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A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Ganciclovir, Cytomegalovirus Infections, 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: Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy. ddI. ddC. Patients must have: Confirmed HIV infection or diagnosis of AIDS. CMV retinitis of no more than 4 months duration. Stable retinitis. Understanding of the nature of the study, agree to its provisions, and sign informed consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Persistent or clinically significant diarrhea (3 or more unformed stools/day), nausea, or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal disease. Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment. Ocular conditions requiring immediate surgical correction (e.g., retinal tear or detachment). Dementia, decreased mentation, or other encephalopathic signs and symptoms that would interfere with the ability of the subject to give informed consent or comply with the protocol. Concurrent Medication: Excluded: Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance therapy. Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected cytokines. Patients with the following prior conditions are excluded: Diagnosis of CMV retinitis more than 4 months prior to study entry. More than two prior induction treatments of IV ganciclovir (initial induction and one re-induction are permitted). Prior Medication: Excluded: More than two induction treatment regimens with IV ganciclovir. Prior oral ganciclovir (in Groups A, B, and C only).

Sites / Locations

  • East Bay AIDS Ctr
  • AIDS Clinical Research Ctr / UCLA Med Ctr
  • UCSD Med Ctr / Pediatrics
  • San Francisco Gen Hosp
  • Davies Med Ctr / c/o HIV Institute
  • Mount Zion Med Ctr
  • Dr David Busch
  • Georgetown Univ Med Ctr
  • Miami Veterans Administration Med Ctr
  • AIDS Research Consortium of Atlanta
  • Margo Heath - Chiozzi
  • Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
  • Beth Israel Hosp
  • Dr Dorothy Friedberg
  • Cornell Univ Med College
  • Buckley Braffman Stern Med Associates
  • Oak Lawn Physicians Group
  • Univ TX Galveston Med Branch
  • Univ of Washington / Pacific Med Ctr
  • Saint Paul's Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00002247
Brief Title
A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
Official Title
A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 1993
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
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
To compare the safety and tolerance of oral ganciclovir at a double dose 3 times/day or a single dose 6 times/day to IV ganciclovir given for 20 weeks of maintenance therapy. To compare the time to progression of cytomegalovirus (CMV) retinitis between two regimens of oral ganciclovir and IV ganciclovir therapy given for 20 weeks of maintenance therapy. To describe the efficacy and safety of double dose versus single dose oral ganciclovir in patients who have a progression of retinitis while on the originally assigned maintenance treatment. To describe the safety, tolerance, and time to progression of retinitis during the 52 weeks of oral ganciclovir maintenance therapy in people with AIDS. To describe the safety and tolerance of oral ganciclovir maintenance therapy when given concurrently with antiretroviral treatment (e.g., zidovudine, ddI, or ddC). To describe survival of people with AIDS and CMV retinitis.
Detailed Description
Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A, B, and C of the study, provided that each subject has received and tolerated a therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in stable retinitis. An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral ganciclovir sponsored by Syntex Research and have stable retinitis may enter into Group D of this study and receive oral 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, Cytomegalovirus Infections, Administration, Oral, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
225 (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: Zidovudine except during the first 2 weeks of any oral or IV ganciclovir maintenance therapy. ddI. ddC. Patients must have: Confirmed HIV infection or diagnosis of AIDS. CMV retinitis of no more than 4 months duration. Stable retinitis. Understanding of the nature of the study, agree to its provisions, and sign informed consent. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Persistent or clinically significant diarrhea (3 or more unformed stools/day), nausea, or abdominal pain or other gastrointestinal symptoms or uncontrolled gastrointestinal disease. Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic retinal assessment. Ocular conditions requiring immediate surgical correction (e.g., retinal tear or detachment). Dementia, decreased mentation, or other encephalopathic signs and symptoms that would interfere with the ability of the subject to give informed consent or comply with the protocol. Concurrent Medication: Excluded: Zidovudine during the first 2 weeks of any oral or IV ganciclovir maintenance therapy. Antimetabolites. Alkylating agents. Selected nucleoside analogs. Selected cytokines. Patients with the following prior conditions are excluded: Diagnosis of CMV retinitis more than 4 months prior to study entry. More than two prior induction treatments of IV ganciclovir (initial induction and one re-induction are permitted). Prior Medication: Excluded: More than two induction treatment regimens with IV ganciclovir. Prior oral ganciclovir (in Groups A, B, and C only).
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
AIDS Clinical Research Ctr / UCLA Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951793
Country
United States
Facility Name
UCSD Med Ctr / Pediatrics
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Davies Med Ctr / c/o HIV Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Mount Zion Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dr David Busch
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Margo Heath - Chiozzi
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr / Rush Med Coll
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Beth Israel Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dr Dorothy Friedberg
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cornell Univ Med College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Oak Lawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Univ of Washington / Pacific Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
Facility Name
Saint Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
9110064
Citation
Danner SA, Matheron S. Cytomegalovirus retinitis in AIDS patients: a comparative study of intravenous and oral ganciclovir as maintenance therapy. AIDS. 1996 Dec;10 Suppl 4:S7-11.
Results Reference
background

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A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

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