An open-label, dose-ranging trial of AL 721 in patients with persistent generalized lymphadenopathy and AIDS-related complex.

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 triglyceride 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.

• Authors: D Mildvan, J Buzas, D Armstrong, D Antoniskis, H S Sacks, F S Rhame, E W Mosbach, C Pettinelli
• Journal: Journal of acquired immune deficiency syndromes (J Acquir Immune Defic Syndr (1988)) Vol. 4 Issue 10 Pg. 945-51 ( 1991) ISSN: 0894-9255 [Print] United States
• PMID: 1890604 (Publication Type: Clinical Trial, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antiviral Agents
• Drug Combinations
• Glycerides
• Lipoproteins, HDL
• Lipoproteins, LDL
• Phosphatidylcholines
• Phosphatidylethanolamines
• neutral lipid, phosphatidylcholine, phosphatidylethanolamine drug combination

Topics

• AIDS-Related Complex (drug therapy, microbiology, physiopathology)
• Antiviral Agents (adverse effects, therapeutic use)
• Body Weight (drug effects)
• Clinical Trials as Topic
• Drug Administration Schedule
• Drug Combinations
• Glycerides (adverse effects, therapeutic use)
• Humans
• Lipoproteins, HDL (blood)
• Lipoproteins, LDL (blood)
• Male
• Multicenter Studies as Topic
• Phosphatidylcholines (adverse effects, therapeutic use)
• Phosphatidylethanolamines (adverse effects, therapeutic use)
• T-Lymphocyte Subsets (drug effects)