Cytomegalovirus Retinitis, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Antibodies, Monoclonal, Cytomegalovirus Retinitis
Brief summary
To compare the safety and efficacy of sevirumab (MSL 109; Protovir), human anti-cytomegalovirus (CMV) monoclonal antibody, plus active primary treatment versus placebo plus active primary treatment in AIDS patients with newly diagnosed and relapsed CMV retinitis. Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis.
Detailed description
Ganciclovir and foscarnet are used for treatment of CMV retinitis, but cause hematologic toxicity and nephrotoxicity, respectively. Despite continued maintenance therapy with these drugs, relapse occurs in 85 percent of patients within 4 months. Studies suggest that MSL 109, a human monoclonal antibody, when given with either ganciclovir or foscarnet, may increase initial response and prolong time to progression in patients with CMV retinitis. Patients are randomized to receive either MSL 109 or placebo every 2 weeks as supplemental therapy to primary CMV treatment.
Interventions
DRUGSevirumab
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Required: * Primary CMV treatment. Patients must have: * AIDS. * Active CMV retinitis. * At least one photographable lesion of one-quarter or more optic disc area in size. * Undergoing primary treatment for CMV retinitis that is not contraindicated with MSL 109. * Visual acuity in at least one eye of 3 or more letters on Early Treatment Diabetic Retinopathy Study ( ETDRS ) chart at 1 meter distance ( Snellen equivalent 5/200 ). Note: * Exceptions may be made if visual acuity impairment is possibly reversible and there is at least light perception in that eye.
Exclusion criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Retinal detachment not scheduled for surgical repair. * Media opacity that precludes visualization of the fundus. * Active medical problems sufficient to hinder study compliance. Concurrent Medication: Excluded: * IVIG. * CMV immune globulin ( CMVIG ). * Interferon alpha. * Interferon gamma. * Interleukin-2 ( IL-2 ). Drug or alcohol abuse sufficient to hinder study compliance.
Countries
United States
Outcome results
None listed