A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002355
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1998
  Purpose

To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Fomivirsen sodium

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus (CMV) Retinitis

Resource links provided by NLM:


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

Estimated Enrollment: 60
Detailed Description:

In Stage 1 (dose escalation), patients receive either 75 or 150 mcg intravitreal ISIS 2922. In Stage 2 (randomization), patients are enrolled in either the immediate treatment group or delayed treatment group. Immediate treatment consists of intravitreal ISIS 2922 every 7 days for 3 injections (Induction) then every 14 days for 18 weeks (Maintenance). Patients in the delayed treatment group receive no immediate anti-CMV treatment but are monitored weekly for disease progression. If disease progresses, patient receives ISIS 2922 on an identical dosage regimen as those on immediate treatment. Patients may continue ISIS 2922 on a biweekly extended maintenance schedule if dose is considered safe and the CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

  Eligibility

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

Inclusion Criteria

Patients must have:

  • AIDS.
  • Clinical diagnosis of previously untreated peripheral CMV retinitis in one eye.
  • Leading edge of a CMV retinitis lesion is at least 750 microns from zone one. NOTE:
  • Patients with CMV retinitis in zone three only may be eligible if the lesions can be reliably photographed to follow progression.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions in the eye to be treated are excluded:

  • External ocular infections.
  • Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
  • Ocular conditions that will obstruct visualization of the posterior ocular structures.
  • Retinal detachment.
  • Silicone oil in eye.

Patients with the following other symptoms or conditions are excluded:

  • Known or suspected allergy to phosphorothioate oligonucleotides.
  • Syphilis.
  • Pseudoretinitis pigmentosa.

Concurrent Medication:

Excluded:

  • Current treatment for extra-ocular CMV infection.
  • Ganciclovir.
  • Foscarnet.
  • Mellaril.
  • Stelazine.
  • Thorazine.
  • Clofazimine.
  • Ethambutol/fluconazole combination.
  • Investigational medications for CMV retinitis.

Concurrent Treatment:

Excluded:

  • Investigational procedures for CMV retinitis.

Patients with the following prior conditions are excluded:

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

Prior Medication:

Excluded:

  • Prior anti-CMV retinitis treatment in either eye.
  • Anti-CMV therapy for extra-ocular infection within the past 2 days.
  Contacts and Locations
Choosing 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: NCT00002355

Locations
United States, California
Retina - Vitreous Associates Med Group
Los Angeles, California, United States, 90017
Community Eye Med Group
Pasadena, California, United States, 911052536
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, 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
United States, Indiana
Indiana Univ Med Ctr
Indianapolis, Indiana, United States, 46202
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
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 752359057
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23507
United States, Washington
Novum Inc
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002355     History of Changes
Other Study ID Numbers: 251A, ISIS 2922-CS2
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
Acquired Immunodeficiency Syndrome
Antiviral Agents
Cytomegalovirus Retinitis

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
Molecular Probes
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on August 18, 2014