A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002187
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1998
  Purpose

The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Fomivirsen sodium

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Oral ganciclovir.
  • Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia.

Patients must have:

  • Documented AIDS.
  • Clinical diagnosis of advanced CMV retinitis in 1 or both eyes.
  • >= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.
  • > 25% retinal involvement with CMV retinitis.
  • Baseline CMV retinitis lesions which have leading edges > 1000 micrograms from the macula or optic disk.

Prior Medication:

Required:

  • >= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.

Allowed:

  • All anti-CMV therapies other than ganciclovir must be discontinued no less than 2 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • External ocular infection in the eye to be treated.
  • Other herpetic infections of the retina, toxoplasma, retinochoroiditis, or other disease of the fundus that would preclude assessment of CMV retinitis in the eye to be treated.
  • Ocular conditions that will obstruct visualization of the posterior ocular structures on the eye to be treated.
  • Retinal detachment in the eye to be treated.
  • Ganciclovir implant in the eye to be treated.
  • Known or suspected allergy to phosphorothioate oligonucleotides or intolerance of ISIS 2922.
  • Silicone oil in the eye to be treated.
  • Pseudoretinitis pigmentosa.
  • Syphilis.

Patients with the following prior conditions are excluded:

  • History of surgery to correct retinal detachment in the eye to be treated.
  • History of syphilis.

    1. Systemic anti-CMV therapies other than oral ganciclovir.

  • Mellaril, Stelazine, chlorpromazine and clofazimine.
  • Combination use of ethambutol and fluconazole.
  • Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated.
  • Ganciclovir implant delivery device in the eye to be treated.
  • Ganciclovir other than oral.
  • Foscarnet.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002187

Locations
United States, California
Retina - Vitreous Associates Med Group
Los Angeles, California, United States, 90017
Community Eye Med Group
Pasadena, California, United States, 911052536
Dr Jacob Lalezari
San Francisco, California, United States, 94115
Univ of California San Francisco / SF Gen Hosp
San Francisco, California, United States, 94110
United States, District of Columbia
Dr Alan Palestine
Washington, District of Columbia, United States, 20006
United States, Florida
Dr Julio Perez
Fort Lauderdale, Florida, United States, 33060
United States, Georgia
Georgia Retina
Atlanta, Georgia, United States, 30327
United States, Illinois
Univ of Illinois
Chicago, Illinois, United States, 60612
Chicago Ctr for Clinical Research
Chicago, Illinois, United States, 60610
United States, Indiana
Indiana Univ Med Ctr
Indianapolis, Indiana, United States, 46202
United States, New York
New York Univ Med Ctr
New York, New York, United States, 10016
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
Duke Univ
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States, 191021192
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Novum Inc
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002187     History of Changes
Other Study ID Numbers: 251D, ISIS 2922-CS9
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Antiviral Agents
Drug Administration Schedule
Cytomegalovirus Retinitis
fomivirsen
Vitreous Body

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Fomivirsen
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014