Back to resultsA Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
Primary Purpose
Cytomegalovirus Retinitis, HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Valganciclovir
Ganciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Cytomegalovirus Retinitis
Eligibility Criteria
Inclusion Criteria: Documented AIDS diagnosis Newly diagnosed peripheral CMV retinitis More than 3 weeks of previous therapy for CMV retinitis
Sites / Locations
- Univ of California / Irvine
- Univ of California / San Diego / Dept of Pediatrics
- Univ of California / San Diego Treatment Ctr
- Davies Med Ctr / Institute for HIV Research
- Kaiser Permanente Med Ctr
- QUEST Clinical Research
- Dr Alan Palestine
- Univ of Miami School of Medicine
- Emory Eye Clinic
- New England Med Ctr
- New York Univ Med Ctr
- St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
- New York Hosp - Cornell Med Ctr
- Duke Univ Eye Ctr
- Austin Infectious Disease Consultants
- St Pauls Hosp
- The Toronto Hosp / Dept of Infectious Disease
- Montreal Chest Institute
- Royal Victoria Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002377
Brief Title
A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
January 1997 (Actual)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the pharmacokinetics of ganciclovir following administration of RS-79070 in the target population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented AIDS diagnosis
Newly diagnosed peripheral CMV retinitis
More than 3 weeks of previous therapy for CMV retinitis
Facility Information:
Facility Name
Univ of California / Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Univ of California / San Diego / Dept of Pediatrics
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Univ of California / San Diego Treatment Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Davies Med Ctr / Institute for HIV Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Kaiser Permanente Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
QUEST Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dr Alan Palestine
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20006
Country
United States
Facility Name
Univ of Miami School of Medicine
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
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Hosp - Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke Univ Eye Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Austin Infectious Disease Consultants
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St Pauls Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
The Toronto Hosp / Dept of Infectious Disease
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Chest Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Royal Victoria Hosp
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
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