Anti-human immunodeficiency virus (HIV) activity, safety, and pharmacokinetics of adefovir dipivoxil (9-[2-(bis-pivaloyloxymethyl)- phosphonylmethoxyethyl]adenine) in HIV-infected patients

P. Barditch-Crovo, J. Toole, C. W. Hendrix, K. C. Cundy, D. Ebeling, H. S. Jaffe, P. S. Lietman

Research output: Contribution to journalArticlepeer-review

Abstract

A randomized, double-blind, placebo-controlled, dose-escalation study of adefovir dipivoxil, an oral prodrug of adefovir, was conducted in 36 human immunodeficiency virus (HIV)-infected subjects to evaluate its anti-HIV activity, safety, and pharmacokinetics. Subjects received placebo or one of three dosages of adefovir dipivoxil daily for 14 days. Median decreases in serum p24 antigen of 31% (P = .02), 25% (P = .31), and 30% (P = .01) occurred in each drug-treated group, respectively, compared with an increase of 17% in the placebo group. Median decreases in serum HIV RNA of 0.4-0.6 log10 copies/mL occurred in the drug-treated groups (P = .03), compared with no change in the placebo group. Gastrointestinal complaints and reversible liver transaminase elevations were the most frequently noted adverse events. Decreases in serum free carnitine occurred in each drug-treated group during treatment. After 14 days of dosing, adefovir dipivoxil demonstrated anti-HIV activity and was best tolerated at the lowest dosage studied, 125 mg daily.

Original languageEnglish (US)
Pages (from-to)406-413
Number of pages8
JournalJournal of Infectious Diseases
Volume176
Issue number2
DOIs
StatePublished - 1997

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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