Phase-1 studies of malariotherapy for HIV infecton.

Objective: To determine whether malariotherapy (an old therapy for treatment of neurosyphilis) improves some clinical and laboratory parameters of HIV-positive patients without iatrogenic complications.

Methods: Total 8 asymptomatic HIV-1 positive subjects whose CD4 cell counts were over 250 x 10(6) cells/L were selected for the phase-1 studies of malariotherapy and were intravenously injected Plasmodia vivax to induce artificial malaria. Malaria was terminated with chloroquine after 10 to approximately 20 malarial fever episodes. Cell-bound CD4 levels were measured by APAAP (a solid-phase enzyme essay) and levels of neopterin (NPT), beta-2-microglobulin (B2M), soluble tumor necrosis factor receptor-2 (sTNF-RII), interleukin-2 (IL-2) and HIV P24 antigen were measured by ELISA. Patients were followed up to 24 to approximately 30 months.

Results: CD4 levels increased in 5, NPT decreased in 7 of 8 patients; IL-2 increased in 5 of 6 patients after malariotherapy. The total trends of B2M and sTNF-RII basically remained stable. HIV P24 antigen remained undetectable in 6, remained detectably low level in 1 and experienced increase in 1 of 8 patients after malariotherapy. No any severe complications occurred in all 8 patients.

Conclusions: The results indicate that malariotherapy basically is safe for HIV infection and it seems that the therapy improves some immunological parameters of HIV patients.