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 promising in vitro anti-human immunodeficiency virus (HIV) characteristics. To evaluate the safety and efficacy of adefovir dipivoxil monotherapy, a randomized, double-blind, placebo-controlled study was initiated involving 72 subjects with moderately advanced HIV disease. Subjects were randomly assigned in a 2:1 ratio to receive adefovir dipivoxil or placebo as a once-daily oral dose for 6 weeks, followed by 6 weeks of open-label adefovir dipivoxil. Two dose levels were studied (125 mg and 250 mg). Adefovir dipivoxil was determined to be safe and well-tolerated when administered for 12 weeks. At week 6, changes in absolute CD4 T cell levels and HIV-1 RNA levels were significantly greater with adefovir dipivoxil than with placebo. These effects were sustained through 12 weeks of treatment. As determined by standard RNA sequencing techniques, only 1 of the 24 subjects who received adefovir dipivoxil (125 mg/day) developed any genotypic change from baseline.
Deeks
S G
SG
University of California, San Francisco, San Francisco General Hospital, 94110, USA.
Collier
A
A
Lalezari
J
J
Pavia
A
A
Rodrigue
D
D
Drew
W L
WL
Toole
J
J
Jaffe
H S
HS
Mulato
A S
AS
Lamy
P D
PD
Li
W
W
Cherrington
J M
JM
Hellmann
N
N
Kahn
J
J
D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000284:Administration, Oral; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D002331:Carnitine / Q000097:blood; D003587:Cytomegalovirus / Q000187:drug effects / Q000235:genetics; D003586:Cytomegalovirus Infections / Q000821:virology; D004279:DNA, Viral / Q000032:analysis / Q000235:genetics; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D009154:Mutation; D063065:Organophosphonates; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000032:analysis / Q000097:blood / Q000235:genetics; D012661:Semen / Q000821:virology; D017423:Sequence Analysis, RNA; D016176:T-Lymphocyte Subsets / Q000276:immunology
D019380:Anti-HIV Agents; D004279:DNA, Viral; D063065:Organophosphonates; D012367:RNA, Viral; D000225:Adenine; D002331:Carnitine; C106812:adefovir dipivoxil