CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 209 enrolled
Drug / intervention
MSL-109 +1 moredrug
Likely dose
MSL-109 60 mg IV every 2 weeksAI-extracted
Key inclusion· 7
  • ✓13 years or older
  • ✓AIDS diagnosis per CDC definition
  • ✓Active CMV retinitis confirmed by SOCA-certified ophthalmologist at enrollment
  • ✓At least one retinitis lesion ≥0.25 optic disc area
Key exclusion· 4
  • ✕Current treatment with IVIG, CMV-IG, alpha-IFN, gamma-IFN, or IL-2
  • ✕Media opacity preventing fundal visualization in all eligible eyes
  • ✕Retinal detachment not scheduled for surgical repair in all eligible eyes
  • ✕Active medical problems (drug/alcohol abuse, etc.) hindering compliance with treatment/follow-up

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

Search/NCT00000135
NCT00000135Phase 3Completed
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Monoclonal Antibody CMV Retinitis Trial (MACRT)

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

In Brief

A Phase 3 clinical trial evaluating MSL-109 and Placebo for HIV Infections and Cytomegalovirus Retinitis. Completed, enrolled 209 participants.

Detailed Summary

To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Cytomegalovirus Retinitis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 1999
Enrollment StartSep 1, 1995
Primary CompletionAug 1, 1996
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 26.8 years ago

Interventions

MSL-109drug

60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.

Placeboother

60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.