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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Roche Global Development


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002134

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: July 1997
History of Changes
Purpose

Purpose

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.

Condition Intervention
Cytomegalovirus Retinitis
HIV Infections

Drug : Ganciclovir

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

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

Enrollment: 450

Detailed Description:

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

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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).

contacts and locations

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: NCT00002134

Locations

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

Sponsors and Collaborators

Roche Global Development
More Information

More Information


Responsible Party: Roche Global Development  
ClinicalTrials.gov Identifier: NCT00002134   History of Changes  
Other Study ID Numbers: 037B  
  GANS2304  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Retinitis
Ganciclovir
Administration, Oral
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Retinitis
Cytomegalovirus Retinitis
Ganciclovir
Ganciclovir triphosphate

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.