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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002356
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1998

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002356 on ClinicalTrials.gov Archive Site
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The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
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)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Fomivirsen sodium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002356
251C, ISIS 2922-CS7
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Isis Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
December 1998

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