TY - JOUR
T1 - Anti-human immunodeficiency virus (HIV) activity, safety, and pharmacokinetics of adefovir dipivoxil (9-[2-(bis-pivaloyloxymethyl)- phosphonylmethoxyethyl]adenine) in HIV-infected patients
AU - Barditch-Crovo, P.
AU - Toole, J.
AU - Hendrix, C. W.
AU - Cundy, K. C.
AU - Ebeling, D.
AU - Jaffe, H. S.
AU - Lietman, P. S.
N1 - Funding Information:
Received 18 July 1996; revised 26 March 1997. Presented in part: Eighth International Conference on Antiviral Research, Santa Fe, New Mexico, April 1995 (abstract 9). Informed consent was obtained from all study participants. Human experimentation guidelines of both the US Department of Health and Human Services and The Johns Hopkins Medical Institutions were followed in the conduct of this clinical research. The study was approved by the local Institutional Review Board, Johns Hopkins Joint Committee on Clinical Investigation. Financial support: Gilead Sciences; NIH (RR-00035); Sandoz (Scholar Award to P. B.-C.). J.T., K.C., D.E., and H.S.J. are stockholders in Gilead Sciences, Inc. The views expressed in this article are those of the authors and do not reflect the official policy of the Department of Defense or other departments of the US government. Reprints or correspondence: Dr. Patricia Barditch-Crovo, 527 Osler Building, Johns Hopkins Hospital, 600 N. Wolfe St., Baltimore, MD 21287.
PY - 1997
Y1 - 1997
N2 - 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.
AB - 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.
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U2 - 10.1086/514057
DO - 10.1086/514057
M3 - Article
C2 - 9237705
AN - SCOPUS:0030842430
SN - 0022-1899
VL - 176
SP - 406
EP - 413
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 2
ER -