| Abstract: |
AL 721, a lipid mixture with reported in vitro activity against human immunodeficiency virus (HIV) via cell membrane or virion cholesterol depletion, was evaluated in a multicenter, open-label, dose-ranging trial. Forty men with persistent generalized lymphadenopathy or AIDS-related complex were treated with doses of 20, 30, 40, or 50 g orally twice daily for 8 weeks, and monitored for toxicity, disease progression, and with immunologic, virologic, and serum lipid profiles. The compound was found to be well tolerated over the broad range of doses examined; adverse reactions were confined to the gastrointestinal tract, of mild to moderate severity, and self-limited in duration. Modest weight gains observed on treatment were reversed within 4 weeks following cessation of therapy. While disease progression was not observed in this short-term study, we could find no indication of an immunorestorative or antiviral effect of AL 721, as determined by T-lymphocyte subset quantitation or HIV culture. All three patients who were HIV p24 antigenemic at entry retained positive antigen levels throughout treatment. As a consequence of therapy, however, significant increases in serum lipids were observed, including elevations in both triglycrride and total cholesterol levels. In conclusion, our experience on the largest group of HIV-infected patients treated with the highest doses of AL 721 provides no support for the use of this compound as an antiretroviral agent. © 1991 Raven Press, New York. |
| Keywords: |
adult; clinical article; controlled study; drug efficacy; drug safety; nonhuman; human immunodeficiency virus infection; drug administration schedule; body weight; antivirus agent; human immunodeficiency virus; t-lymphocyte subsets; phosphatidylethanolamines; drug combinations; lymphadenopathy; clinical trials; hiv; oral drug administration; antiviral agents; multicenter studies; lipoproteins, hdl; lipoproteins, ldl; aids related complex; phosphatidylcholines; human; male; article; support, non-u.s. gov't; support, u.s. gov't, p.h.s.; aids-related complex; al 721; persistent generalized lymphadenopathy; glycerides
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