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

NCT00000697 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-04

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Retinitis
  • HIV Infections

Interventions

DRUG

Foscarnet sodium

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • MA Jacobson

  • CS Crumpacker

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000697 on ClinicalTrials.gov