||This study aims to evaluate the in vivo antiviral, immunologie, clinical effects and
safety of a supposedly anti-HIV phytotherapy, code-named ROl9 used for the treatment of
HIV/AIDS. This is an open observational study, which involved 32 HIV-I infected patients,
who were followed over a 3-month period. The efficacy evaluation was based on CD4 count,
determination of viral 10ad and c1inical status. The safety eva1uation was based on renal and
liver function tests, fasting lipid and glycaemia levels as weil as the frequency of other adverse
events. The CD4 values increased significantly (mean±SD, 99.03±22.87 cellsl~l; P<O.OOI), as
weil as Weight and Karnofsky score (2.94±O.67 kg, p<O.OOI; 4.9, p=O.005 respectively). The
viral load decreased significantly (O.91±O.12 log viral load, P<O.OOO 1). RO 19 did not impair
renal or liver functions. Improvement of creatinine clearance was observed (p=O.02).
Hemoglobin levels increased (0.38±O.l6 gr/dl) whereas cholesterol and glucose levels
decreased under R019 treatinent (p=O.031, p=O.018 respectively). Main adverse effects were
recorded: polyuria (40.5%), drowsiness (21.4%), orexis (19.1%). Immunological, anti-viral and
c1inical status improved under RO 19 treatment and a good safety profile was observed for this
compound. Further studies wouId he required to optimize its efficacy and to define its
appropriateness for the treatment of HIV disease.