A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes

This study has been completed.
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: November 2, 1999
Last updated: July 1, 2005
Last verified: July 2005
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.

Condition Intervention Phase
Cytomegalovirus Retinitis
HIV Infections
Drug: Valganciclovir
Drug: Ganciclovir
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:


Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented AIDS diagnosis
  • Newly diagnosed peripheral CMV retinitis
  • More than 3 weeks of previous therapy for CMV retinitis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002377

United States, California
Univ of California / Irvine
Irvine, California, United States, 92697
Univ of California / San Diego / Dept of Pediatrics
La Jolla, California, United States, 92093
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 92103
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Davies Med Ctr / Institute for HIV Research
San Francisco, California, United States, 94114
QUEST Clinical Research
San Francisco, California, United States, 94115
United States, District of Columbia
Dr Alan Palestine
Washington, District of Columbia, United States, 20006
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Emory Eye Clinic
Atlanta, Georgia, United States, 30322
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
United States, New York
New York Univ Med Ctr
New York, New York, United States, 10016
St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
New York, New York, United States, 10019
New York Hosp - Cornell Med Ctr
New York, New York, United States, 10021
United States, North Carolina
Duke Univ Eye Ctr
Durham, North Carolina, United States, 27710
United States, Texas
Austin Infectious Disease Consultants
Austin, Texas, United States, 78705
Canada, British Columbia
St Pauls Hosp
Vancouver, British Columbia, Canada
Canada, Ontario
The Toronto Hosp / Dept of Infectious Disease
Toronto, Ontario, Canada
Canada, Quebec
Montreal Chest Institute
Montreal, Quebec, Canada
Royal Victoria Hosp
Montreal, Quebec, Canada
Sponsors and Collaborators
Hoffmann-La Roche
  More Information

ClinicalTrials.gov Identifier: NCT00002377     History of Changes
Other Study ID Numbers: WV15376 
Study First Received: November 2, 1999
Last Updated: July 1, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cytomegalovirus Retinitis
Cytomegalovirus Infections
DNA Virus Infections
Eye Diseases
Eye Infections
Eye Infections, Viral
Herpesviridae Infections
Retinal Diseases
Virus Diseases
Ganciclovir triphosphate
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016