NCT00000894

Brief Summary

To compare cidofovir with a commonly used treatment regimen, ganciclovir given by mouth (oral) and through an eye device (intraocular) , in order to determine the safety and effectiveness of cidofovir in preventing vision loss in patients who have AIDS complicated by CMV (cytomegalovirus) retinitis. Cidofovir needs to be compared to ganciclovir to determine the best way to treat CMV retinitis.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

12 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

February 23, 2011

Status Verified

June 1, 2003

First QC Date

November 2, 1999

Last Update Submit

February 22, 2011

Conditions

Keywords

Infusions, IntravenousGanciclovirDrug Therapy, CombinationAdministration, OralAntiviral AgentsDrug ImplantsCytomegalovirus RetinitisEyecidofovir

Interventions

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • You may be eligible for this study if you:
  • Are 13 years of age or older (parent or guardian consent required if under 18).
  • Agree to practice sexual abstinence or use effective birth control during and for 90 days after the study.
  • Have AIDS.
  • Have CMV retinitis.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Have a history of heart or kidney disease.
  • Have medical problems which would prevent you from completing the study.
  • Are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

UCLA CARE Ctr

Los Angeles, California, 90095, United States

Location

Univ of Miami / Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Emory Eye Clinic

Atlanta, Georgia, 30322, United States

Location

Northwestern Univ / SOCA

Chicago, Illinois, 60611, United States

Location

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

New York Hosp / Cornell Med Ctr

New York, New York, 10021, United States

Location

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Texas Galveston

Galveston, Texas, 775550435, United States

Location

MeSH Terms

Conditions

Cytomegalovirus RetinitisHIV InfectionsMultiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

CidofovirProbenecidGanciclovir

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 DiseasesAmino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCytosinePyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesSulfonesSulfur CompoundsAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Primary Completion

June 1, 2000

Last Updated

February 23, 2011

Record last verified: 2003-06

Locations