Authors: M. Gordon, B. Bihari, E. Goosby, R. Gorter, M. Greco, M. Guralnik, T. Mimura, V. Rudinicki, R. Wong, Y. Kaneko
Journal: Journal of Medical Virology
Study Design: Two-phase I/II placebo-controlled trials
Participants: 98 HIV-positive patients
Intervention:
- San Francisco General Hospital (SFGH) study: 10 patients each received 2, 5, or 10 mg of lentinan or placebo intravenously once a week for 8 weeks
- Community Research Initiative in New York (CRI) study: 20 patients each received 1 or 5 mg of lentinan intravenously twice a week for 12 weeks, and 10 patients received placebo twice a week
Outcome Measures:
- Safety and tolerability of lentinan
- Changes in CD4 cell counts
- Changes in neutrophil activity
- Changes in p24 antigen levels (in a subset of patients)
Summary: The study evaluated the safety and potential efficacy of lentinan, an immune modulator, in HIV-positive patients. The results showed that lentinan was generally well-tolerated, with most side effects being mild and resolving quickly. The study also observed a trend towards increases in CD4 cell counts and neutrophil activity in some patients, although these changes were not statistically significant due to the small sample size. In a subset of patients with elevated p24 antigen levels, a decrease in p24 was observed in both lentinan and placebo groups, with some marked decreases in the lentinan group. The authors concluded that lentinan is safe and may have positive effects on certain immune markers in HIV-positive patients, warranting further investigation in larger clinical trials. A subsequent trial combining lentinan with didanosine showed a mean increase in CD4 cells over 12 months, further supporting the potential of lentinan as an adjunctive therapy for HIV.
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