The purpose of this study was to characterise the epidemiological and the c
linical features of non-AIDS-defining neoplasms (NAN) in HIV-infected subje
cts in the era of highly active antiretroviral therapy (HAART). A retrospec
tive cohort of 4,041 subjects was established. Patients were recruited from
January 1989 to December 1998. We observed 51 NAN over the study period. T
he overall incidence rate was 0.21 per 100 person-years (PY) and it remaine
d stable, also after the introduction, in 1996 of HAART. Moreover, stratify
ing according to the type of neoplasms there was no statistically significa
nt difference in the incidence of NAN over the study period. While the epid
emiological features of NAN generally was not different from that observed
in immunocompetent individuals, the neoplasms had a more aggressive clinica
l course and a poor prognosis. Survival analysis showed that the presence o
f NAN significantly reduced the survival of patients with AIDS (P=0.01; OR=
0.62; 95% CI=0.47-0.96) compared with matched controls. The overall mortali
ty-rate was 63% with an incidence rate of 0.13 per 100 PY. Although the inc
idence rate of NAN is not of great magnitude, as the number of HIV-infected
individuals continues to increase and their survival improves, the number
of HIV-infected subjects with NAN might consequently increase as well as th
e related morbidity and mortality.