THE SAFETY AND EFFICACY OF ADEFOVIR DIPIVOXIL, A NOVEL ANTI-HUMAN-IMMUNODEFICIENCY-VIRUS (HIV) THERAPY, IN HIV-INFECTED ADULTS - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Adefovir dipivoxil is a novel nucleotide analogue with several promisi ng in vitro anti-human immunodeficiency virus (HIV) characteristics. T o evaluate the safety and efficacy of adefovir dipivoxil monotherapy, a randomized, double-blind, placebo-controlled study was initiated inv olving 72 subjects with moderately advanced HIV disease. Subjects were randomly assigned in a 2:1 ratio to receive adefovir dipivoxil or pla cebo as a once-daily oral dose for 6 weeks, followed by 6 weeks of ope n-label adefovir dipivoxil, Two dose levels were studied (125 mg and 2 50 mg), Adefovir dipivoxil was determined to be safe and well-tolerate d when administered for 12 weeks. At week 6, changes in absolute CD4 T cell levels and HIV-I RNA levels were significantly greater with adef ovir dipivoxil than with placebo, These effects were sustained through 12 weeks of treatment, As determined by standard RNA sequencing techn iques, only 1 of the 24 subjects who received adefovir dipivoxil (125 mg/day) developed any genotypic change from baseline.