A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
1 other identifier
interventional
N/A
2 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 1997
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedMay 17, 2017
July 1, 2005
5.9 years
November 2, 1999
May 15, 2017
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Documented AIDS diagnosis
- Newly diagnosed peripheral CMV retinitis
- More than 3 weeks of previous therapy for CMV retinitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Univ of California / Irvine
Irvine, California, 92697, United States
Univ of California / San Diego / Dept of Pediatrics
La Jolla, California, 92093, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 92103, United States
Davies Med Ctr / Institute for HIV Research
San Francisco, California, 94114, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
QUEST Clinical Research
San Francisco, California, 94115, United States
Dr Alan Palestine
Washington D.C., District of Columbia, 20006, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Emory Eye Clinic
Atlanta, Georgia, 30322, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
New York Univ Med Ctr
New York, New York, 10016, United States
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
New York, New York, 10019, United States
New York Hosp - Cornell Med Ctr
New York, New York, 10021, United States
Duke Univ Eye Ctr
Durham, North Carolina, 27710, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
St Pauls Hosp
Vancouver, British Columbia, Canada
The Toronto Hosp / Dept of Infectious Disease
Toronto, Ontario, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
Royal Victoria Hosp
Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
January 1, 1997
Primary Completion
December 1, 2002
Study Completion
December 1, 2002
Last Updated
May 17, 2017
Record last verified: 2005-07