Phase II dose-ranging trial of foscarnet salvage therapy for cytomegalovirus retinitis in AIDS patients intolerant of or resistant to ganciclovir (ACTG Protocol 093)
| Autor: | Mark A. Jacobson, Michael Wulfsohn, Judith E. Feinberg, Roger Davis, Maureen Power, Susan Owens, Dennis Causey, Margo E. Heath-Chiozzi, Robert L. Murphy, Tony W. Cheung, Douglas T. Dieterich, Stephen A. Spector, George F. McKinley, David M. Parenti, Clyde Crumpacker |
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| Rok vydání: | 1994 |
| Předmět: |
Ganciclovir
Foscarnet Human cytomegalovirus medicine.medical_specialty Maintenance dose business.industry Immunology virus diseases Salvage therapy Retinitis biochemical phenomena metabolism and nutrition medicine.disease Gastroenterology Surgery Infectious Diseases Internal medicine medicine Immunology and Allergy Cytomegalovirus retinitis Adverse effect business medicine.drug |
| Zdroj: | AIDS. 8:451-460 |
| ISSN: | 0269-9370 |
| Popis: | OBJECTIVE To document response to foscarnet salvage therapy in patients with cytomegalovirus (CMV) retinitis who are intolerant of or resistant to ganciclovir. METHODS Patients with AIDS and CMV retinitis who had documented hematologic intolerance or resistance to ganciclovir therapy received an induction course of foscarnet, 60 mg/kg every 8 h for 14 days, and subsequent chronic maintenance foscarnet therapy at a daily dose of 60, 90 or 120 mg/kg/day. The first 87 patients were randomly assigned to receive maintenance foscarnet at a dose of 60 or 90 mg/kg/day; all subsequent patients were assigned a maintenance dose of 120 mg/kg/day. RESULTS A total of 156 evaluable patients were enrolled. Median time to retinitis progression and survival did not differ significantly among groups assigned to different maintenance foscarnet doses. Among patients with retinitis progression documented ophthalmologically occurring at < or = 2 week intervals, despite optimal doses of ganciclovir, time to progression on foscarnet therapy was a median 8 weeks at all doses studied. By dose assignment, there were no significant differences in serious drug-associated toxicity, although trends toward increased renal and hypocalcemic adverse events were observed at higher maintenance doses. CONCLUSION In patients intolerant of ganciclovir, salvage foscarnet therapy resulted in a longer time to retinitis progression than reported previously in historic controls who terminated ganciclovir therapy. In patients who exhibited clinical resistance to ganciclovir, foscarnet appeared to have efficacy in controlling retinitis. No significant differences in either efficacy or toxicity were observed in the range of foscarnet maintenance doses studied. |
| Databáze: | OpenAIRE |
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