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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002134
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1997
  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: Endpoint Classification: Safety Study
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

Resource links provided by NLM:


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

Estimated Enrollment: 450
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
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
Saint Clare's Prof Office
New York, New York, United States, 10019
Vitreo - Retinal Consultants
New York, New York, United States, 10028
Dr Dorothy Friedberg
New York, New York, United States, 10016
New York Hosp
New York, New York, United States, 10021
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

Publications:
ClinicalTrials.gov Identifier: NCT00002134     History of Changes
Other Study ID Numbers: 037B, GANS2304
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:
Retinitis
Ganciclovir
Administration, Oral
Acquired Immunodeficiency Syndrome

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

ClinicalTrials.gov processed this record on October 23, 2014