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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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