A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

June 23, 2005 updated by: Ionis Pharmaceuticals, Inc.
To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.

Study Overview

Detailed Description

In Stage 1 of the study, 20 patients receive one of two doses of ISIS 2922 on days 1, 8, and 15 (Induction) then every 14 days (maintenance), with ganciclovir given daily during both Induction and Maintenance. Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose (day 29). In Stage 2 of the study, 174 patients are randomized to receive either a) ISIS 2922 at the dose established in Stage 1 on days 1, 8, and 15 and then every 14 days, with ganciclovir given daily during both Induction and Maintenance, or b) ganciclovir daily for 14 consecutive days and then a lower dose as maintenance. Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

Study Type

Interventional

Enrollment

194

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
      • 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
    • Florida
      • Fort Lauderdale, Florida, United States, 33060
        • Dr Julio Perez
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Georgia Retina
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Med Ctr
    • New York
      • New York, New York, United States, 10028
        • Vitreo - Retinal Consultants
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Charlotte Eye Ear Nose and Throat Association
    • 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
    • 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 that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
  • No more than one previous progression of CMV retinitis.

Exclusion Criteria

Co-existing Condition:

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

  • External ocular infection.
  • Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
  • Ocular condition 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.
  • Retinal pigment epithelial stippling not associated with CMV retinitis.
  • Pseudoretinitis pigmentosa.
  • Chronic diarrhea that would impair absorption of oral ganciclovir.
  • Intolerance to ganciclovir.

Concurrent Medication:

Excluded:

  • Foscarnet or other anti-CMV agents other than ganciclovir.
  • 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 eye to be treated.
  • History of intolerance to ISIS 2922.

Prior Medication:

Excluded:

  • Prior ganciclovir implant for CMV retinitis.
  • More than 4 months of prior ganciclovir.

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

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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