A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Cannot Use Ganciclovir

HIV Infections Clinical Trial

Official title: A Phase II Randomized Controlled Trial of Immediate Versus Delayed Foscarnet Therapy in AIDS Patients With Non-Immediately Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due to Myelosuppression

Status Withdrawn

Clinical Trial Summary

To study the safety and effectiveness of foscarnet in the treatment of AIDS patients who have active infection with cytomegalovirus (CMV) that is causing inflammation of the retina (retinitis). In addition, these patients cannot be treated with ganciclovir (DHPG) because of its toxic effect on the body's blood-forming cells or because white blood cell or platelet counts were too low.

CMV is a common virus, which can cause blindness and death in AIDS patients. Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection. Although treatment with ganciclovir (DHPG) is also effective, a significant toxicity leading to dose-limiting neutropenia (low white blood cell count) in one third of treated patients has been associated with the drug. Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients, the present study will evaluate the safety and efficacy of intravenous (IV) foscarnet in AIDS patients with CMV retinitis.

Clinical Trial Description

CMV is a common virus, which can cause blindness and death in AIDS patients. Previous studies demonstrate that foscarnet has been effective in both AIDS and non-AIDS patients with CMV infection. Although treatment with ganciclovir (DHPG) is also effective, a significant toxicity leading to dose-limiting neutropenia (low white blood cell count) in one third of treated patients has been associated with the drug. Based on the serious nature of CMV retinitis and the lack of alternative drug therapies for DHPG-sensitive patients, the present study will evaluate the safety and efficacy of intravenous (IV) foscarnet in AIDS patients with CMV retinitis.

Following routine evaluation studies, patients are randomized to receive foscarnet right away or to delay treatment, as their retinitis has been determined not to be immediately sight-threatening. Patients are hospitalized for the first 3 days and may remain hospitalized for as many as 14 days. Foscarnet is given by vein (IV) in what is called induction therapy, and if the patient's retinitis stabilizes after 2 weeks of treatment, treatment with foscarnet is continued in maintenance therapy for another 8 weeks. During maintenance therapy, patients receive salt solution IV to help prevent any toxic side effect of foscarnet on the kidneys. Patients have regular checkups to monitor their retinitis as well as their general health. Patients taking zidovudine (AZT) prior to entering the study may continue their treatment if they are selected for the delayed treatment group; if they are selected for the immediate treatment group, they begin or resume AZT therapy when they enter the 2nd week of maintenance therapy. Patients are followed as outpatients for at least 10 weeks, with clinic check-ups and lab tests once every week; eye exams are done once a week for the first 2 weeks and then every other week. If clinically indicated, a continued maintenance regimen may be administered after the 10th week; the total duration of therapy plus maintenance is not to exceed 24 weeks. Note: Patients scheduled for the delayed foscarnet treatment are immediately given foscarnet at the first sign that their retinitis is getting worse. ;

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Infections
• Retinitis

• NCT number: NCT00000697
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Withdrawn
• Phase: Phase 2