CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 279 enrolled
Drug / intervention
Ganciclovir +1 moredrug
Likely dose
Ganciclovir intravenous induction 5 mg/kg twice daily for 2 weeks, then maintenance 10 mg/kg/day; or Foscarnet intravenous induction 90 mg/kg twice daily for 2 weeks, then maintenance 120 mg/kg/dayAI-extracted
Key inclusion· 6
  • ✓Age 18 years or older
  • ✓Diagnosis of AIDS and CMV retinitis
  • ✓Active CMV retinitis despite minimum 28 days of prior anti-CMV drug treatment
  • ✓Absolute neutrophil count ≥500 cells/µL
Key exclusion· 6
  • ✕History of intolerance to ganciclovir or foscarnet
  • ✕Prior therapy with combination of foscarnet and ganciclovir
  • ✕Unwillingness to practice appropriate birth control
  • ✕Active drug or alcohol abuse

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

Search/NCT00000134
NCT00000134Phase 3Completed
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Cytomegalovirus Retinitis Retreatment Trial

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Sep 24, 1999·Updated Sep 14, 2015

In Brief

A Phase 3 clinical trial evaluating Ganciclovir and Foscarnet for HIV Infections and 2 related conditions. Completed, enrolled 279 participants.

Detailed Summary

To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Acquired Immunodeficiency Syndrome, Cytomegalovirus Retinitis
Countries--
CollaboratorsNational Eye Institute (NEI), National Institute of Allergy and Infectious Diseases (NIAID), Johns Hopkins University, University of Wisconsin, Madison, Baylor College of Medicine, Tulane University School of Medicine, Icahn School of Medicine at Mount Sinai, New York Presbyterian Hospital, New York University, Northwestern University, University of California, Los Angeles, University of California, San Francisco, University of California, San Diego, University of Miami, University of North Carolina, Chapel Hill, Memorial Sloan Kettering Cancer Center

Timeline

Phase 3CompletedFinished
199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 1999
Enrollment StartDec 1, 1992
Primary CompletionMar 1, 1995
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 26.8 years ago

Interventions

Ganciclovirdrug

intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day

Foscarnetdrug

intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day