CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 234 enrolled
Drug / intervention
Foscarnet +1 moredrug
Likely dose
Foscarnet 60 mg/kg every 8 hours (90 mg/kg/day) or Ganciclovir 5 mg/kg every 12 hours (or 5 mg/kg every 24 hours)AI-extracted
Key inclusion· 7
  • ✓CMV retinitis in one or both eyes
  • ✓At least 1/4 disk area of one CMV lesion photographable
  • ✓AIDS diagnosis per CDC criteria or documented HIV infection
  • ✓Age 13 or older
Key exclusion· 4
  • ✕Prior treatment of CMV retinitis
  • ✕Anti-CMV therapy for extra-ocular CMV infection currently or within past 28 days
  • ✕Known or suspected allergy to study drugs
  • ✕Pregnant or lactating

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

Search/NCT00000136
NCT00000136Phase 3Completed
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Foscarnet-Ganciclovir CMV Retinitis Trial

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Sep 24, 1999·Updated Oct 22, 2015

In Brief

A Phase 3 clinical trial evaluating Foscarnet and Ganciclovir for HIV Infections and Cytomegalovirus Retinitis. Completed, enrolled 234 participants.

Detailed Summary

To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Cytomegalovirus Retinitis
Countries--
CollaboratorsNational Eye Institute (NEI), Johns Hopkins University, University of Wisconsin, Madison, Baylor College of Medicine, Louisiana State University Health Sciences Center in New Orleans, New York Presbyterian Hospital, Icahn School of Medicine at Mount Sinai, NYU Langone Health, Northwestern University, University of California, Los Angeles, University of California, San Diego, University of California, San Francisco, University of Miami, University of Massachusetts, Worcester, Memorial Sloan Kettering Cancer Center

Timeline

Phase 3CompletedFinished
19901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 1999
Enrollment StartMar 1, 1990
Primary CompletionOct 1, 1991
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 26.8 years ago

Interventions

Foscarnetdrug

60 mg/kg every 8 hours, 90 mg/kg/day

Ganciclovirdrug

5 mg/kg every 12 hours, 5 mg/kg every 24 hours