Controlled Trial of a New Non-Toxic Drug, Reticulose, in the Treatment of Patients with HIV/AIDS Paul Levett University of West Indies School of Clinical Medicine and Research Queen Elizabeth Hospital Barbados 246-427-5586 Paper A-263, Session 252-A A trial of this new treatment for HIV/AIDS suggests that it can stimulate the immune system to produce increased CD4 cells without an accompanying rise in HIV viral load. Patients who received Reticulose also gained weight and their clinical condition improved compared to controls. The study was conducted by a team from the University of the West Indies School of Clinical Medicine & Research at the Queen Elizabeth Hospital in Barbados. The team included Dr. Paul N. Levett (clinical microbiologist), Dr. Timothy C. Roach (internal medicine specialist) Dr. Henry S. Fraser (internal medicine specialist), and Ms. Hedy Broome (biostatistician) in collaboration with Dr. Shalom Z. Hirschman, New York-based infectious diseases specialist. Dr. Hirschman is President and CEO of Advanced Viral Research Corp. Yonkers, NY, which manufactures Reticulose and which supported the study. The first presentation of data from this study is to be made at the 98th General Meeting of the American Society for Microbiology, in Atlanta, Georgia, on Thursday, May 21, 1998. A total of 43 patients with HIV-1 infection, who had never received anti-retroviral therapy, were randomized to receive either Reticulose (21 patients) or placebo (22 patients), at a dosage of two 1ml subcutaneous (SC) injections per day for two weeks, followed by 1ml SC per day every other week for a total of 60 days (total 30 days treatment). There were no toxic effects observed in, or reported by, patients receiving Reticulose. In patients with HIV-1 infection, treatment with Reticulose produced an early rise in CD4 counts, with no accompanying rise in plasma HIV RNA levels during this limited period f observation. There were improved clinical outcomes, including weight gain, fewer opportunistic infections and lower mortality in patients who received Reticulose. These findings, and the low cost of Reticulose, could have major implications for alternative treatments for the global patient population with HIV/AIDS. Reticulose is a peptide nucleic acid which acts as an immunomodulator, stimulating the production of cytokines. Other viral infections for which trials of Reticulose are presently underway include hepatitis B and human papillomavirus (HPV).

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