The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
Ionis Pharmaceuticals, Inc.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: December 1998
History of Changes
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.
Drug : Fomivirsen sodium
Masking: None (Open Label)
Primary Purpose: Treatment
|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)|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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.Eligibility
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients must have:
- CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.
- Intolerance or resistance to other therapies.
- Eligibility to participate in a controlled clinical trial of ISIS 2922.
- External ocular infection in eye to be treated.
- Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated.
- Ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated.
- Retinal detachment in eye to be treated.
- Known or suspected allergy to phosphorothioate oligonucleotides.
- Silicone oil in eye to be treated.
- Clinical evidence of retinal pigment epithelial stippling.
- Pseudoretinitis pigmentosa.
- Mellaril, Stelazine, Thorazine, and Clofazimine.
- Ethambutol / fluconazole combination.
- Other investigational drugs for CMV retinitis.
- History of surgery to correct retinal detachment in eye to be treated.
- History of ganciclovir implant for treatment of CMV retinitis.
- History of intolerance to ISIS 2922.
- History of syphilis.
- Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922.
Patients with the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002356
Locations Show More
|United States, California|
|UCI College of Medicine|
|Irvine, California, United States, 92715|
|Retina - Vitreous Associates Med Group|
|Los Angeles, California, United States, 90017|
|Community Eye Med Group|
|Pasadena, California, United States, 911052536|
|San Diego Naval Hosp|
|San Diego, California, United States, 92134|
|Univ of California San Francisco / SF Gen Hosp|
|San Francisco, California, United States, 94110|
|Santa Clara Valley Med Ctr|
|San Jose, California, United States, 95128|
|United States, Colorado|
|Univ of Colorado Health Sciences Ctr|
|Denver, Colorado, United States, 80262|
|United States, District of Columbia|
|Dr Alan Palestine|
|Washington, District of Columbia, United States, 20036|
|United States, Florida|
|Dr Julio Perez|
|Fort Lauderdale, Florida, United States, 33060|
|Bascon Palmer Eye Institute|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|Emory Univ School of Medicine / Emory Eye Ctr|
|Atlanta, Georgia, United States, 30322|
|Atlanta, Georgia, United States, 30327|
|United States, Illinois|
|Univ of Illinois|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Indiana Univ Med Ctr|
|Indianapolis, Indiana, United States, 46202|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70112|
|United States, New York|
|Vitreo - Retinal Consultants|
|New York, New York, United States, 10028|
|United States, North Carolina|
|Charlotte Eye Ear Nose & Throat Association|
|Charlotte, North Carolina, United States, 28204|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Hahnemann Univ Hosp|
|Philadelphia, Pennsylvania, United States, 19102|
|Philadelphia, Pennsylvania, United States, 191461192|
|United States, Texas|
|Univ of Texas Southwestern Med Ctr of Dallas|
|Dallas, Texas, United States, 752359057|
|Houston, Texas, United States, 77004|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Virginia Eye Consultants|
|Norfolk, Virginia, United States, 23507|
|United States, Washington|
|Seattle, Washington, United States, 98104|
Sponsors and CollaboratorsIonis Pharmaceuticals, Inc.
|Responsible Party:||Ionis Pharmaceuticals, Inc.|
|ClinicalTrials.gov Identifier:||NCT00002356 History of Changes|
|Other Study ID Numbers:||251C|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.