Randomized, placebo-controlled trial of product R, a peptide-nucleic acid immunomodulator, in the treatment of adults infected with HIV.

Objective: The efficacy of Product R, a nontoxic peptide-nucleic acid, was tested in 43 HIV-infected adults naïve to antiretroviral therapy.

Method: Patients were randomized to receive Product R (21 patients) or placebo (22 patients). Dosage was two 1 mL subcutaneous injections daily on days 1-14, followed by 1 mL daily on days 22-28, 36-42, and 50-56. The follow-up period lasted until day 120.

Results: Mean root CD4 count increased in the Product R group during treatment and was significantly higher (p =.013) by the end of follow-up. Four Product R-treated patients, but none of the control patients, experienced declines in viral load of >0.5 log. At the end of follow-up, the Product R group experienced a mean weight increase (p =.003), whereas the placebo group experienced a mean weight loss. The number of deaths and opportunistic infections were lower in the Product R group than in the placebo group (p =.076). No toxic effects were observed in any of the patients administered Product R.

Conclusion: These findings suggest that Product R may have efficacy in the treatment of HIV-infected individuals.