AIDS. 16(9):1257-1263, JUNE 14TH, 2002

PMID: 12045491

Issn Print: 0269-9370

Publication Date: June 14th, 2002


Share this on facebook   Share this on Twitter   Share this on LinkedIn   Email this article  



Print

Tenofovir DF in antiretroviral-experienced patients: results from a 48-week, randomized, double-blind study

Robert Schooley;Peter Ruane;Robert Myers;Gildon Beall;Harry Lampiris;Daniel Berger;Shan-Shan Chen;Michael Miller;Erica Isaacson;Andrew Cheng;

+ Author Information


    loading  Checking for direct PDF access through Ovid

Abstract

ObjectiveTo evaluate the safety and efficacy of once daily doses of tenofovir DF (TDF) administered in combination with other antiretroviral therapy (ART) in treatment-experienced HIV-1-infected patients with incomplete virological suppression.DesignOne-hundred and eighty-nine subjects with plasma HIV-1 RNA levels between 400 and 100 000 copies/ml and stable ART (≥ 8 weeks) were randomized (2:2:2:1 ratio) to add TDF 75 mg, 150 mg, or 300 mg or placebo to existing ART in a double-blinded manner. After 24 weeks, patients initially randomized to placebo received blinded TDF 300 mg.MethodsEfficacy was analyzed by the mean changes HIV-1 RNA levels (log10 copies/ml plasma; DAVGxx) from week 0 to weeks 4, 24, and 48. Safety was analyzed by incidence of grade 3 or 4 clinical and laboratory adverse events.ResultsAt baseline, patients had mean 4.6 years prior ART use with 94% having HIV-1 with nucleoside-associated resistance mutations. There were statistically significant decreases in DAVG4 and DAVG24 for all doses of TDF compared with placebo, with the greatest effect seen with TDF 300 mg (DAVG4, −0.62, P < 0.001; DAVG24, −0.58;P < 0.001; DAVG48, −0.62). The incidence of adverse events was similar among the TDF groups and placebo through week 24. Throughout the 48-week study, no significant changes in renal function were observed.ConclusionsIn treatment-experienced patients with baseline nucleoside resistance mutations, TDF provided dose-related, durable reductions in HIV-1 RNA. Through 24 weeks, the safety profile of TDF was similar to that of placebo.

Related Topics

    Related Articles

        loading  Loading Related Articles