The Body Covers: The 39th Annual Meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy
Session 93.I: Late-Breaker Slide Session II
September 27, 1999
Dr. Kahn reported on the phase III trial of Remmune, an HIV-1 immunogen, studied with a background of ARV therapy. The study was begun in March, 1996 and recruited 2700 patients by 5/97 at 77 sites. Patients were randomized to get Remmune or IFA (background adjuvant) in a 1:1 ratio.Abstract: A Randomized, Placebo-Controlled Multicenter Study of Remmune in Subjects With 300-550 CD4 Cells and Unrestricted Antiretroviral Treatments (Paper LB-21)
Fortunately for the patients, but unfortunately for the study, HAART became available during this period. The original study was designed to look at clinical progression or death and the data safety monitoring board found that with the change in patient status brought about by HAART, the study would take far too long and require far too many patients to detect a statistically significant difference between arms. Therefore the study was terminated.
Authored by: J. Kahn, et al.
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