Completed
A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes
What is being tested
Valganciclovir
+ Ganciclovir
Drug
Who is being recruted
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
Over 14 Years
+3 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: January 1997
Summary
Principal SponsorHoffmann-La Roche
Last updated: May 17, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 1997
Actual date on which the first participant was enrolled.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.
Principal SponsorHoffmann-La Roche
Last updated: May 17, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 14 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesCytomegalovirus InfectionsDNA Virus InfectionsEye DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetinal DiseasesRetinitisRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsHIV InfectionsCytomegalovirus Retinitis
Criteria
3 inclusion criteria required to participate
Documented AIDS diagnosis
More than 3 weeks of previous therapy for CMV retinitis
Newly diagnosed peripheral CMV retinitis
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 19 locations
Univ of California / San Diego / Dept of Pediatrics
La Jolla, United StatesUniv of California / San Diego Treatment Ctr
San Diego, United StatesDavies Med Ctr / Institute for HIV Research
San Francisco, United StatesCompleted19 Study Centers