Available medications that target the HIV-1 enzymes, reverse transcriptase and protease inhibitors, demonstrate significant reductions in HIV-1 RNA, and delay clinical disease progress and mortality. The authors comment that despite the success, new modalities of treatment are needed to expand the benefits conferred by anti-HIV therapy. Treatments that affect the immunologic system to reduce disease progress are needed. WF10 contains a chemically stabilized chloride matrix. It is an immune modulator with activity due to its ability to modulate macrophages and affect immune activation. This study was initiated to evaluate the safety of WF10 and its effect on red blood cell survival, macrophage and monocyte activity and immune function in HIV infected adults, conferring increased ability to fight off bacterial, fungi, and mycobacterial pathogens.

The study enrolled HIV infected patients with CD4 cells above 50 with less than 20,000 HIV-1 copies/mL and normal laboratory safety values. Ten of the patients had CD4 cells above 300 and eight had CD4 cells below 300. Ten subjects had less than 500 copies of viral RNA by DNA methods.

WF10 was administered as a sterile intravenous infusion at a dose of 0.5 mL/kg diluted in 250-500 mL normal saline. Seventeen patients in total received two courses of WF10. The fifty-one C RBC counts decreased at a steady rate but there were no obviously hemolytic episodes and reticulocyte counts did not reveal any hemolytic activity. There were local reactions including asthenia, dizziness, photophobia, altered taste sensation, diarrhea and headache.

The conclusions of this study were that:

1. WF10 does not cause hemolysis.

2. WF10 is well-tolerated with some infusion site reactions.

3. WF10 is safe for administration to HIV infected individuals.

4. WF10 administration caused changes in measurable immune parameters including critical T cell subsets such as CD28, CD38 and total CD8 numbers, reflecting down regulation of immune activation which is believed in HIV disease to be inappropriately elevated.

5. The increase in phagocytic index in patients whose baseline phagocytic activity and CD4 count were low, may be used for prevention of opportunistic infections.

The significance of this study lies in its exploration of a new modality of treatment. It is not yet clear that this will be a productive avenue, although on the basis of this data, clearly further evaluation is warranted. Clinical implications, I think, are too early to comment on, but this is another encouraging contribution to the database accumulating concerning immunomodulation in addition to antiretroviral agents in the therapy of HIV infection.