bartlett, J., Coleson, L., Dunn, J. P., Eldred, L., Feinberg, J., Flynn, T., King, R., Leslie, J., Barron, B., Greenspan, D., Le-Count, C., Peyman, G., Franklin, R., Heinemann, M.-H., Polsky, B., Squires, K., Wise-Campbell, S., Friedman, A. H., Cheung, T. W., Justin, N., Teich, S., Sacks, H., Severin, C., Friedberg, D. N., Addessi, A., Dieterich, D., Frost, K., Weinberg, D., Jampol, L., Murphy, R., Naughton, K., Henderly, D., Holland, G. N., Chafey, S., Fall, H., Hardy, W. D., Kimbrell, C., MacArthur, L. J., Freeman, W. R., Meixnert, L., Peterson, T. J., Quiceno, J. I., Rickman, L., Simanello, M. A., Spector, S., O'Donnell, J., Hoffman, J., Irvine, A., Jacobson, M., Larson, J., Seiff, S., Wanner, M., Davis, J., Chuang, E., Espinal, M., Mendez, P., Vandenbroucke, R., Cheeseman, S. H., Gittinger, J., Haubrich, R., Kachadoorian, H., Tolson, K., Jabs, D. A., Kline, J. M., Klemm, A. C., Stevens, M., Webb, R., Brown-Bellamy, J., Markowitz, J. A., Meinert, C. L., Binder, K. L., Brookmeyer, R., Brown, V. E., Collison, B. J., Dodge, J., Donithan, M., Fink, N., Gerczak, C., Holbrook, J. T., Isaacson, M. R., Jones, C. P., Levine, C. R., Min, Y.-I, Meinert, J. L., Owens, R. M., Nowakowski, D. J., Saah, A., Sandford, G. R., Singer, S., Smith, M., Sternberg, A. L., Tonascia, J., Van Natta, M. L., Davis, M. D., Agres-Segal, M., Armstrong, J., Brothers, R., Freitag, G., Hubbard, L., Hurlburt, D., Kastorff, L., Magli, Y., Miner, K., Thomas, S., Vanderhoof-Young, M., Stewart, G., Hughes, R., Welch, L., Mowery, R., Ellenberg, S., Korvick, J., Jabs, D. A., Davis, M. D., Meinert, C. L., Mowery, R., Jabs, D. A., Barron, B., Clark, T., Clogston, P. S., Davis, M. D., Dieterich, D., Espinal, M., Freeman, W., Hardy, W. D., Holbrook, J. T., Holland, G. N., Hubbard, L., Korvick, J., Lewis, R. A., Markowitz, J. A., Meinert, C. L., Mowery, R., Polsky, B., Tonascia, J., Jabs, D. A., Davis, M. D., Ellenberg, S., Feinberg, J., Jacobson, M., Korvick, J., Meinert, C. L., Mowery, R., Sattler, F., Tonascia, J., Jordan, C., Mills, J., Brown, B. W. Jr, Conway, B., Grizzle, J., Nussenblatt, R., Phair, J., Smith, H., Davis, M. D., Ellenberg, S., Jabs, D. A., Meinert, C. L., Mowery, R., Tonascia, J. (1995). Morbidity and Toxic Effects Associated With Ganciclovir or Foscarnet Therapy in a Randomized Cytomegalovirus Retinitis Trial. Arch Intern Med 155: 65-74 [Abstract]
Martin, D. F., Parks, D. J., Mellow, S. D., Ferris, F. L., Walton, R. C., Remaley, N. A., Chew, E. Y., Ashton, P., Davis, M. D., Nussenblatt, R. B. (1994). Treatment of Cytomegalovirus Retinitis With an Intraocular Sustained-Release Ganciclovir Implant: A Randomized Controlled Clinical Trial. Arch Ophthalmol 112: 1531-1539 [Abstract]
Morlet, N., Young, S. H., Coroneo, M. T. (1994). Ganciclovir Intraocular Device and Patient Survival. Arch Ophthalmol 112: 1404-1404 [Abstract]
Parrish, R. II (1994). Who Owns What I Say? Oral Presentations, Scientific Publications, and 'The Times'. Arch Ophthalmol 112: 1157-1158 [Abstract]
D'Amico, D. J. (1994). Diseases of the Retina. NEJM 331: 95-106 [Full Text]
Moore, R. D., Stanton, D., Gopalan, R., Chaisson, R. E. (1994). Racial Differences in the Use of Drug Therapy for HIV Disease in an Urban Community. NEJM 330: 763-768 [Abstract] [Full Text]
Spaide, R. F. (1994). Ganciclovir Intraocular Device and Patient Survival. Arch Ophthalmol 112: 19-20 [Abstract]
Geier, S. A., Sadri, I., Bogner, J. R., Goebel, F. D. (1994). Ganciclovir Intraocular Device and Patient Survival. Arch Ophthalmol 112: 20-20 [Abstract]
Anand, R., Nightingale, S. D., Fish, R. H., Smith, T. J., Ashton, P. (1994). Ganciclovir Intraocular Device and Patient Survival-Reply. Arch Ophthalmol 112: 20-21 [Abstract]
Hoover, D. R., Saah, A. J., Bacellar, H., Phair, J., Detels, R., Anderson, R., Kaslow, R. A., The Multicenter AIDS Cohort Study, (1993). Clinical Manifestations of AIDS in the Era of Pneumocystis Prophylaxis. NEJM 329: 1922-1926 [Abstract] [Full Text]
Kuppermann, B. D., Flores-Aguilar, M., Quiceno, J. I., Rickman, L. S., Freeman, W. R. (1993). Combination Ganciclovir and Foscarnet in the Treatment of Clinically Resistant Cytomegalovirus Retinitis in Patients With Acquired Immunodeficiency Syndrome. Arch Ophthalmol 111: 1359-1366 [Abstract]
Brusch, J. L., Mark, E. J. (1993). Case 34-1993- A 36-Year-Old Man with AIDS and Respiratory Failure. NEJM 329: 645-653 [Full Text]
Hirsch, M. S., D'Aquila, R. T. (1993). Therapy for Human Immunodeficiency Virus Infection. NEJM 328: 1686-1695 [Full Text]
Jewett, J. F., Hecht, F. M. (1993). Preventive Health Care for Adults With HIV Infection. JAMA 269: 1144-1153 [Abstract]
Anand, R., Nightingale, S. D., Fish, R. H., Smith, T. J., Ashton, P. (1993). Control of Cytomegalovirus Retinitis Using Sustained Release of Intraocular Ganciclovir. Arch Ophthalmol 111: 223-227 [Abstract]
Holland, G. N., Shuler, J. D. (1992). Progression Rates of Cytomegalovirus Retinopathy in Ganciclovir-Treated and Untreated Patients. Arch Ophthalmol 110: 1435-1442 [Abstract]
McLeod, G. X., Hammer, S. M. (1992). Zidovudine: Five Years Later. ANN INTERN MED 117: 487-501 [Abstract]
O'Brien, T. P., Goldberg, M. F. (1992). Ophthalmology. JAMA 268: 393-395 [Abstract]
Jabs, D. A. (1992). Treatment of Cytomegalovirus Retinitis--1992. Arch Ophthalmol 110: 185-187 [Abstract]
(1992). FOSCARNET, GANCICLOVIR, AND SURVIVAL IN AIDS PATIENTS WITH RETINITIS. JWatch General 1992: 6-6 [Full Text]

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