CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
Cidofovirdrug
Likely dose
Cidofovir 5 mg/kg once weekly for 2 weeks, then 3 mg/kg once every 2 weeks (low-dose); or 5 mg/kg once weekly for 2 weeks, then maintenance (high-dose—amount not specified)AI-extracted
Key inclusion· 7
  • ✓AIDS diagnosis per CDC criteria
  • ✓Age ≥13 years
  • ✓CMV retinitis confirmed by SOCA-certified ophthalmologist with lesion ≥1/4 disc area
  • ✓Visual acuity ≥8/200 (ETDRS) in affected eye
Key exclusion· 11
  • ✕CMV lesion in zone 1 (within 1500 µ of optic disc margin or 3000 µ of foveal center)
  • ✕CMV lesion involving ≥25% of retinal area
  • ✕Retinal detachment in affected eye(s)
  • ✕Media opacity precluding fundus visualization in both eyes

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

Search/NCT00000142
NCT00000142Phase 3Completed
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Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Sep 24, 1999·Updated Nov 17, 2015

In Brief

A Phase 3 clinical trial evaluating Cidofovir for HIV Infections and CMV Cytomegalovirus Retinitis. Completed, enrolled 64 participants.

Detailed Summary

To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously known as HPMPC) for the treatment of retinitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, CMV Cytomegalovirus Retinitis
Countries--
CollaboratorsBaylor College of Medicine, Johns Hopkins University, Louisiana State University Health Sciences Center in New Orleans, Icahn School of Medicine at Mount Sinai, New Jersey Medical School, 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 North Carolina, Chapel Hill, University of South Florida

Timeline

Phase 3CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 1999
Enrollment StartApr 1, 1994
Primary CompletionFeb 1, 1996
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 26.8 years ago

Interventions

Cidofovirdrug

Three groups: 1. the deferral group, treatment deferred until retinitis progressed 2. Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks. 3. High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.