A randomized, controlled trial of foscarnet in the treatment of cytomegalovirus retinitis in patients with AIDS

Alan G. Palestine, Michael A. Polis, Marc D. De Smet, Barbara F. Baird, Judith Falloon, Joseph A. Kovacs, Richard T. Davey, John J. Zurlo, Kathryn M. Zunich, Matthew Davis, Larry Hubbard, Rosemary Brothers, Frederick L. Ferris, Emily Chew, Janet L Davis, Benjamin I. Rubin, Susan D. Mellow, Julia A. Metcalf, Jody Manischewitz, James R. MinorRobert B. Nussenblatt, Henry Masur, H. Clifford Lane

Research output: Contribution to journalArticle

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Abstract

Objective: To evaluate foscarnet sodium in treating cytomegalovirus retinitis in patients with AIDS. Patients: Twenty-four previously untreated persons with AIDS and cytomegalovirus retinitis who were at low risk for loss of their visual acuity. Intervention: Patients were randomly assigned to receive either no therapy (delayed treatment, control group) or immediate treatment with intravenous foscarnet at a dose of 60 mg/kg body weight three times a day for 3 weeks (induction regimen) followed by a maintenance regimen of 90 mg/kg once a day. Measurements: Patients were examined weekly until they reached the primary clinical end point, defined as progression of their retinitis border by 750 μm or the development of a new retinal lesion due to cytomegalovirus. Progression was evaluated using retinal photographs by masked readers. Secondary evaluations included changes in visual acuity, cytomegalovirus shedding in the blood and urine, serum levels of human immunodeficiency virus type 1 (HIV-1) p24 antigen, and total CD4 T lymphocyte counts. Results: The mean time to progression of retinitis was 3.2 weeks in the control group (n = 11) compared with 13.3 weeks in the treatment group (n = 13) (P < 0.001). Nine of 13 patients in the treatment group had positive blood cultures for cytomegalovirus at entry and all nine cleared their blood of cytomegalovirus by the end of the induction period (P = 0.004) compared with one of six patients in the control group. No reductions in p24 levels were seen in the control patients compared with a reduction of more than 50% in p24 levels for all four patients on treatment for whom follow-up levels were available. The main adverse effects of foscarnet treatment were seizures (2 of 13 patients), hypomagnesemia (9 of 13), hypocalcemia (11 of 13), and elevations in serum creatinine above 176.8 μmol/L (2.0 mg/dL) (3 of 13). The control patients received an average of 0.2 units of blood per week compared with an average of 0.6 units of blood per week for the patients on treatment. Conclusions: The administration of foscarnet decreases the rate of progression of cytomegalovirus retinitis in persons with AIDS, its judicious use is likely to prevent loss of vision in these patients. In this study, however, there was little change in visual acuity in patients in either the immediate or delayed treatment group because only patients with non-sight-threatening disease were selected.

Original languageEnglish
Pages (from-to)665-673
Number of pages9
JournalAnnals of Internal Medicine
Volume115
Issue number9
StatePublished - Nov 1 1991
Externally publishedYes

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Cytomegalovirus Retinitis
Foscarnet
Acquired Immunodeficiency Syndrome
Randomized Controlled Trials
Cytomegalovirus
Therapeutics
Visual Acuity
Retinitis
Control Groups
Hypocalcemia
CD4 Lymphocyte Count
Serum

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Palestine, A. G., Polis, M. A., De Smet, M. D., Baird, B. F., Falloon, J., Kovacs, J. A., ... Lane, H. C. (1991). A randomized, controlled trial of foscarnet in the treatment of cytomegalovirus retinitis in patients with AIDS. Annals of Internal Medicine, 115(9), 665-673.

A randomized, controlled trial of foscarnet in the treatment of cytomegalovirus retinitis in patients with AIDS. / Palestine, Alan G.; Polis, Michael A.; De Smet, Marc D.; Baird, Barbara F.; Falloon, Judith; Kovacs, Joseph A.; Davey, Richard T.; Zurlo, John J.; Zunich, Kathryn M.; Davis, Matthew; Hubbard, Larry; Brothers, Rosemary; Ferris, Frederick L.; Chew, Emily; Davis, Janet L; Rubin, Benjamin I.; Mellow, Susan D.; Metcalf, Julia A.; Manischewitz, Jody; Minor, James R.; Nussenblatt, Robert B.; Masur, Henry; Lane, H. Clifford.

In: Annals of Internal Medicine, Vol. 115, No. 9, 01.11.1991, p. 665-673.

Research output: Contribution to journalArticle

Palestine, AG, Polis, MA, De Smet, MD, Baird, BF, Falloon, J, Kovacs, JA, Davey, RT, Zurlo, JJ, Zunich, KM, Davis, M, Hubbard, L, Brothers, R, Ferris, FL, Chew, E, Davis, JL, Rubin, BI, Mellow, SD, Metcalf, JA, Manischewitz, J, Minor, JR, Nussenblatt, RB, Masur, H & Lane, HC 1991, 'A randomized, controlled trial of foscarnet in the treatment of cytomegalovirus retinitis in patients with AIDS', Annals of Internal Medicine, vol. 115, no. 9, pp. 665-673.
Palestine AG, Polis MA, De Smet MD, Baird BF, Falloon J, Kovacs JA et al. A randomized, controlled trial of foscarnet in the treatment of cytomegalovirus retinitis in patients with AIDS. Annals of Internal Medicine. 1991 Nov 1;115(9):665-673.
Palestine, Alan G. ; Polis, Michael A. ; De Smet, Marc D. ; Baird, Barbara F. ; Falloon, Judith ; Kovacs, Joseph A. ; Davey, Richard T. ; Zurlo, John J. ; Zunich, Kathryn M. ; Davis, Matthew ; Hubbard, Larry ; Brothers, Rosemary ; Ferris, Frederick L. ; Chew, Emily ; Davis, Janet L ; Rubin, Benjamin I. ; Mellow, Susan D. ; Metcalf, Julia A. ; Manischewitz, Jody ; Minor, James R. ; Nussenblatt, Robert B. ; Masur, Henry ; Lane, H. Clifford. / A randomized, controlled trial of foscarnet in the treatment of cytomegalovirus retinitis in patients with AIDS. In: Annals of Internal Medicine. 1991 ; Vol. 115, No. 9. pp. 665-673.
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abstract = "Objective: To evaluate foscarnet sodium in treating cytomegalovirus retinitis in patients with AIDS. Patients: Twenty-four previously untreated persons with AIDS and cytomegalovirus retinitis who were at low risk for loss of their visual acuity. Intervention: Patients were randomly assigned to receive either no therapy (delayed treatment, control group) or immediate treatment with intravenous foscarnet at a dose of 60 mg/kg body weight three times a day for 3 weeks (induction regimen) followed by a maintenance regimen of 90 mg/kg once a day. Measurements: Patients were examined weekly until they reached the primary clinical end point, defined as progression of their retinitis border by 750 μm or the development of a new retinal lesion due to cytomegalovirus. Progression was evaluated using retinal photographs by masked readers. Secondary evaluations included changes in visual acuity, cytomegalovirus shedding in the blood and urine, serum levels of human immunodeficiency virus type 1 (HIV-1) p24 antigen, and total CD4 T lymphocyte counts. Results: The mean time to progression of retinitis was 3.2 weeks in the control group (n = 11) compared with 13.3 weeks in the treatment group (n = 13) (P < 0.001). Nine of 13 patients in the treatment group had positive blood cultures for cytomegalovirus at entry and all nine cleared their blood of cytomegalovirus by the end of the induction period (P = 0.004) compared with one of six patients in the control group. No reductions in p24 levels were seen in the control patients compared with a reduction of more than 50{\%} in p24 levels for all four patients on treatment for whom follow-up levels were available. The main adverse effects of foscarnet treatment were seizures (2 of 13 patients), hypomagnesemia (9 of 13), hypocalcemia (11 of 13), and elevations in serum creatinine above 176.8 μmol/L (2.0 mg/dL) (3 of 13). The control patients received an average of 0.2 units of blood per week compared with an average of 0.6 units of blood per week for the patients on treatment. Conclusions: The administration of foscarnet decreases the rate of progression of cytomegalovirus retinitis in persons with AIDS, its judicious use is likely to prevent loss of vision in these patients. In this study, however, there was little change in visual acuity in patients in either the immediate or delayed treatment group because only patients with non-sight-threatening disease were selected.",
author = "Palestine, {Alan G.} and Polis, {Michael A.} and {De Smet}, {Marc D.} and Baird, {Barbara F.} and Judith Falloon and Kovacs, {Joseph A.} and Davey, {Richard T.} and Zurlo, {John J.} and Zunich, {Kathryn M.} and Matthew Davis and Larry Hubbard and Rosemary Brothers and Ferris, {Frederick L.} and Emily Chew and Davis, {Janet L} and Rubin, {Benjamin I.} and Mellow, {Susan D.} and Metcalf, {Julia A.} and Jody Manischewitz and Minor, {James R.} and Nussenblatt, {Robert B.} and Henry Masur and Lane, {H. Clifford}",
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T1 - A randomized, controlled trial of foscarnet in the treatment of cytomegalovirus retinitis in patients with AIDS

AU - Palestine, Alan G.

AU - Polis, Michael A.

AU - De Smet, Marc D.

AU - Baird, Barbara F.

AU - Falloon, Judith

AU - Kovacs, Joseph A.

AU - Davey, Richard T.

AU - Zurlo, John J.

AU - Zunich, Kathryn M.

AU - Davis, Matthew

AU - Hubbard, Larry

AU - Brothers, Rosemary

AU - Ferris, Frederick L.

AU - Chew, Emily

AU - Davis, Janet L

AU - Rubin, Benjamin I.

AU - Mellow, Susan D.

AU - Metcalf, Julia A.

AU - Manischewitz, Jody

AU - Minor, James R.

AU - Nussenblatt, Robert B.

AU - Masur, Henry

AU - Lane, H. Clifford

PY - 1991/11/1

Y1 - 1991/11/1

N2 - Objective: To evaluate foscarnet sodium in treating cytomegalovirus retinitis in patients with AIDS. Patients: Twenty-four previously untreated persons with AIDS and cytomegalovirus retinitis who were at low risk for loss of their visual acuity. Intervention: Patients were randomly assigned to receive either no therapy (delayed treatment, control group) or immediate treatment with intravenous foscarnet at a dose of 60 mg/kg body weight three times a day for 3 weeks (induction regimen) followed by a maintenance regimen of 90 mg/kg once a day. Measurements: Patients were examined weekly until they reached the primary clinical end point, defined as progression of their retinitis border by 750 μm or the development of a new retinal lesion due to cytomegalovirus. Progression was evaluated using retinal photographs by masked readers. Secondary evaluations included changes in visual acuity, cytomegalovirus shedding in the blood and urine, serum levels of human immunodeficiency virus type 1 (HIV-1) p24 antigen, and total CD4 T lymphocyte counts. Results: The mean time to progression of retinitis was 3.2 weeks in the control group (n = 11) compared with 13.3 weeks in the treatment group (n = 13) (P < 0.001). Nine of 13 patients in the treatment group had positive blood cultures for cytomegalovirus at entry and all nine cleared their blood of cytomegalovirus by the end of the induction period (P = 0.004) compared with one of six patients in the control group. No reductions in p24 levels were seen in the control patients compared with a reduction of more than 50% in p24 levels for all four patients on treatment for whom follow-up levels were available. The main adverse effects of foscarnet treatment were seizures (2 of 13 patients), hypomagnesemia (9 of 13), hypocalcemia (11 of 13), and elevations in serum creatinine above 176.8 μmol/L (2.0 mg/dL) (3 of 13). The control patients received an average of 0.2 units of blood per week compared with an average of 0.6 units of blood per week for the patients on treatment. Conclusions: The administration of foscarnet decreases the rate of progression of cytomegalovirus retinitis in persons with AIDS, its judicious use is likely to prevent loss of vision in these patients. In this study, however, there was little change in visual acuity in patients in either the immediate or delayed treatment group because only patients with non-sight-threatening disease were selected.

AB - Objective: To evaluate foscarnet sodium in treating cytomegalovirus retinitis in patients with AIDS. Patients: Twenty-four previously untreated persons with AIDS and cytomegalovirus retinitis who were at low risk for loss of their visual acuity. Intervention: Patients were randomly assigned to receive either no therapy (delayed treatment, control group) or immediate treatment with intravenous foscarnet at a dose of 60 mg/kg body weight three times a day for 3 weeks (induction regimen) followed by a maintenance regimen of 90 mg/kg once a day. Measurements: Patients were examined weekly until they reached the primary clinical end point, defined as progression of their retinitis border by 750 μm or the development of a new retinal lesion due to cytomegalovirus. Progression was evaluated using retinal photographs by masked readers. Secondary evaluations included changes in visual acuity, cytomegalovirus shedding in the blood and urine, serum levels of human immunodeficiency virus type 1 (HIV-1) p24 antigen, and total CD4 T lymphocyte counts. Results: The mean time to progression of retinitis was 3.2 weeks in the control group (n = 11) compared with 13.3 weeks in the treatment group (n = 13) (P < 0.001). Nine of 13 patients in the treatment group had positive blood cultures for cytomegalovirus at entry and all nine cleared their blood of cytomegalovirus by the end of the induction period (P = 0.004) compared with one of six patients in the control group. No reductions in p24 levels were seen in the control patients compared with a reduction of more than 50% in p24 levels for all four patients on treatment for whom follow-up levels were available. The main adverse effects of foscarnet treatment were seizures (2 of 13 patients), hypomagnesemia (9 of 13), hypocalcemia (11 of 13), and elevations in serum creatinine above 176.8 μmol/L (2.0 mg/dL) (3 of 13). The control patients received an average of 0.2 units of blood per week compared with an average of 0.6 units of blood per week for the patients on treatment. Conclusions: The administration of foscarnet decreases the rate of progression of cytomegalovirus retinitis in persons with AIDS, its judicious use is likely to prevent loss of vision in these patients. In this study, however, there was little change in visual acuity in patients in either the immediate or delayed treatment group because only patients with non-sight-threatening disease were selected.

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