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document
MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome : the Monoclonal Antibody Cytomegalovirus Retinitis Trial . The Studies of Ocular Complications of AIDS Research Group . AIDS Clinical Trials Group . OBJECTIVE To evaluate the efficacy and safety of an intravenous human monoclonal antibody to cytomegalovirus ( CMV ) , MSL-109 , as adjuvant treatment for CMV retinitis . METHODS Two hundred nine patients with acquired immunodeficiency syndrome and active CMV retinitis were enrolled in a multicenter , phase 2/3 , randomized , placebo-controlled clinical trial . Patients received adjuvant treatment with MSL-109 , 60 mg intravenously every 2 weeks , or placebo . Randomization was stratified on the basis of whether patients had untreated or relapsed retinitis . Primary drug therapy for CMV retinitis was determined by the treating physician . RESULTS The rates of retinitis progression , as evaluated in a masked fashion , were 3.04/person-year in the MSL-109-treated group and 3.05/person-year in the placebo-treated group ( P=.98 ; Wald test ) ; the median times to progression were 67 days in the MSL-109-treated group and 65 days in the placebo-treated group . No differences between the 2 groups were noted in the rates of increase in retinal area involved by CMV , visual field loss , or visual acuity outcomes . The mortality rate in the MSL-109-treated group was 0.68/person-year , and in the placebo-treated group , 0.31/person-year ( P=.01 ) . The mortality difference was not explained by differences in baseline variables or in concurrent antiretroviral therapy . Among patients with newly diagnosed retinitis , mortality rates were similar ( MSL-109 , 0.41/person-year ; placebo , 0.42/person-year ; P=.95 ) , whereas among patients with relapsed retinitis the MSL-109-treated group had a greater mortality rate ( MSL-109 , 0.83/person-year ; placebo , 0.24/person-year ; P=.003 ) . However , the mortality rate in the placebo-treated patients with relapsed CMV retinitis was lower than that in the placebo-treated patients with newly diagnosed CMV retinitis and lower than that in other trials of patients with relapsed CMV retinitis . CONCLUSIONS Intravenous MSL-109 , 60 mg every 2 weeks , appeared to be ineffective adjuvant therapy for CMV retinitis . The mortality rate was higher in the MSL-109-treated group , but the reasons for this difference remain uncertain .
90957
Intervention_Pharmacological
MSL-109 adjuvant therapy
90958
Intervention_Pharmacological
MSL-109
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Intervention_Control
placebo-controlled
90960
Intervention_Pharmacological
MSL-109
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Intervention_Control
placebo
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Intervention_Pharmacological
Primary drug therapy
90963
Intervention_Pharmacological
MSL-109-treated
90964
Intervention_Control
placebo-treated
90965
Intervention_Pharmacological
MSL-109-treated
90966
Intervention_Pharmacological
MSL-109-treated
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Intervention_Control
placebo-treated
90968
Intervention_Pharmacological
MSL-109-treated
90969
Intervention_Pharmacological
MSL-109
90970
Intervention_Control
placebo
90971
Intervention_Control
placebo-treated
90972
Intervention_Pharmacological
MSL-109
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Intervention_Pharmacological
MSL-109-treated
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Outcome_Other
efficacy and safety
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Outcome_Physical
rates of retinitis progression
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Outcome_Physical
rates of increase in retinal area involved by CMV , visual field loss , or visual acuity outcomes
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Outcome_Mortality
mortality rate
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Outcome_Mortality
mortality
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Outcome_Mortality
mortality rates
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Outcome_Mortality
mortality rate
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Outcome_Mortality
mortality rate
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Outcome_Other
ineffective
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Outcome_Mortality
mortality rate
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Participant_Condition
cytomegalovirus retinitis
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Participant_Condition
Ocular Complications
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Participant_Sample-size
Two hundred nine
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Participant_Condition
acquired immunodeficiency syndrome
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Participant_Condition
CMV retinitis