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

May 15, 2017 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1997

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

July 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WV15376

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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