NCT00000118

Brief Summary

To determine the therapeutic efficacy of a sustained-release intraocular drug delivery system for ganciclovir therapy of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1992

Shorter than P25 for phase_3 hiv-infections

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

Study Start

First participant enrolled

October 1, 1992

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1993

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

September 23, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 1999

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

First QC Date

September 23, 1999

Last Update Submit

September 16, 2009

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeCytomegalovirus Retinitis

Interventions

Sustained-Release Intraocular Drug Delivery SystemDEVICE

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
All patients must have had AIDS as defined by the Centers for Disease Control and Prevention and non-sight-threatening CMV retinitis Patients could not have been previously treated with systemic ganciclovir or foscarnet and must not have had evidence of other organ involvement with CMV. Patients must have had an absolute neutrophil count (ANC) greater than 1,000 cells/mL and a platelet count greater than 25,000/mm3

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Martin DF, Parks DJ, Mellow SD, Ferris FL, Walton RC, Remaley NA, Chew EY, Ashton P, Davis MD, Nussenblatt RB. Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial. Arch Ophthalmol. 1994 Dec;112(12):1531-9. doi: 10.1001/archopht.1994.01090240037023.

    PMID: 7993207BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeCytomegalovirus Retinitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesEye Infections, ViralEye InfectionsCytomegalovirus InfectionsHerpesviridae InfectionsDNA Virus InfectionsEye DiseasesRetinitisRetinal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 23, 1999

First Posted

September 24, 1999

Study Start

October 1, 1992

Study Completion

December 1, 1993

Last Updated

September 17, 2009

Record last verified: 2009-09