Completed
Intravitreal ISIS 2922 for AIDS Patients With Cytomegalovirus Retinitis
What is being tested
Fomivirsen sodium
Drug
Who is being recruted
Blood-Borne Infections+22
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorIonis Pharmaceuticals, Inc.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorIonis Pharmaceuticals, Inc.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesCytomegalovirus InfectionsDNA Virus InfectionsEye DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetinal DiseasesRetinitisRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV InfectionsCytomegalovirus Retinitis
Criteria
4 inclusion criteria required to participate
AIDS
CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled
Intolerance or resistance to other therapies
Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922
18 exclusion criteria prevent from participating
Clinical evidence of retinal pigment epithelial stippling
Eligibility to participate in a controlled clinical trial of ISIS 2922
External ocular infection in eye to be treated
History of ganciclovir implant for treatment of CMV retinitis
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 25 locations
Retina - Vitreous Associates Med Group
Los Angeles, United StatesCommunity Eye Med Group
Pasadena, United StatesSan Diego Naval Hosp
San Diego, United StatesCompleted25 Study Centers