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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002377
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 17, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Retinitis HIV Infections Drug: Valganciclovir Drug: Ganciclovir Phase 3

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Actual Study Start Date : January 1997
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented AIDS diagnosis
  • Newly diagnosed peripheral CMV retinitis
  • More than 3 weeks of previous therapy for CMV retinitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002377

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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
Davies Med Ctr / Institute for HIV Research
San Francisco, California, United States, 94114
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
QUEST Clinical Research
San Francisco, California, United States, 94115
United States, District of Columbia
Dr Alan Palestine
Washington, D.C., 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

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Responsible Party: Hoffmann-La Roche Identifier: NCT00002377     History of Changes
Other Study ID Numbers: WV15376
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: July 2005

Additional relevant MeSH terms:
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HIV Infections
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action