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

June 23, 2005 updated by: Ionis Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Irvine, California, United States, 92715
        • UCI College of Medicine
      • Los Angeles, California, United States, 90017
        • Retina - Vitreous Associates Med Group
      • Pasadena, California, United States, 911052536
        • Community Eye Med Group
      • San Diego, California, United States, 92134
        • San Diego Naval Hosp
      • San Francisco, California, United States, 94110
        • Univ of California San Francisco / SF Gen Hosp
      • San Jose, California, United States, 95128
        • Santa Clara Valley Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • Dr Alan Palestine
    • Florida
      • Fort Lauderdale, Florida, United States, 33060
        • Dr Julio Perez
      • Miami, Florida, United States, 33136
        • Bascon Palmer Eye Institute
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Georgia Retina
      • Atlanta, Georgia, United States, 30322
        • Emory Univ School of Medicine / Emory Eye Ctr
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Med Ctr
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ
    • New York
      • New York, New York, United States, 10028
        • Vitreo - Retinal Consultants
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Charlotte Eye Ear Nose & Throat Association
      • Durham, North Carolina, United States, 27710
        • Duke Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Hahnemann Univ Hosp
      • Philadelphia, Pennsylvania, United States, 191461192
        • Graduate Hosp
    • Texas
      • Dallas, Texas, United States, 752359057
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77004
        • Vitreoretinal Consultants
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Eye Consultants
    • Washington
      • Seattle, Washington, United States, 98104
        • Novum Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 1998

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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