A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis

June 23, 2005 updated by: Roche Global Development
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.

Study Type

Interventional

Enrollment

450

Phase

  • Not Applicable

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

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Dr Neil Brourman
      • Irvine, California, United States, 92715
        • UCI College of Medicine
      • Los Angeles, California, United States, 90033
        • Estelle Doheny Eye Clinic
      • Sacramento, California, United States, 95819
        • Dr Robert T Wendel
      • San Francisco, California, United States, 94115
        • Pacific Horizons Med Group
      • San Francisco, California, United States, 94115
        • Kaiser Hosp
      • San Jose, California, United States, 95128
        • Santa Clara Valley Med Ctr
      • Santa Barbara, California, United States, 93103
        • Dr Robert Avery
      • Torrance, California, United States, 90509
        • Harbor - UCLA Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • Dr Alan Palestine
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Dr Michael Stewart
      • Miami, Florida, United States, 33136
        • Bascom Palmer
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Eye Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Dr David Weinberg
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky Med Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Med Ctr / Tufts Univ
    • New York
      • New York, New York, United States, 10016
        • Dr Dorothy Friedberg
      • New York, New York, United States, 10019
        • Saint Clare's Prof Office
      • New York, New York, United States, 10021
        • New York Hosp
      • New York, New York, United States, 10028
        • Vitreo - Retinal Consultants
    • Texas
      • Dallas, Texas, United States, 75235
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Seattle, Washington, United States, 98195
        • Univ of Washington Med Ctr

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

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Topical drugs and ophthalmics.

Patients must have:

  • AIDS.
  • Unilateral CMV retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
  • Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
  • Acute retinal necrosis or any other intraocular condition that might preclude study completion.
  • Ocular condition requiring immediate surgery.
  • Unable to have long-term IV catheter placement.

Concurrent Medication:

Excluded:

  • Vidarabine.
  • Amantadine hydrochloride.
  • Cytarabine.
  • FIAC or FIAU.
  • Idoxuridine.
  • Ribavirin.
  • Valacyclovir.
  • Foscarnet.
  • CMV hyperimmune globulin.
  • Soluble CD4.
  • Trichosanthin.
  • Imipenem-cilastatin.
  • Isoprinosine.
  • Levamisole.
  • Interferon.
  • Other investigational drugs.

Patients with the following prior conditions are excluded:

  • History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
  • History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

  • Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
  • Prior intravitreal ganciclovir implant.
  • More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
  • Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).

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

Collaborators and Investigators

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

Sponsor

Roche Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 037B
  • GANS2304

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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