Randomized, placebo-controlled trial of product R, a peptide-nucleic acid immunomodulator, in the treatment of adults infected with HIV.
| Autor: | Levett PN; University of the West Indies School of Clinical Medicine and Research, Queen Elizabeth Hospital, Bridgetown, Barbados., Hirschman SZ, Roach TC, Broome H, Alexander RJ, Fraser HS |
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| Jazyk: | angličtina |
| Zdroj: | HIV clinical trials [HIV Clin Trials] 2002 Jul-Aug; Vol. 3 (4), pp. 272-8. |
| DOI: | 10.1310/N34A-653T-ABF5-8Q1R |
| Abstrakt: | 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. |
| Databáze: | MEDLINE |
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