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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

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
Roche Global Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Dr Neil Brourman
  • UCI College of Medicine
  • Estelle Doheny Eye Clinic
  • Dr Robert T Wendel
  • Kaiser Hosp
  • Pacific Horizons Med Group
  • Santa Clara Valley Med Ctr
  • Dr Robert Avery
  • Harbor - UCLA Med Ctr
  • Dr Alan Palestine
  • Dr Michael Stewart
  • Bascom Palmer
  • Emory Eye Clinic
  • Dr David Weinberg
  • Univ of Kentucky Med Ctr
  • New England Med Ctr / Tufts Univ
  • Dr Dorothy Friedberg
  • Saint Clare's Prof Office
  • New York Hosp
  • Vitreo - Retinal Consultants
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Baylor College of Medicine
  • Univ of Washington Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Roche Global Development
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1. Study Identification

Unique Protocol Identification Number
NCT00002134
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Roche Global Development

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
450 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Dr Neil Brourman
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UCI College of Medicine
City
Irvine
State/Province
California
ZIP/Postal Code
92715
Country
United States
Facility Name
Estelle Doheny Eye Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Dr Robert T Wendel
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Kaiser Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pacific Horizons Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Dr Robert Avery
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Dr Alan Palestine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Dr Michael Stewart
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Bascom Palmer
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory Eye Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Dr David Weinberg
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Univ of Kentucky Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
New England Med Ctr / Tufts Univ
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Dr Dorothy Friedberg
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Saint Clare's Prof Office
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Vitreo - Retinal Consultants
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of Washington Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11363508
Citation
Cheng B. Guide to CMV management. PI Perspect. 1996 Apr;(no 18):13-4.
Results Reference
background

Learn more about this trial

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

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