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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002156
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1998
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

Resource links provided by NLM:


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

Estimated Enrollment: 194
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.

  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 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.
  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: NCT00002156

Locations
United States, California
Retina - Vitreous Associates Med Group
Los Angeles, California, United States, 90017
Community Eye Med Group
Pasadena, California, United States, 911052536
San Diego Naval Hosp
San Diego, California, United States, 92134
Univ of California San Francisco / SF Gen Hosp
San Francisco, California, United States, 94110
Santa Clara Valley Med Ctr
San Jose, California, United States, 95128
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Florida
Dr Julio Perez
Fort Lauderdale, Florida, United States, 33060
United States, Georgia
Georgia Retina
Atlanta, Georgia, United States, 30327
United States, Illinois
Univ of Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Med Ctr
Indianapolis, Indiana, United States, 46202
United States, New York
Vitreo - Retinal Consultants
New York, New York, United States, 10028
United States, North Carolina
Charlotte Eye Ear Nose and Throat Association
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
Graduate Hosp
Philadelphia, Pennsylvania, United States, 191461192
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 752359057
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23507
United States, Washington
Novum Inc
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002156     History of Changes
Other Study ID Numbers: 251B, ISIS 2922-CS3
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:
AIDS-Related Opportunistic Infections
Ganciclovir
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antiviral Agents
Cytomegalovirus Retinitis
Injections

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

ClinicalTrials.gov processed this record on July 24, 2014