Figure 1.

Participant flow in AMC-072. *Four patients were enrolled in error: No treatment per protocol criteria (n = 1), HPV vaccine prior to screening (n = 1), AIN 3 on screening (n = 1), not on HAART for 90 days prior to entry (n = 1). **One patient withdrew/refused prior to beginning protocol therapy. Abbreviations: AE, adverse event; alc, alcohol; AMC, AIDS Malignancy Consortium; AIN, Anal intraepithelial neoplasia; ANC, Absolute neutrophil count; HAART, highly active antiretroviral therapy; HPV, human papillomavirus; LTFU, lost to follow-up.