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