Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT) (MACRT)
HIV Infections, Cytomegalovirus Retinitis
About this trial
This is an interventional treatment trial for HIV Infections
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MSL-109
Placebo
The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.
Placebo administered intravenous infusion every 2 weeks 60 mg.