Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Cytomegalovirus Retinitis
HIV Infections
Drug: Fomivirsen sodium
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: 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)

Resource links provided by NLM:


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

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.

  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.
  • 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.
  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: NCT00002356

  Show 25 Study Locations
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002356     History of Changes
Other Study ID Numbers: 251C, ISIS 2922-CS7
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:
Acquired Immunodeficiency Syndrome
Antiviral Agents
Cytomegalovirus Retinitis

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

ClinicalTrials.gov processed this record on November 20, 2014