ABSTRACT
This study aims to evaluate the in vivo antiviral, immunologic, clinical effects and safety of a supposedly anti-HIV phytotherapy, code-named R019 used for the treatment of HIV/AIDS. This is an open observational study, which involved 32 HIV-1 infected patients, who were followed over a 3-month period. The efficacy evaluation was based on CD4 count, determination of viral load and clinical status. The safety evaluation was based on renal and liver function tests, fasting lipid and glycaemia levels as well as the frequency of other adverse events. The CD4 values increased significantly (mean±SD, 99.03±22.87 cells/μL; P<0.001), as well as Weight and Karnofsky score (2.94±0.67 kg, p<0.001; 4.9, p=0.005 respectively). The viral load decreased significantly (0.91±0.12 log viral load, P<0.0001). R019 did not impair renal or liver functions. Improvement of creatinine clearance was observed (p=0.02). Hemoglobin levels increased (0.38±0.16 gr/dL) whereas cholesterol and glucose levels decreased under R019 treatment (p=0.031, p=0.018 respectively). Main adverse effects were recorded: polyuria (40.5%), drowsiness (21.4%), orexis (19.1%). Immunological, anti-viral and clinical status improved under R019 treatment and a good safety profile was observed for this compound. Further studies would be required to optimize its efficacy and to define its appropriateness for the treatment of HIV disease.