Phase 3
N=209
Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
HIV Infections · Cytomegalovirus Retinitis
Bottom Line
View on ClinicalTrials.gov: NCT00000135 ↗Enrolled (actual)
209
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Mortality Rate — 0.68; 0.31 deaths per person-year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MSL-109 (Drug); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Aug 1996
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality Rate |
0.68; 0.31 | — |
Summary
To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.
Eligibility Criteria
Inclusion criteria
- 13 years or older at entry
- Diagnosis of AIDS according to the Centers for Disease Control and Prevention (CDC) definition
- Diagnosis of active CMV retinitis as determined by a SOCA-certified ophthalmologist at time of enrollment
- At least one lesion whose size is one-quarter or more optic disc area
- Currently receiving (for relapsed patients) or scheduled to receive (for newly diagnosed patients) drugs for primary treatment of CMV retinitis that are not contraindicated for use with MSL-109
- Visual acuity, in at least one eye that meets other eligibility criteria, of 3 or more letters on ETDRS chart at 1 meter distance (Snellen equivalent 5/200). Patients with poorer visual acuity may be enrolled if the visual acuity impairment is possibly reversible (eg, due to optic disc edema) and vision is at least light perception in that eye
- Karnofsky score of 60 or more
- Willingness and ability, with the assistance of a caregiver if necessary, to comply with treatment and follow up procedures
- signed consent statement
Exclusion criteria
- Current treatment with intravenous immune globulin (IVIG), CMV immune globulin (CMVIG), alpha-interferon (alpha-IFN), gamma-interferon (gamma-IFN) or interleukin-2 (IL-2)
- Media opacity that precludes visualization of the fundus in all eyes meeting eligibility criteria
- Active medical problems, including drug or alcohol abuse, that are considered sufficient to hinder compliance with treatment or follow up procedures
- Retinal detachment, not scheduled for surgical repair, in all eyes meeting other eligibility criteria
Data sourced from ClinicalTrials.gov (NCT00000135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.