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.


METHODS
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.


CONCLUSIONS
These findings suggest that Product R may have efficacy in the treatment of HIV-infected individuals.
University of the West Indies School of Clinical Medicine and Research, Queen Elizabeth Hospital, Bridgetown, Barbados.
Paul N
PN
Levett
Shalom Z
SZ
Hirschman
Timothy C
TC
Roach
Hedy
H
Broome
Richard J
RJ
Alexander
Henry S
HS
Fraser
D017088:AIDS-Related Opportunistic Infections; D000276:Adjuvants, Immunologic / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D018655:Lymphocyte Count; D008297:Male; D020135:Peptide Nucleic Acids / Q000494:pharmacology / Q000627:therapeutic use*; D010919:Placebos; D011897:Random Allocation; D019562:Viral Load; D015430:Weight Gain / Q000187:drug effects
D000276:Adjuvants, Immunologic; C469610:EOM613; D020135:Peptide Nucleic Acids; D010919:Placebos