ClinicalTrials.gg
CompletedNCT00002377Updated May 17, 2017

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

A Phase 3 interventional study of Valganciclovir and Ganciclovir in Cytomegalovirus Retinitis and HIV Infections, sponsored by Hoffmann-La Roche. Completed at 19 sites in 2 countries. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 1997, registered Nov 1999).
Phase
Phase 3
Study type
Interventional
Ages
14 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cytomegalovirus Retinitis
  • HIV Infections
03

In context

Cytomegalovirus Retinitis

64 studies on the registry are indexed under Cytomegalovirus Retinitis; 2 are open to participants now.

Browse Cytomegalovirus Retinitis studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 88 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Documented AIDS diagnosis
  • Newly diagnosed peripheral CMV retinitis
  • More than 3 weeks of previous therapy for CMV retinitis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Intervention model
Parallel assignment

Interventions

06

Study locations

19 sites
  • Univ of California / Irvine
    Irvine, California 92697, United States
  • Univ of California / San Diego / Dept of Pediatrics
    La Jolla, California 92093, United States
  • Univ of California / San Diego Treatment Ctr
    San Diego, California 92103, United States
  • Davies Med Ctr / Institute for HIV Research
    San Francisco, California 94114, United States
  • Kaiser Permanente Med Ctr
    San Francisco, California 94115, United States
  • QUEST Clinical Research
    San Francisco, California 94115, United States
  • Dr Alan Palestine
    Washington D.C., District of Columbia 20006, United States
  • Univ of Miami School of Medicine
    Miami, Florida 33136, United States
  • Emory Eye Clinic
    Atlanta, Georgia 30322, United States
  • New England Med Ctr
    Boston, Massachusetts 02111, United States
  • New York Univ Med Ctr
    New York, New York 10016, United States
  • St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
    New York, New York 10019, United States
  • New York Hosp - Cornell Med Ctr
    New York, New York 10021, United States
  • Duke Univ Eye Ctr
    Durham, North Carolina 27710, United States
  • Austin Infectious Disease Consultants
    Austin, Texas 78705, United States
  • St Pauls Hosp
    Vancouver, British Columbia, Canada
  • The Toronto Hosp / Dept of Infectious Disease
    Toronto, Ontario, Canada
  • Montreal Chest Institute
    Montreal, Quebec, Canada
  • Royal Victoria Hosp
    Montreal, Quebec, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002377
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Aug 31, 2001
Start date
Jan 1997
Primary completion
Dec 2002
Completion
Dec 2002
Last update
May 17, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Valganciclovir · Ganciclovir

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