Randomized, double-blind, placebo-controlled trial of the immune modulator WF10 in patients with advanced AIDS

Abstract

A randomized, double-blind trial compared treatment with the immune modulator WF10 (ten patients) and placebo (nine patients) administered in cycles over 3 months among individuals with advanced AIDS. There were no notable clinical adverse events; changes in hematologic and chemistry values were comparable in the two groups. In both groups, median HIV-RNA PCR values remained stable. Immunologic variables showed a consistent tendency to increase in the WF10 group and to decrease in the control group, with significant differences between groups for median WBC, lymphocyte, CD19, and CD35 values. Ten infections occurred in the control group, four of which were Pneumocystis carinii pneumonia (PCP), and three in the WF10 group none of which was PCP. Five patients in the control group were hospitalized during the trial for a total of 53 days; no patients in the WF10 group were hospitalized. Over a subsequent 9-months follow-up, six patients from the control group and one from the WF10 group died. These results indicate that WF10 administration appears safe, may enhance immunologic function, and unlike other macrophage-activating cytokines does not increase HIV expression in this patient population. Further studies of WF10 in larger patient populations are warranted.

Rapid Healing of Cutaneous Leishmaniasis by High-Frequency Electrocauterization and Hydrogel Wound Care with or without DAC N-055: A Randomized Controlled Phase IIa Trial in Kabul

“…During the past 30 years in vitro analyses, animal studies and clinical trials have shown that preparations of pharmaceutical NaClO 2 not only exerted antiviral and antimicrobial effects [31]–[34], but also promoted tissue regeneration and wound healing following radiation, chemotherapeutic, ischemic, metabolic, or infectious injuries [35]–[39]. Although the oxidative processes and molecular mechanisms underlying these findings have not yet been defined in detail, pharmaceutical NaClO 2 clearly promotes cell proliferation, hematopoiesis, and microcirculatory blood and oxygen supply, modulates the functions of immune cells, and limits inflammatory responses [40]–[44].…”

Balanced Macrophage Activation Hypothesis: A Biological Model for Development of Drugs Targeted at Macrophage Functional States

“…WF10 has been approved in Thailand for systemic administration to patients with postradiation syndrome and for supportive care in patients being treated for cancer. These indications have been studied extensively and reviewed [2]. Oxoferrin is used topically to enhance healing of chronic wounds such as diabetic ulcers [3].…”

Effects of WF10 on Glycosaminoglycan Sulphation in Proinflammatory Monocytes and Macrophages

“…Among the therapeutic approaches against inflammatory diseases is the intravenous infusion of the chlorite-based immunomodulatory drug solution WF10. This drug solution and the more diluted form Oxoferin have been successfully applied to dampen strong inflammatory states and to improve wound healing processes in patients [10][11][12][13]. However, the fine mechanism of the action of WF10 remains unknown.…”