Combined therapy with zidovudine, recombinant granulocyte colony stimulating factors and erythropoietin in asymptomatic HIV patients.

The aim of this randomized, comparative, double-blind study was to determine the efficacy of zidovudine (ZVD) either alone or in combination with recombinant granulocyte-colony stimulating factors (rG-CSF) and erythropoietin (Epo) in asymptomatic HIV-infected subjects with a CD4+ cell count < 500/mm(3), classified as CDC II stage. We recruited 20 HIV Ab+ asymptomatic patients who were randomized into two groups : A and B. Group A was treated with ZVD at the dosage of 500 mg daily in combination with rG-CSF (10 mu g/Kg/biweekly) and Epo (50 IU/Kg/biweekly). Group B was treated with ZVD (500 mg/day) alone. The primary end-point was progression to an AIDS-defining event and the secondary end-point included changes in the CD4+ cell count, p24 Ag status, beta-2-microglobulin, and ferritin levels. The patients of Group A showed no significant changes in transaminase, ferritin and beta-2-microglobulin levels while CD4 cells, Hb and neutrophil levels increased significantly compared to Group B (p < 0.001) and baseline values (p < 0.05). Conversely, 5 patients in Group B showed a significant decrease in CD4 cells (p < 0.01), Hb and neutrophil levels (p < 0.01) compared to baseline values, while beta-2-microglobulin increased (p < 0.05) compared to initial values. Our preliminary study may indicate that the combination of zidovudine with these hematopoietic growth factors could reduce the possibility of virus-related hematologic toxicity and could be more efficacious than zidovudine alone in prolonged therapy.