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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002377
First Posted: August 31, 2001
Last Update Posted: May 17, 2017
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
November 2, 1999
August 31, 2001
May 17, 2017
January 1997
December 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002377 on ClinicalTrials.gov Archive Site
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A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
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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.
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Interventional
Phase 3
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
  • Drug: Valganciclovir
  • Drug: Ganciclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2002
December 2002   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented AIDS diagnosis
  • Newly diagnosed peripheral CMV retinitis
  • More than 3 weeks of previous therapy for CMV retinitis
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00002377
WV15376
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Hoffmann-La Roche
Hoffmann-La Roche
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Not Provided
Hoffmann-La Roche
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP