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The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes

HIV Infections Clinical Trial

Official title:
An Open-Label Study of the Safety and Efficacy of Intravitreal ISIS 2922 in Acquired Immune Deficiency Syndrome (AIDS) Patients With Cytomegalovirus Retinitis (NOTE: Restricted to Patients Who Rollover From Another Controlled ISIS 2922 Trial)

Clinical Trial Summary

To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922 therapy on another controlled clinical trial.

PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.

Clinical Trial Description

Patients receive intravitreal injections of ISIS 2922 at doses of either 150 or 300 mcg, depending on CMV retinitis location and extent of retinal involvement. There is a 3-week Induction period followed by at least 18 weeks of Maintenance. Induction is given on days 1, 8, and 15, and Maintenance doses are given every 14 days, beginning on day 29. ;

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002356
Study type Interventional
Source NIH AIDS Clinical Trials Information Service
Contact
Status Completed
Phase Phase 2
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