Effect of Immunomodulating and Antiviral Agent of Medicinal Mushrooms (Immune Assist 24/7TM) on CD4+ T-Lymphocyte Counts of HIV-Infected Patients Gideon Adotey,1 Abraham Quarcoo,1 John C. Holliday,2* Solomon Fofie,3 & Braimah Saaka3 1Science Laboratory Department, Accra Polytechnic, Accra, Ghana; 2Aloha Medicinals Inc., Carson City, NV, USA; 3Sunyani Regional Hospital, Sunyani, Brong-Ahafo, Ghana *Address all correspondence to John C. Holliday, Aloha Medicinals Inc., 2300 Arrowhead, Carson City, NV 89706, USA; john@alohamedicinals.com ABSTRACT: Immune enhancement through the use of natural products is a potentially valuable therapeutic modality in HIV-infected people, especially those who are not good candidates for aggressive ARV therapy. One such immune enhancement, a medicinal mushroom product from the United States, is Immune Assist 24/7™. In this study the effect of Immune Assist 24/7™, which is a naturally derived immune-modulating and antiviral agent, on CD4+ T-lymphocyte counts was evaluated in 8 HIV-infected patients at the Sunyani Regional Hospital (Ghana). The subjects were administered three tablets of 800 mg Immune Assist 24/7™ once daily (2.4 g/day) and peripheral blood samples were drawn at baseline, day 30, and day 60, and the CD4+ count measured. The study revealed that Immune Assist 24/7™, used as a sole therapeutic agent without additional ARV drugs, significantly increased CD4+ T-lymphocyte populations in all of the patients. In one patient, the CD4+ T-lymphocyte count went from 4 at the baseline, to 170 cells in 60 days, representing an increase of more than 4000%. In another patient, the CD4+ count went from 88 to 470 cells within the same period. Even in the patients with the highest CD4+ counts of around 800, there was a significant elevation in the CD4+ count noted. This study did not deal with the effect of Immune Assist 24/7™ on other immune parameters such as CD3+ T-lymphocyte count, natural killer cells count, or viral load among HIV-infected patients. These initial results are promising, and indicate the potential value of further evaluating the effects of Immune Assist 24/7™ on other immune parameters and viral load among HIV patients, administered either as a sole therapeutic agent, as an adjuvant with standard ARV therapy, or in comparison with standard ARV therapy alone. KEY WORDS: medicinal mushrooms, immunomodulating activity, antiviral, HIV-infected patients, CD4+ T-lymphocyte, natural killer cells, Lentinus edodes, Grifola frondosa, Ganoderma lucidum, Trametes versicolor, Agaricus brasiliensis, Immune Assist 24/7™ ABBREVIATIONS: AIDS, acquired immune deficiency syndrome or acquired immunodeficiency syndrome; ARV, antiretroviral; cART, combination antiretroviral therapy; CD4, co-receptor that assists the T cell receptor; EGCG, epigallocatechin gallate; ELISA, enzyme-linked immunosorbent assay; HIV, human immunodeficiency virus; NK cells, natural killer cells; TCR, T cell receptor