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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.
 
ClinicalTrials.gov Identifier: NCT00002377
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : May 17, 2017
Sponsor:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00002377


Locations
Show Show 19 study locations
Sponsors and Collaborators
Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00002377    
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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Valganciclovir
Cytomegalovirus Retinitis
Retinitis
Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action