Studies of the Ocular Complications of AIDS (SOCA). Monoclonal Antibody CMVRetinitis Trial (MACRT) Forms and Charts Notebook

摘要

The document is the study manual for the Human Anti-CMV Monclonal Antibody MSL109 Trial (MACRT). The trial was a mutlicenter, phase II/III, randomized controlled clinical trial conducted by the studies of Ocular Complications of AIDS (SOCA) in collaboration with the AIDS Clinical Trials Group (ACTG protocol number 294). The study was designed to evaluate the safety and efficacy of human anti-CMV monoclonal antibody in comparison with matched placebo plus active primary treatment, for both newly dianosed and relapsed CMV retinitis patients with AIDS. The trial had a two-stage group sequential design, and an evaluation of the interim results by the Policy and Data Monitoring Board after the enrollment of the first stage patients and their followup for 24 weeks was planned a priori. The two treatment groups consisted of 60 mg MSL 109 intravenously every 2 weeks, concurrent with active primary treatment for CMV retinitis; and a matched placebo for MSL 109 every 2 weeks, concurrent with active primary treatment for CMV retinitis. Treatment groups were randomly allocated in a 1:1 ratio. The outcome measures included mortality, retinitis progression, and change in visual acuity and visual fields.