NCT00002222

Brief Summary

The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis in patients who have been treated for this condition in the past. This study also examines the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Cytomegalovirus RetinitisHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsGanciclovirAntiviral AgentsDrug Administration ScheduleCytomegalovirus RetinitisProdrugs

Interventions

ValganciclovirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed with caution:
  • Acyclovir.
  • Famciclovir.
  • Valaciclovir.
  • Imipenem-cilastatin.
  • Myelosuppressive agents.
  • Patients must have:
  • HIV infection with CMV retinitis.
  • Minimum of 4 weeks prior treatment with ganciclovir, foscarnet, or cidofovir.
  • Intraocular implant in either or both eyes, as long as CMV retinitis is active in one eye, upon approval by Roche.

You may not qualify if:

  • Co-existing Condition:
  • Patients with any of the following symptoms of conditions are excluded:
  • Active extraocular CMV disease.
  • Severe uncontrolled diarrhea or evidence of malabsorption.
  • Concurrent Medication:
  • Excluded:
  • Foscarnet.
  • Cidofovir.
  • CMV hyperimmune globulin.
  • Probenecid.
  • Patients with the following prior conditions are excluded:
  • Ocular media opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment.
  • Simultaneous participation in another study (unless approved by Roche).
  • Required:
  • A minimum of 4 weeks treatment with ganciclovir, foscarnet, or cidofovir.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell AIDS Clinical Trials Unit

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cytomegalovirus RetinitisHIV InfectionsAIDS-Related Opportunistic InfectionsMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Eye Infections, ViralEye InfectionsInfectionsCytomegalovirus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesEye DiseasesRetinitisRetinal DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Intervention Hierarchy (Ancestors)

GanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-04

Locations

US(1)