CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Cidofovir intravenous +1 moredrug
Likely dose
Ganciclovir implant with oral ganciclovir 1 g three times daily, or cidofovir intravenous 5 mg/kg once weekly for two doses, then 5 mg/kg every other weekAI-extracted
Key inclusion· 6
  • ✓Age 13 years or older
  • ✓AIDS diagnosis per CDC definition
  • ✓Active CMV retinitis confirmed by SOCA-certified ophthalmologist
  • ✓Best corrected visual acuity 20/100 or better in at least one eye
Key exclusion· 3
  • ✕Media opacities that prevent fundus visualization in otherwise eligible eyes
  • ✕Prior ganciclovir intraocular implant within 9 months of study entry
  • ✕Medical problems or substance abuse that would prevent adherence to treatment or follow-up

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT00000143Phase 3Completed
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Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Sep 24, 1999·Updated Mar 14, 2016

In Brief

A Phase 3 clinical trial evaluating Ganciclovir implant and oral ganciclovir and Cidofovir intravenous for Cytomegalovirus Retinitis and HIV Infections. Completed, enrolled 61 participants across 19 sites.

Detailed Summary

To compare the newest CMV retinitis drug, cidofovir, with a regimen of the ganciclovir intraocular device plus oral ganciclovir with respect to efficacy in preventing vision loss. To compare a treatment regimen that incorporates highly active local therapy (ganciclovir device) with a treatment regimen that does not.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Retinitis, HIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 1999
Enrollment StartMay 1, 1997
Primary CompletionJun 1, 2000
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 26.8 years ago

Interventions

Ganciclovir implant and oral ganciclovirdevice

oral ganciclovir, 1 gm three times daily

Cidofovir intravenousdrug

intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week