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The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002356
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
Official Title  ICMJE 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)
Brief Summary

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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cytomegalovirus Retinitis
  • HIV Infections
Intervention  ICMJE Drug: Fomivirsen sodium
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Patients must have:

  • AIDS.
  • CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.
  • Intolerance or resistance to other therapies.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • 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.
  • Syphilis.
  • Clinical evidence of retinal pigment epithelial stippling.
  • Pseudoretinitis pigmentosa.

Concurrent Medication:

Excluded:

  • Foscarnet.
  • Mellaril, Stelazine, Thorazine, and Clofazimine.
  • Ethambutol / fluconazole combination.
  • Other investigational drugs for CMV retinitis.

Patients with the following prior conditions are excluded:

  • 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.

Required:

  • Prior CMV retinitis therapy with ganciclovir, foscarnet, or ISIS 2922.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002356
Other Study ID Numbers  ICMJE 251C
ISIS 2922-CS7
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ionis Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date December 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP